Side effects of zocor 20 mg

Contents

Zocor

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Scandinavian Simvastatin Survival Study

Table 2: Adverse Reactions Reported Regardless of Causality by ≥2% of Patients Treated with ZOCOR and Greater than Placebo in 4S

ZOCOR
(N = 2,221)
%
Placebo
(N = 2,223)
%
Body as a Whole
Edema/swelling 2.7 2.3
Abdominal pain 5.9 5.8
Cardiovascular System Disorders
Atrial fibrillation 5.7 5.1
Digestive System Disorders
Constipation 2.2 1.6
Gastritis 4.9 3.9
Endocrine Disorders
Diabetes mellitus 4.2 3.6
Musculoskeletal Disorders
Myalgia 3.7 3.2
Nervous System/ Psychiatric Disorders
Headache 2.5 2.1
Insomnia 4.0 3.8
Vertigo 4.5 4.2
Respiratory System Disorders
Bronchitis 6.6 6.3
Sinusitis 2.3 1.8
Skin / Skin Appendage Disorders
Eczema 4.5 3.0
Urogenital System Disorders
Infection, urinary tract 3.2 3.1

Heart Protection Study

In the Heart Protection Study (HPS), involving 20,536 patients (age range 40-80 years, 25% women, 97% Caucasians, 3% other races) treated with ZOCOR 40 mg/day (n=10,269) or placebo (n=10,267) over a mean of 5 years, only serious adverse reactions and discontinuations due to any adverse reactions were recorded. Discontinuation rates due to adverse reactions were 4.8% in patients treated with ZOCOR compared with 5.1% in patients treated with placebo. The incidence of myopathy/rhabdomyolysis was <0.1% in patients treated with ZOCOR.

Other Clinical Studies

In a clinical trial in which 12,064 patients with a history of myocardial infarction were treated with ZOCOR (mean follow-up 6.7 years), the incidence of myopathy (defined as unexplained muscle weakness or pain with a serum creatine kinase >10 times upper limit of normal ) in patients on 80 mg/day was approximately 0.9% compared with 0.02% for patients on 20 mg/day. The incidence of rhabdomyolysis (defined as myopathy with a CK >40 times ULN) in patients on 80 mg/day was approximately 0.4% compared with 0% for patients on 20 mg/day. The incidence of myopathy, including rhabdomyolysis, was highest during the first year and then notably decreased during the subsequent years of treatment. In this trial, patients were carefully monitored and some interacting medicinal products were excluded.

Other adverse reactions reported in clinical trials were: diarrhea, rash, dyspepsia, flatulence, and asthenia.

Laboratory Tests

Marked persistent increases of hepatic transaminases have been noted . Elevated alkaline phosphatase and γ-glutamyl transpeptidase have also been reported. About 5% of patients had elevations of CK levels of 3 or more times the normal value on one or more occasions. This was attributable to the noncardiac fraction of CK.

Adolescent Patients (Ages 10-17 years)

In a 48-week, controlled study in adolescent boys and girls who were at least 1 year post-menarche, 10-17 years of age (43.4% female, 97.7% Caucasians, 1.7% Hispanics, 0.6% Multiracial) with heterozygous familial hypercholesterolemia (n=175), treated with placebo or ZOCOR (10-40 mg daily), the most common adverse reactions observed in both groups were upper respiratory infection, headache, abdominal pain, and nausea .

Postmarketing Experience

Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following additional adverse reactions have been identified during postapproval use of simvastatin: pruritus, alopecia, a variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails), dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, vomiting, anemia, erectile dysfunction, interstitial lung disease, rhabdomyolysis, hepatitis/jaundice, fatal and non-fatal hepatic failure, and depression.

There have been rare reports of immune-mediated necrotizing myopathy associated with statin use .

An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.

There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

Read the entire FDA prescribing information for Zocor (Simvastatin)

Zocor Side Effects

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ZOCOR®

Simvastatin

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about ZOCOR. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking ZOCOR against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What ZOCOR is used for

ZOCOR helps to lower cholesterol and triglyceride levels.

ZOCOR is used in people who have coronary heart disease (CHD) or who are at high risk of CHD (for example, if they have diabetes, a history of stroke, or other blood vessel disease).

ZOCOR may be used in these people, regardless of their cholesterol level to:

  • help prolong life by reducing the risk of a heart attack
  • reduce the risk of stroke
  • reduce the need for surgery to increase blood flow to the heart
  • reduce the need for hospitalisation due to angina.

Cholesterol

Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things, including building cell walls, making bile acids (which help to digest food) and certain hormones. However, too much cholesterol can be a problem.

Your body makes cholesterol, but it also comes from food.

Normally the body balances the cholesterol it makes with the cholesterol it gets from food. This means if more cholesterol comes from food, less is made by the body. However, if you eat a diet high in fat, your body may not keep this balance and your cholesterol levels rise.

High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol.

When you have high levels of cholesterol, it may ‘stick’ to the inside of your blood vessels instead of being carried to the parts of the body where it is needed. Over time, this can form hard areas, called plaque, on the walls of blood vessels, making it more difficult for the blood to flow. This blocking of your blood vessels can lead to coronary heart disease (such as heart attack and angina), and stroke.

In people with CHD, ZOCOR may slow down the hardening of blood vessels and reduce the risk of developing new plaques.

There are different types of cholesterol, called LDL and HDL cholesterol. LDL cholesterol is the ‘bad’ cholesterol that can block your blood vessels. HDL cholesterol, on the other hand, is the ‘good’ cholesterol that is thought to remove the bad cholesterol from the blood vessels.

Triglycerides

Triglycerides are an energy source for the body. However, as with cholesterol, too much triglycerides can be a problem.

How ZOCOR works

ZOCOR belongs to a group of medicines known as HMG-CoA reductase inhibitors. It works by reducing the amount of cholesterol made by the liver. In terms of good and bad cholesterol, ZOCOR reduces the bad cholesterol and raises the good cholesterol.

ZOCOR does not reduce the cholesterol and triglycerides that come from fat in food.

Therefore, when you are taking ZOCOR, you also need to follow a low fat diet and other measures, such as exercise and weight control.

In most people, there are no symptoms of high cholesterol or triglycerides. Your doctor can measure your cholesterol and triglycerides with a simple blood test.

Safety and effectiveness have been studied in 10-17 year old boys and in girls, who had started their menstrual period at least one year before (see How to take ZOCOR). ZOCOR has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Your doctor may have prescribed ZOCOR for another reason. Ask your doctor if you have any questions about why ZOCOR has been prescribed for you.

ZOCOR is not addictive.

Before you take ZOCOR

When you must not take it

Do not take ZOCOR if:

  • you have an allergy to ZOCOR or other brands of simvastatin, or to any of the ingredients listed at the end of this leaflet
    Symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath, swelling of the tongue or face, or painful joints.
  • you are pregnant or breast-feeding
    Your baby may absorb this medicine in the womb or from breast milk and therefore there is a possibility of harm to the baby.
  • you have liver disease
  • you have had muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides
  • the packaging is torn or shows signs of tampering
  • the expiry date on the pack has passed.
    If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking ZOCOR, talk to your doctor.

Before you start to take it

Tell your doctor if:

  1. you intend to become pregnant or plan to breast feed

ZOCOR should not be used during pregnancy or while breast-feeding.

  1. you have unexplained muscle pain, tenderness or weakness not caused by exercise. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage that can lead to death.

Your doctor may do a blood test to check for certain muscle problems.

  1. you are Asian
  2. you have ever had liver disease

Your doctor will do a blood test to make sure you have no problems with your liver.

  1. you have kidney disease or any other medical problems
  2. you drink alcohol regularly
  3. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell them before you take any ZOCOR.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines should not be taken with ZOCOR as they may increase the risk of muscle side effects with ZOCOR. It is particularly important to tell your doctor if you are taking:

  • nefazodone, used to treat depression
  • medicines containing cobicistat (a drug used in the treatment of HIV infection)
  • protease inhibitors, including indinavir, nelfinavir, ritonavir, saquinavir, used to treat HIV infection
  • certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir)
  • gemfibrozil, used to treat high cholesterol levels
  • ciclosporin, used to suppress the immune system
  • danazol
  • erythromycin, clarithromycin, telithromycin and fusidic acid antibiotics used to treat infections
  • ketoconazole, itraconazole, posaconazole and voriconazole, used to treat certain fungal infections

If you are taking any of the above, your doctor may suggest stopping ZOCOR temporarily or permanently.

Some medicines and ZOCOR may interfere with each other. Because taking ZOCOR with any of the following drugs can increase the risk of muscle problems (see Side Effects), it is particularly important to tell your doctor if you are taking:

  • other medicines to lower cholesterol levels, for example, other fibrates, nicotinic acid (also known as niacin)
  • warfarin, or other drugs used to prevent blood clots
  • colchicine, used for gout
  • verapamil, diltiazem or amlodipine, used to treat high blood pressure, angina or other heart conditions
  • lomitapide (a drug used to treat a serious and rare genetic cholesterol condition)
  • amiodarone, used to treat irregular heart beat
  • digoxin, used to treat heart failure
  • Certain hepatitis C antiviral agents, such as elbasvir or grazoprevir
  • daptomycin, a drug used to treat complicated skin and skin structure infections and bacteraemia

These medicines may be affected by ZOCOR, may affect how well it works, or may increase the risk of side effects with ZOCOR. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking ZOCOR.

You should also tell any doctor who is prescribing a new medication for you that you are taking ZOCOR.

How to take ZOCOR

How much to take

Take ZOCOR only when prescribed by your doctor.

Your doctor will tell you how many tablets you need to take each day. This depends on your cholesterol and triglyceride levels and other factors, such as kidney disease.

For adults, the recommended starting dose is 10mg or 20 mg per day, taken in the evening, which may need to be increased up to 80 mg daily to have the best effect.

Because of the increased risk of muscle problems, the 80 mg dose is only for patients at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

People with CHD or risk factors for CHD are usually started on 40 mg per day, taken in the evening.

For children (10-17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.

Swallow ZOCOR with a glass of water.

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

When to take it

Take ZOCOR once a day in the evening. The liver produces its greatest amount of cholesterol when the body is at rest and when there is no dietary intake. For most people this is at night when asleep. Therefore, ZOCOR is more effective when taken in the evening. A good time would be after your evening meal. However, it does not matter whether you take it before or after food.

Take ZOCOR at about the same time each evening. Taking your tablet(s) at the same time each evening will have the best effect. It will also help you remember when to take the tablets.

How long to take it

ZOCOR helps lower your cholesterol. It does not cure your condition. Therefore, you must continue to take it as directed by your doctor if you expect to lower your cholesterol and keep it down. You may have to take cholesterol-lowering medicine for the rest of your life. If you stop taking ZOCOR, your cholesterol levels may rise again.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your tablet(s) as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering to take your tablets, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much ZOCOR. Do this even if there are no signs of discomfort or poisoning.

While you are using ZOCOR

Things you must do

If you become pregnant while you are taking ZOCOR, stop taking it and contact your doctor immediately.

Have your blood fats checked when your doctor says, to make sure ZOCOR is working.

If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking ZOCOR.

If you are about to have elective surgery, tell your doctor that you are taking ZOCOR. Your doctor may suggest stopping the tablets a few days before surgery.

Things you must not do

Do not give ZOCOR to anyone else, even if they have the same condition as you.

Things to be careful of

Avoid drinking large quantities of alcohol. Drinking large quantities of alcohol may increase your chance of ZOCOR causing liver problems.

Grapefruit juice should be avoided while taking ZOCOR. Grapefruit juice contains one or more components that alter the metabolism of some medicines, including ZOCOR

Be careful driving or operating machinery until you know how ZOCOR affects you. ZOCOR generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, ZOCOR may cause dizziness in some people. Make sure you know how you react to ZOCOR before you drive a car or operate machinery.

Changes to lifestyle that may help reduce the chance of coronary heart disease

Lowering high cholesterol can help reduce your chances of having coronary heart disease (CHD). However, your chances of having CHD may be increased by several other factors including high blood pressure, cigarette smoking, diabetes, excess weight, family history of CHD, being a male and being a woman who has reached menopause.

Some self help measures suggested below may help your condition and help reduce your chances of having CHD. Talk to your doctor, pharmacist, or dietician about these measures and for more information.

  • Diet
    – continue the low fat diet recommended by your doctor, dietician or pharmacist.
  • Weight
    – your doctor may advise you to lose weight if you are overweight.
  • Exercise
    – make exercise a part of your routine – walking is good. Ask your doctor for advice before starting exercise.
  • Smoking
    – your doctor may advise you to stop smoking or at least cut down.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ZOCOR.

ZOCOR helps most people with high cholesterol, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following and they worry you:

  • constipation, diarrhoea, wind
  • stomach upset or pain, feeling sick (nausea)
  • headache
  • dizziness

These are the more common side effects of ZOCOR. For the most part these have been mild and short-lived.

Tell your doctor immediately if you notice any of the following:

  • aching muscles, muscle tenderness or weakness, not caused by exercise (in very rare cases this may not go away after stopping ZOCOR)
  • brown/black coloured urine

On rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage that can lead to death.

The risk of muscle problems is greater for:

  • patients taking higher doses of ZOCOR, particularly the 80 mg dose
  • older patients (65 years of age and older)
  • female patients
  • patients with abnormal kidney function
  • patients with thyroid problems.

Tell your doctor immediately if you notice any of the following:

  • tingling in the hands or feet
  • signs of anaemia, such as tiredness, being short of breath, and looking pale
  • fever, generally feeling unwell
  • skin rash, itchiness
  • pinkish, itchy swellings on the skin, also called hives or nettlerash
  • painful, swollen joints
  • bruising more easily than normal
  • larger breasts than normal in men

These may be serious side effects of ZOCOR. Some of these may be symptoms of an allergic reaction to ZOCOR. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you notice any of the following:

  • swelling of the face, lips, mouth, tongue, and/or throat that may cause difficulty in swallowing or breathing
  • shortness of breath

These are serious side effects. If you have them, you may have had a serious allergic reaction to ZOCOR. You may need urgent medical attention or hospitalisation. Serious side effects are rare.

Also, tell your doctor if you notice:

  • hair loss
  • muscle cramps
  • trouble sleeping
  • poor memory, memory loss, confusion
  • feelings of depression
  • erectile dysfunction
  • breathing problems including persistent cough and/or shortness of breath or fever

These are other side effects that have been reported with ZOCOR.

Liver problems can also occur and may be serious. Your doctor will do blood tests to check your liver.

Tell your doctor immediately if you have the following symptoms of liver problems:

  • feel tired or weak
  • loss of appetite
  • upper belly pain
  • dark urine
  • yellowing of your skin or the whites of your eyes

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using ZOCOR

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.

Keep ZOCOR in a cool dry place where the temperature stays below 30°C. Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking ZOCOR or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

ZOCOR comes in five types of tablets:

  • ZOCOR 5 mg – buff coloured, oval-shaped tablet with “MSD 726” marked on one side and “Zocor 5” on the other side
  • ZOCOR 10 mg – peach coloured, oval-shaped tablet with “MSD 735” marked on one side
  • ZOCOR 20 mg – tan coloured, oval-shaped tablet with “MSD 740” marked on one side
  • ZOCOR 40 mg – brick-red coloured, oval-shaped tablet with “MSD 749” marked on one side
  • ZOCOR 80 mg – brick-red coloured, capsule-shaped tablet with “543” marked on one side and “80” on the other.

A starter pack of ZOCOR contains 5 tablets. A trade pack of ZOCOR contains 30 tablets.

Ingredients

Active ingredient:

ZOCOR 5 mg – 5 mg simvastatin per tablet

ZOCOR 10 mg – 10 mg simvastatin per tablet

ZOCOR 20 mg – 20 mg simvastatin per tablet

ZOCOR 40 mg – 40 mg simvastatin per tablet

ZOCOR 80 mg – 80 mg simvastatin per tablet

Inactive ingredients:

  • butylated hydroxyanisole
  • ascorbic acid
  • citric acid monohydrate
  • cellulose
  • starch – pregelatinised maize
  • magnesium stearate
  • lactose monohydrate
  • hypromellose
  • hyprolose
  • titanium dioxide
  • talc
  • carnauba wax
  • iron oxide yellow CI77492 (5 mg, 10 mg, 20 mg and 80 mg tablets)
  • iron oxide red CI77491 (10 mg, 20 mg, 40 mg and 80 mg tablets)

ZOCOR does not contain gluten, sucrose, tartrazine or any other azo dyes.

Manufacturer/Supplier

ZOCOR is supplied in Australia by:

Merck Sharp & Dohme (Australia) Pty Limited
A.B.N. 14 000 173 508
Level 1, Building A, 26 Talavera Road
Macquarie Park NSW 2113

This leaflet was prepared in March 2019.

This CMI leaflet was current at the time of printing. To check if it has been updated ask your pharmacist.

Australian Register Numbers:

ZOCOR 5 mg – AUST R 39917

ZOCOR 10 mg – AUST R 65976

ZOCOR 20 mg – AUST R 65975

ZOCOR 40 mg – AUST R 58864

ZOCOR 80 mg – AUST R 65977

S-WPPI-MK0733-T-122018

Published by MIMS May 2019

1) Atorvastatin causes cancer

Nope. There is no convincing evidence that atorvastatin — or any statin — increases the risk of cancer.

In fact, studies in the last few years suggest a protective effect of statins against breast cancer, pancreatic cancer, and lung cancer in some patients. A recent large meta-analysis also found that statins can reduce the risk of cancer in type 2 diabetics.

2) Atorvastatin is bad for your liver

Very rarely (in 0.5% to 3% of cases), statins can cause your liver blood tests to rise, which in the past had doctors pretty worried. If this happens, it is usually in the first 3 months of treatment and is seen with people taking higher doses of statins.

But studies have also shown that people taking statins actually have the same rate of liver injury as people not taking statins. Because of this, the FDA no longer recommends monitoring liver function tests in people taking statins (unless they already have liver problems).

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3) Atorvastatin causes joint pain or arthritis

Statins can cause muscle aches, or myalgia, in 7% of people taking them. But even though they shouldn’t cause joint aches, studies suggest certain statin users are more likely to have joint aches. We’re not sure why that is, and there isn’t much research into this. But one theory is that joint aches are more common in older folks who also happen to take more statins.

One thing is for sure: If you’re getting new pain in your hips, knees, shoulders, and the small joints of the hands and feet, speak to your doctor about it. It’s unlikely to be your statin causing this.

4) Atorvastatin causes depression

Some folks have expressed concerns about depression and increased suicide risk with atorvastatin, but this does not appear to be true. Atorvastatin is not associated with an increased risk of suicide or depression.

5) Atorvastatin causes sleepiness

While some medications may make you tired, the statin drugs like atorvastatin should not make you sleepy.

6) Atorvastatin causes headache

Headache is one of the most common reasons a person visits their primary care doctor, but headaches do not appear to be related to atorvastatin use. Atorvastatin should not worsen or cause a headache.

7) Atorvastatin causes rash and hives

Atorvastatin has not been reported to cause hives or rash.

Bonus myth: Atorvastatin causes erectile dysfunction

No, and in fact it may be the opposite.

In men with erectile dysfunction, atorvastatin leads to improved erectile function, likely a result of lowered blood cholesterol. Additionally, atorvastatin started post-operatively contributes to earlier recovery of erectile function in men after prostate surgery.

– – –

Dr. O

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  • Do Statins Cause Weight Gain?

    Friday, May 16, 2014

    Statins are powerful drugs to lower cholesterol and have probably saved millions of lives (or rather, delayed millions of deaths) in people who have proven atherosclerosis (i.e. in secondary prevention). However, as all medications, they do have their adverse effects and their use in people with no clinical signs of atherosclerotic disease remains controversial.

    Now, an article by Takehiro Sugiyama and colleagues, published in JAMA Internal Medicine, points to another possible “adverse” effect of statins – weight gain.

    The researchers examined the relationship between changes in calorie and fat intake between stating uses and non-users in a nationally representative sample of 28,000 US adults, 20 years or older, from the National Health and Nutrition Examination Survey (NHANES), 1999 through 2010.

    While back in 1999-2000 caloric intake was significantly lower for statin users compared with nonusers (by about 180 kcal/d) this difference between the groups became smaller as time went by.

    In contrast, no significant change was observed among nonusers during the same study period.

    As with calories, statin users back in 1999-2000 ate about 10 g less fat perday than non-userers, but “noramlised” their fat intake as time went by.

    In line with this, BMI increased more among statin users (+1.3) but not in non-users (+0.4) during this time period.

    The authors interpret these finding to indicate that over time efforts aimed at dietary control among statin users may be becoming less intensive as statin users (and their health-care providers) may be relying more and more on the pills to do the job.

    As there is no biological plausible link between statin use and an increase in appetite, this does seem a very reasonable hypothesis.

    Perhaps not unlike the common observation that people starting exercise programs may begin eating unhealthier diets (or simply more calories) because they feel “protected” by their physical efforts.

    I guess we could all do a better job in reminding ourselves that pharmacotherapy should always supplement healthier lifestyles rather than replace them.

    @DrSharma
    Las Vegas, NV

    Statin Users Can Experience Weight Gain with Diabetes Onset

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    Statins will lower cholesterol and increase weight in diabetic patients….

    Statins, HMG-CoA reductase inhibitors, have been on the market for many years. Statins are very effective lipid-lowering agents with minimal side effect profile. Statins are classified by their potency; high potency statins include atorvastatin and rosuvastatin. Other statins include fluvastatin, lovastatin, pravastatin and simvastatin. Statins work by inhibiting the rate-limiting step in cholesterol biosynthesis. The most common adverse effects include: muscle and joint aches, nausea, diarrhea and constipation. More serious adverse effects include: liver damage, rhabdomyolysis, hyperglycemia and neurologic effects.

    Previous studies have evaluated and proven the efficacy and safety of statins. Many studies focus on which statin has the least occurrences of muscle toxicities. Other studies have evaluated ways to safely combine a statin and another agent to better control cholesterol. Some studies are even testing statins with anti-hypertensive agents. In more recent years, many researchers have noted the increased incidence of hyperglycemia in patients using statin therapy.

    This study evaluated 7,595 patients without overt diabetes. The researchers wanted to investigate whether change in body weight predicts new-onset diabetes mellitus. The participants were randomized to atorvastatin 10 mg or 80 mg/day and followed for approximately 4.9 years. Of the 7,595 participants, 659 patients developed diabetes. When the data was further evaluated, researchers found that 8.1% of the newly-diagnosed diabetics were taking atorvastatin 10 mg; 9.2% of the newly-diagnosed diabetics were taking atorvastatin 80 mg. One year after randomization, both men and women participants had significant weight gain. The most weight gain occurred in patients that developed diabetes within the study follow-up period. Similar weight gain was observed in patients with normal glucose levels. They concluded by warning patients and prescribers the importance of weight control while taking statins.

    Practice Pearls:

    • Older cholesterol guidelines focused primarily on managing LDL levels; the new guidelines stress future risks for heart disease and stroke.
    • New cholesterol guidelines also suggest that with more people taking statins, there would be 475,000 less cardiac events.
    • Not having enough cholesterol can interfere with memory and hormone production.

    Ong K, Waters D, Messia M, et. al. Effect of Change in Body Weight on Incident Diabetes Mellitus in Patients with Stable Coronary

    Artery Disease Treated with Atorvastatin (From the Treating to New Target Study). American Journal of Cardiology. 2014 Mar.

    Simvastatin and Weight Gain

    Weight gain is not recognized as a side effect of simvastatin (Zocor, Simvacor), but it sometimes reported by patients taking this cholesterol-reducing medication.

    There are contrasting views as to whether simvastatin can indeed cause weight gain or not. Some healthcare providers recognize weight gain as a possible side effect of this medication. In a study headed by Dr. Beatrice Golomb of the University of California-San Diego School of Medicine, it suggested that simvastatin can cause significant sleep problems which can subsequently lead to weight gain and aggression. It is the only statin that has shown to cause disruption in sleep pattern.

    The study was participated by 1,000 healthy men and women who were currently taking cholesterol-reducing drugs (simvastatin and pravastatin) or placebo drugs. Experts suggest that the sleep disturbance may be due to the fact that simvastatin is capable of crossing the brain. Unlike other cholesterol-lowering drugs, simvastatin is fat soluble which allows it to readily cross into the brain and affect the cell membranes. The brain regulates sleeping pattern, any disruption or alteration in its normal physiology can result in adverse effects on sleep quality.

    The researchers further stressed that the disruption in sleep pattern can affect the patient’s quality of life and have negative effects on health that includes weight gain and insulin resistance. Patients who experienced sleep problems while taking simvastatin are at increased risk of gaining extra weight compared to others. Therefore, if you are on simvastatin therapy and develop sleep problems, you should consult your healthcare provider.

    Take note, however, that these changes in sleep pattern can have varying effects on different patients. It is also possible for patients to lose instead of gaining weight.

    Managing Weight Gain

    Although weight gain is rarely reported by patients taking simvastatin, if it does occur you may need to seek medical attention. Sudden weight gain may be caused by other medical conditions and must be evaluated carefully.

    If you notice weight gain while on simvastatin therapy, there are several things that you can do to manage your weight. First of all, you should adjust your diet. It should contain lots of vegetables, fruits, grains, and limit intake of fats and other sugary products. As much as possible, choose lean meat, fish, and poultry over processed foods. Regular physical activity or a good 30 minute exercise every day is also recommended.

    If the weight gain continues despite a change in your lifestyle, you should talk to your physician. He or she will give you appropriate recommendations. A dose adjustment or change in medication may be necessary depending on your condition.

    Statins pills ‘may cause fatigue’

    Cholesterol-lowering statin drugs may cause tiredness, according to The Daily Telegraph. The newspaper said that doctors should consider this possible side effect before prescribing statins, currently taken by millions of patients.

    The news is based on a trial testing statins in people with no history of heart disease or diabetes. The doctors behind the well-conducted study said that fatigue has been anecdotally reported as a side effect of statins, so they set out to test this. The study assessed tiredness by asking people about their general energy levels and fatigue when exerting themselves. Its found greater levels of fatigue in people taking statins compared with those taking dummy pills, particularly among women. Although the research found a worsening of fatigue with statins, it did not assess whether this actually equated to a reduction in people’s quality of daily life.

    All drugs have side effects and doctors take these into account when prescribing medication. This information on fatigue will help doctors to make better informed decisions when considering prescribing statins.

    The potential benefits of taking statins to a patient at high risk of cardiovascular problems may outweigh the risk of side effects such as increased levels of fatigue, while the opposite could be true in a person at low risk of cardiovascular problems. This balance should be decided on a patient-by-patient basis by the doctor and the patient, and people should not stop taking their statins based on this news.

    Where did the story come from?

    The study was carried out by researchers from the University of California and was funded by the university and the US National Heart, Lung, and Blood Institute. The study was published online in the peer-reviewed journal, Archives of Internal Medicine.

    The Daily Telegraph has covered this study appropriately. However, the Daily Mail’s coverage suggested that 40% of women taking statins were “exhausted” – but the study did not assess “exhaustion”, only worsening of fatigue, which may not equate to exhaustion. The 40% figure appears to be based on the way the research paper itself reported its results, although the results weren’t very clear.

    The Mail’s coverage also implied that scientists had said people at low risk of cardiovascular problems were better off not taking statins. However, the study did not weigh up the overall balance of benefits and harms of statins, and the authors of this new research actually said their findings “merit consideration when prescribing or contemplating use of statins”, not that they should not be used at all in individuals with low cardiovascular risk.

    What kind of research was this?

    This was a placebo-controlled, randomised controlled trial (RCT) assessing the effects of statins on non-heart related outcomes. Trials using this design randomly assign participants to take either an active drug (in this case a statin) or a dummy “placebo” drug, and compare their results. Trials of this type are considered to offer the best level of evidence about the benefits and harms that can be attributed to a drug. This is because the randomisation process should create balanced groups, who should differ only in the medicines being tested in the trial, and not in other characteristics that might affect their outcomes.

    In this analysis the researchers were interested in general fatigue and fatigue after or during exertion, which was one of the subsidiary outcomes of the trial. The researchers said that observational evidence has suggested statins are associated with fatigue, but that no RCTs have assessed this link.

    What did the research involve?

    The researchers enrolled 1,016 people (692 men, 324 women; average age around 57 years old) who did not have heart disease or diabetes. They randomly assigned the participants to receive either one of two statins (simvastatin or pravastatin) or a dummy “placebo” capsule daily for six months. At six months, the researchers looked at how energy levels and fatigue had changed between the groups.

    The men in the study were aged 20 or over, while the women were described as “non-procreative” – it was not clear whether this meant the women were past menopause or not intending to have children. All capsules used in the study were visually identical so that the patients and researchers assessing them did not know who was taking which drug until the end of the study. This was so that the participants, the researchers’ assessments of the participants and analysis of the data during the trial would not be influenced by this knowledge. At the start of the study all participants were asked to rate their energy levels and 397 of them were asked to rate levels of fatigue on exertion on a scale from zero (none) to 10 (maximum possible). The participants were also asked about how often they did vigorous exercise lasting more than 20 minutes.

    After six months, the participants were asked to rate how their energy levels and levels of fatigue on exertion had changed from the start of the study, on a five-point scale ranging from “much less” to “much more”. The researchers used the information to give an overall measure of how much more or less fatigued a person was at the end of the study.

    The researchers pooled results for both statin groups in their analysis and compared them with the placebo group. The researchers also looked at whether the effect on fatigue was the same in men and women.

    What were the basic results?

    The researchers found that participants taking the statins showed a greater increase in overall fatigue than those taking placebo. They found that the effect was particularly pronounced in women.

    The fatigue scores being compared had two components: general energy levels and fatigue upon exertion. They said that, compared with a placebo, statin use resulted in the equivalent of:

    • 4-in-10 treated women reporting having “worse” energy levels or exertional fatigue and the remaining 6 out of 10 women reporting no change.
    • 2-in-10 treated women reporting having “worse” energy levels and “worse” exertional fatigue and the remaining 8 out of 10 women reporting no change.
    • 2-in-10 treated women reporting being “much worse” on either energy levels or exertional fatigue and the remaining 6 out of 10 women reporting no change.
    • 1-in-10 treated women reporting being “much worse” on both energy levels and exertional fatigue and the remaining 9 out of 10 women reporting no change.

    The researchers used these examples above to explain what the differences seen on the average scores could mean, but did not report which of these scenarios they actually observed in their trial (that is, the exact proportion of women reporting worse or much worse energy levels and exertional fatigue).

    How did the researchers interpret the results?

    The researchers concluded that, to their knowledge, this was the first RCT that has confirmed the earlier anecdotal observations that statins are associated with decreased energy levels and increased fatigue during and following exertion. They said that these effects “merit consideration” when prescribing statins, particularly in groups where statins are not expected to be able to produce an overall reduction in risk of death or heart disease.

    Conclusion

    The results of this randomised controlled trial (RCT) suggest that statins are associated with an increase in fatigue levels, particularly in women. An RCT is the best way to look at the beneficial and harmful effects of drugs. However, this analysis was only intended to be exploratory, and ideally fatigue would be assessed as an outcome in other RCTs to confirm these findings.

    There are some limitations to this research, which include the difficulties in interpreting what the reported worsening in fatigue means in terms of a person’s daily life. It was also unclear whether the participants were asked to perform a standard exertion test (on a treadmill for example) to ensure people interpreted “exertion” similarly. Future studies aiming to confirm these results would ideally also assess the impact that any change in fatigue has on a person’s quality of life.

    The way the results are reported also makes it difficult to say whether several women experienced a smaller change in fatigue or if a few women experienced a larger change in fatigue after taking statins. The average ages of the male and female participants were not reported separately, so it was not clear whether the women in the study were older than the men in the study, which might explain why the statins had a greater effect on their fatigue levels.

    Overall, this study adds to what is known about the potential side effects of statins: all drugs have side effects and, when they are prescribed, doctors will consider and discuss the balance of benefits and risks with each individual patient. Information on side effects helps doctors and patients to make better informed decisions.

    The potential benefits in taking statins to a patient at high risk of cardiovascular problems may outweigh the risk of side effects such as increased levels of fatigue, whereas the opposite may be true in a person at low risk of cardiovascular problems. This balance should be decided on an individual basis by the doctor in discussion with their patient, and people should not stop taking their statins based on this news.

    Analysis by Bazian
    Edited by NHS Website

    Links to the headlines

    Statins ’cause fatigue and should be prescribed with care’

    The Daily Telegraph, 12 June 2012

    Links to the science

    Golomb BA, Evans MA, Dimsdale JE, White HL.

    Effects of Statins on Energy and Fatigue With Exertion: Results From a Randomized Controlled Trial

    Archives of Internal Medicine, 2012

    1. Blood pressure medications

    Why they’re prescribed: All blood pressure medications — and there are at least eight categories of them — are used to lower the pressure inside blood vessels, so the heart doesn’t have to work as hard to pump blood throughout the body.

    Top-selling blood-pressure medications include lisinopril (Prinivil, Zestril), an ACE inhibitor; amlodipine (Norvasc), a calcium channel blocker; hydrochlorothiazide (HCTZ and various other brand names), a thiazide diuretic; furosemide (Lasix), a loop diuretic; and metoprolol (Lopressor, Toprol), a beta blocker. Fatigue is also one of the most common side effects that occurs with aliskiren (Tekturna, Tekturna HCT), which belongs to a newer class of drugs called renin inhibitors.

    How they can cause fatigue: Blood-pressure medications may slow down the pumping action of the heart as well as depress the entire central nervous system, or, in the case of diuretics, deplete electrolytes that the body needs.

    Check the safety information that comes with your blood pressure medications and you may well see “extreme tiredness” listed as a side effect. That’s an important sign that your fatigue could be drug-induced.

    Alternatives: Talk with your doctor or other health care provider about switching to another type of blood pressure medication. For older patients, a benzothiazepine calcium channel blocker, such as diltiazem (Cardizem), is often the best choice.

    An omega-3 fish oil supplement may help to lower your blood pressure, too. Be aware, though, that omega-3s can slightly raise levels of LDL or bad cholesterol, and other research has shown these may increase the risk of prostate cancer.

    A natural benefit: Omega-3 fatty acids are also thought to be natural fatigue fighters. One 2015 study shows that metabolism increased while resting and exercise heart rate dropped in older women who took omega-3 supplements that contain 2 g EPA, 1 g DHA for 12 weeks. However, whether omega-3 actually improves resting metabolism and exercise heart rate remains unclear because there are many conflicting studies.

    2. Statins and fibrates

    Why they’re prescribed: Statins and fibrates are used to treat high cholesterol. The top-selling statins are atorvastatin (Lipitor), rosuvastatin (Crestor) and simvastatin (Zocor); the top-selling fibrate is fenofibrate (Tricor).

    How they can cause fatigue: Studies show that statins stop the production of satellite cells that give rise to muscle tissue, stopping muscle growth. Some researchers have also suggested that statins interfere with the production of energy in cells in the same way that they interfere with the production of cholesterol.

    Muscle weakness and severe muscle aches throughout the body can be symptoms of statin-induced rhabdomyolysis, a rapid breakdown of skeletal muscle that causes muscle fibers to be released into the bloodstream. A substance called myoglobin within the muscle cells that is released can result in severe kidney damage and even kidney failure.

    Alternatives: If you’re among the many millions of older Americans without known coronary disease who are taking these drugs, ask your doctor or other health care provider about treating your slightly elevated cholesterol with a combination of sublingual (under-the-tongue) vitamin B12 (1,000 mcg daily), folic acid (800 mcg daily) and vitamin B6 (200 mg daily). Also, red yeast rice, a supplement first used in traditional Chinese medicine, has been found to be almost as effective as some of the moderate statins when used for short periods of time. But it also may cause some of the same muscle problems as the pharmaceutical products.

    3. Proton pump inhibitors

    Why they’re prescribed: Proton pump inhibitors are used to treat gastroesophageal reflux disease (GERD) and other similar disorders. More than 20 million Americans take prescription PPIs, including esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec) and pantoprazole (Protonix), some of which are available over the counter.

    How they can cause fatigue: Patients who take PPIs for as little as three months are at risk of low blood levels of magnesium, which can cause loss of appetite, fatigue and weakness, among other symptoms.

    Alternatives: The FDA has advised doctors and other health care providers to obtain serum magnesium levels before prescribing PPIs and then periodically thereafter.

    If you need to discontinue a PPI, you must do it very slowly. If you stop suddenly, you risk having GERD come back with more severe symptoms. Under your doctor’s guidance, you’ll gradually drop the dose in 20 mg increments, with 10 to 15 days between each taper, until you are completely off the drug. In some people the process takes even longer.

    If you still have severe reflux problems, you and your doctor may want to consider the use of an H2 blocker such as ranitidine (75 mg every 12 hours as needed).

    4. Benzodiazepines

    Why they’re prescribed: Benzodiazepines, commonly known as tranquilizers, are used to treat a variety of anxiety disorders, agitation and muscle spasms, and to prevent seizures. Because benzodiazepines have a sedative/hypnotic effect, they are sometimes used to treat insomnia and the anxiety component of depression.

    How they can cause fatigue: Benzodiazepines can cause sedation and fatigue by dampening activity in key parts of the central nervous system (CNS).

    People who take a benzodiazepine for more than two or three weeks may develop a tolerance to the drug, and over time may need to take increasing doses to achieve the same effect, only worsening their fatigue. Long-term effects also may include muscle weakness.

    It’s important to remember that it takes older people up to three times longer than younger people to flush these drugs out of their bodies. The ensuing buildup of the drug in the body puts older people at a much higher risk for experiencing fatigue and for developing physical or psychological dependence.

    Alternatives: Talk with your doctor or other health care provider. Many patients with mild anxiety or insomnia don’t need benzodiazepines at all, but stopping or reducing the dosage of a benzodiazepine should always be monitored by a professional, as serious withdrawal effects can occur.

    For all the conditions listed above, there are alternative drugs and nondrug treatments. Melatonin, in doses from 3 to 10 mg before bedtime, for instance, sometimes helps to reestablish healthy sleep patterns.

    5. Antihistamines

    Why they’re prescribed: Antihistamines are used to relieve or prevent the symptoms of allergic disorders (such as hay fever) or the common cold. Some antihistamines are also used to prevent motion sickness, nausea and vomiting, and to treat anxiety or insomnia.

    How they can cause fatigue: Antihistamines are CNS depressants. Most list tiredness and drowsiness among the potential side effects; some list weakness.

    Older people generally should not use diphenhydramine (Benadryl) — found in any sleep aid with a name ending in “PM” — because of its powerful sedative effects, which dramatically increase the risk of falls and bone fractures.

    Fatigue is also a listed side effect of fexofenadine (Allegra), another popular antihistamine, though perhaps less than other such drugs. Older people generally should not use this drug because their renal systems are unable to efficiently clear it, allowing the drug to build up in the body.

    Alternatives: Newer-generation antihistamines such as loratadine (Claritin) and cetirizine (Zyrtec) are better tolerated by older patients and present a lower risk for fatigue.

    6. Antidepressants

    Why they’re prescribed: While antidepressants are typically used to treat depression, they’re also frequently prescribed for anxiety disorders, eating disorders, obsessive compulsive disorder, chronic pain, smoking cessation and some hormone-mediated disorders, such as severe menstrual cramps.

    There are many different kinds of antidepressants, including tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), selective serotonin re-uptake inhibitors (SSRIs), dopamine antagonists and lithium, among others.

    How they can cause fatigue: Fatigue is a common side effect of antidepressant medications, especially during early weeks of treatment. Because antidepressants may also worsen fatigue brought on by another condition, teasing out causes is often difficult.

    Researchers have suggested that antidepressants may cause fatigue through their effect on the brain chemicals called neurotransmitters — chiefly serotonin and norepinephrine — and on hormones. Disruptions in the body’s secretion of the stress hormone cortisol, for example, have been closely linked to fatigue symptoms.

    Alternatives: Talk with your doctor or other health care provider about adjusting your antidepressant dose (side effects are often dose-related) or whether nondrug therapies might work just as well or better for you than a drug. You might also want to explore switching drugs, especially if you’re older and taking one of the tricyclic antidepressants, which are considered to be potentially inappropriate drugs for older people.

    7. Antipsychotics

    Why they’re prescribed: Antipsychotics are used to treat schizophrenia, bipolar disorder and other serious psychiatric conditions. Antipsychotics also are often prescribed “off label” to treat agitation and depression, among other conditions.

    How they can cause fatigue: Antipsychotics are drugs that dull the activity of the central nervous system. In studies, the side effects include fatigue, lethargy and weakness. Many of these drugs also lower dopamine levels, which can lead to drowsiness and sleepiness as well.

    Alternatives: Talk with your doctor or other health care provider about the possibility of reducing dosage or switching to another antipsychotic drug. And if you’ve been prescribed an antipsychotic to help you sleep or for some other off-label use, you’d be well-advised to seek out more proven, safer treatments for your symptoms. (For instance, in older patients, especially, these drugs increase the risk of heart failure.)

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