Side effect of hydralazine

Hydralazine Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 23, 2019.

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For the Consumer

Applies to hydralazine: oral tablet

Other dosage forms:

  • injection solution

Along with its needed effects, hydralazine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking hydralazine:

More common

  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • fast, pounding, or irregular heartbeat or pulse
  • nausea
  • shortness of breath
  • sweating

Less common

  • Black, tarry stools
  • blindness or vision changes
  • blisters on the skin
  • blurred vision
  • burning of the face or mouth
  • burning, crawling, itching, numbness, painful, prickling, “pins and needles”, or tingling feelings
  • chills
  • clumsiness or unsteadiness
  • confusion
  • cough
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fever and sore throat
  • general feeling of discomfort or illness or weakness
  • joint pain
  • lower back or side pain
  • muscle pain
  • numbness, tingling, pain, or weakness in the hands or feet
  • painful or difficult urination
  • pale skin
  • shakiness in the legs, arms, hands, or feet
  • skin rash or itching
  • swelling of the feet or lower legs
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • trembling or shaking of the hands or feet
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness in hands or feet

Rare

  • Dark urine
  • light-colored stools
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking hydralazine:

Symptoms of overdose

  • Feeling of warmth
  • headache
  • redness of the face, neck, arms, and occasionally, upper chest

Some side effects of hydralazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Diarrhea
  • loss of appetite
  • weight loss

Less common

  • Constipation
  • difficulty with moving
  • dizziness
  • feeling anxious or depressed
  • muscle cramps, pain, or stiffness
  • pain in the joints
  • rash, hives, welts, or itching
  • stuffy nose
  • watery eyes

For Healthcare Professionals

Applies to hydralazine: compounding powder, injectable solution, oral tablet

General

The most frequently reported side effects were palpitations and tachycardia.

Cardiovascular

Very common (10% or more): Palpitations, tachycardia

Common (1% to 10%): Angina pectoris, flushing, hypotension

Uncommon (0.1% to 1%): Heart failure, vasculitis

Very rare (less than 0.01%): Paradoxical pressor response

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, diarrhea, gastrointestinal disturbances

Very rare (less than 0.01%): Paralytic ileus

Frequency not reported: Constipation

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dizziness

Very rare (less than 0.01%): Peripheral neuritis, paresthesia, tremor, polyneuritis

Frequency not reported: Tingling, numbness

Musculoskeletal

Common (1% to 10%): Arthralgia, joint swelling, myalgia

Uncommon (0.1% to 1%): Systemic lupus erythematosus-like syndrome

Frequency not reported: Muscle cramp

Metabolic

Common (1% to 10%): Anorexia

Immunologic

Common (1% to 10%): Positive antinuclear factor

Respiratory

Uncommon (0.1% to 1%): Nasal congestion, dyspnea, pleural pain

Hematologic

Uncommon (0.1% to 1%): Anemia, leukopenia, neutropenia, thrombocytopenia

Very rare (less than 0.01%): Hemolytic anemia, leukocytosis, lymphadenopathy, pancytopenia, splenomegaly, agranulocytosis, eosinophilia

Frequency not reported: Blood dyscrasias, hemoglobin decreased, red cell count decreased

Renal

Uncommon (0.1% to 1%): Serum creatinine increased, glomerulonephritis

Very rare (less than 0.01%): Acute renal failure

Dermatologic

Uncommon (0.1% to 1%): Rash, purpura, urticaria, pruritus

Hepatic

Uncommon (0.1% to 1%): Jaundice, liver enlarged, abnormal liver function, hepatitis

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reaction

Genitourinary

Uncommon (0.1% to 1%): Proteinuria, hematuria, urinary retention

Very rare (less than 0.01%): Retroperitoneal fibrosis

Frequency not reported: Urination difficult

Ocular

Uncommon (0.1% to 1%): Lacrimation increased, conjunctivitis

Very rare (less than 0.01%): Exophthalmos

Other

Uncommon (0.1% to 1%): Edema, fever, weight decreased, malaise

Frequency not reported: Chills

Psychiatric

Uncommon (0.1% to 1%): Agitation, anxiety

Very rare (less than 0.01%): Depression, hallucinations

Frequency not reported: Psychotic reactions, disorientation, anxiety

1. “Product Information. HydrALAZINE Hydrochloride (hydrALAZINE).” Akorn Inc, Buffalo Grove, IL.

2. “Product Information. Apresoline (hydralazine).” Ciba Pharmaceuticals, Summit, NJ.

3. Cerner Multum, Inc. “Australian Product Information.” O 0

4. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

More about hydralazine

  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Patient Tips
  • Drug Images
  • Drug Interactions
  • Support Group
  • Pricing & Coupons
  • En Español
  • 54 Reviews
  • Drug class: vasodilators
  • FDA Alerts (1)

Consumer resources

  • Hydralazine
  • Hydralazine Tablets
  • Hydralazine Injection
  • Hydralazine Injection (Advanced Reading)
  • Hydralazine Oral, Injection, Intravenous (Advanced Reading)

Other brands: Apresoline

Professional resources

  • Hydralazine Hydrochloride (AHFS Monograph)
  • … +3 more

Related treatment guides

  • Hypertensive Emergency
  • High Blood Pressure
  • Heart Failure

About hydralazine

Type of medicine A vasodilator antihypertensive medicine
Used for The treatment of high blood pressure
Available as Tablets

Although many people with high blood pressure (hypertension) do not feel unwell, it is still important that high blood pressure be treated. If left untreated, high blood pressure is a risk factor that can increase your chance of developing heart disease, a stroke, and other serious conditions. Hydralazine will be prescribed alongside other medicines to control high blood pressure.

Hydralazine works by relaxing the muscles in the walls of your blood vessels. This means that your blood vessels widen, which reduces your blood pressure and allows blood and oxygen to circulate more freely around your body. Hydralazine will only be prescribed for you if other treatments are not suitable or effective, as it can increase the amount of water and salt in your body and can increase your heart rate. The other medicines you are prescribed to take alongside it will help to control these side-effects.

Hydralazine is occasionally prescribed by hospital doctors for other heart conditions. If you have been prescribed it for a reason other than high blood pressure, speak with your doctor if you have any questions about your treatment.

Before taking hydralazine

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking hydralazine it is important that your doctor knows:

  • If you have a condition called systemic lupus erythematosus. This is an inflammatory condition also called lupus, or SLE.
  • If you have any problems with the way your liver works, or if you have any problems with the way your kidneys work.
  • If you have a problem with your blood vessels, such as coronary artery disease or cerebrovascular disease.
  • if you have a heart condition or have recently had a heart attack.
  • If you are pregnant or breastfeeding.
  • If you have a rare inherited blood disorder called porphyria.
  • If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
  • If you have ever had an allergic reaction to any medicine.

How to take hydralazine

  • Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about hydralazine and will provide you with a full list of the side-effects which you could experience from taking the tablets.
  • Take hydralazine exactly as your doctor tells you to. It is usual to take one tablet twice a day. Try to take your doses at similar times of day each day, as this will help you to remember to take them regularly. There are two strengths of hydralazine tablet – it is usual to take the 25 mg strength tablet to begin with, but this may later be increased to the higher 50 mg strength tablet. Increasing your dose gradually allows your doctor to make sure that you have the dose that best helps your condition, but also keeps unwanted side-effects to a minimum.
  • Swallow the tablet whole with a drink of water. You can take hydralazine either with or without food.
  • If you forget to take a dose at your usual time, take it as soon as you remember unless your next dose is due. If your next dose is due then take the dose which is due but leave out the forgotten one. Do not take two doses together to make up for a missed dose.

Getting the most from your treatment

  • Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. You will need to have regular blood pressure measurements, and also some blood and urine tests from time to time.
  • Your doctor will advise you on what lifestyle changes you can make to help your condition. These could include losing weight if you are overweight, taking regular physical activity, eating a healthy diet, cutting back on the amount of alcohol you drink, stopping smoking, and reducing the amount of salt in your meals and caffeine in your drinks. It is important that you follow any advice you are given.
  • If you buy any medicines, check with a pharmacist that they are suitable for you to take. This is because some medicines (particularly some anti-inflammatory painkillers) can interfere with the way hydralazine works.
  • Treatment with hydralazine is usually long-term unless you experience an adverse effect. Continue to take the tablets unless you are advised otherwise by your doctor.
  • If you are having an operation or dental treatment, tell the person carrying out the treatment that you are taking hydralazine. This is because some anaesthetics can affect your blood pressure.

Can hydralazine cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the more common ones associated with hydralazine. The best place to find a full list of the side-effects which can be associated with your medicine, is from the manufacturer’s printed information leaflet supplied with the medicine. Alternatively, you can find an example of a manufacturer’s information leaflet in the reference section below. Speak with your doctor or pharmacist if any of the following continue or become troublesome.

Very common hydralazine side-effects (these affect more than 1 in 10 people) What can I do if I experience this?
Headache Drink plenty of water and ask your pharmacist to recommend a suitable painkiller. If the headaches continue, speak with your doctor
A fast heartbeat, the sensation of having a ‘thumping heart’ (palpitations) If you are concerned, speak with your doctor
Common hydralazine side-effects (these affect less than 1 in 10 people) What can I do if I experience this?
Feeling flushed, swollen feet or ankles, chest pain If any of these symptoms continue or cause you concern, speak with your doctor
Feeling dizzy If this happens, sit down for a while until you feel better. Do not drive and do not use tools or machines while affected. Do not drink alcohol
Feeling sick (nausea) or being sick (vomiting), diarrhoea Eat simple meals and drink plenty of water to replace lost fluids
Joint or muscle pain Speak with your doctor about this as soon as possible. It may be an early sign of systemic lupus erythematosus-like syndrome

If you experience any other symptoms which you think may be due to the tablets, please speak with your doctor or pharmacist for further advice.

How to store hydralazine

  • Keep all medicines out of the sight and reach of children.
  • Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

Do not keep-out-of date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

Apresoline

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/18/2019

Apresoline (hydralazine hydrochloride) is an antihypertensive drug indicated for treatment of hypertension by relaxing vascular smooth muscle. The brand name Apresoline is no longer available in the U.S. Generic versions may be available. Common side effects of Apresoline (hydralazine hydrochloride) include:

  • headache,
  • anorexia,
  • nausea,
  • vomiting,
  • loss of appetite,
  • diarrhea,
  • constipation,
  • dizziness,
  • pounding or fast heartbeat,
  • anxiety,
  • muscle or joint pain,
  • runny or stuffy nose, or
  • itching or skin rash.

The initial dose of Apresoline is 10 mg four times daily for the first 2-4 days, increased to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage of Apresoline to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels. Apresoline may interact with diazoxide or MAO inhibitors. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Apresoline; it may harm a fetus. Apresoline can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Apresoline Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HydrALAZINE, also known by the brand name Apresoline, is used to treat high blood pressure. HydrOXYzine, also known by the brand names such as Vistaril and Atarax, is used to treat symptoms of an allergic reaction, such as itching or a rash, but it is also used to treat nausea and anxiety.

Recently, a medication error was reported to us involving a 21-year-old man who was taken to the emergency department complaining of a headache, numbness in his arms and legs, and difficulty breathing. The man told the hospital staff his symptoms started after he took a new prescription medication for anxiety and insomnia. The man showed them the bottle of medicine which was labeled hydrALAZINE 25 mg (take 1-3 tablets every 6 hours). The physician, who suspected an error likely occurred, called the pharmacy to question the prescription. The pharmacy confirmed the mix-up. The pharmacy had indeed received a printed prescription for hydrOXYzine but in error filled it with hydrALAZINE. The man was eventually discharged from the emergency department with a new prescription hydrOXYzine.

In another case, a woman reported a medication error with her dog. The veterinarian prescribed hydrOXYzine for the dog. The pet’s owner administered the medicine for two days before noticing the drug information sheet indicated the medicine was for blood pressure. The consumer called the pharmacist who confirmed a mix-up did occur. The dog was actually dispensed hydrALAZINE instead of the prescribed hydrOXYzine.

Over the last 10 years ISMP has written about dispensing errors between these two medications. However, despite warnings and multiple recommendations to healthcare practitioners, we continue to receive reports of mix-ups between these two drugs. Contributing factors leading to these frequent mix-ups are:

• The first 4 letters of their names are identical
• They are frequently stored next to one another on pharmacy shelves
• They are listed alongside one another on computer screens
• They have similar dosage strengths (10, 25, 50 and 100 mg)

If you receive a prescription for either hydrALAZINE or hydrOXYzine, it is important to be on the lookout for potential mix-ups between these two drugs. When picking up your prescription always be sure to confirm you have the correct medication before leaving the pharmacy. Additionally, request your physician to include the reason for the medicine on your prescription. Knowing the medication’s purpose can help the pharmacist verify the prescriptions purpose with the proper drug.

WARNINGS

In a few patients hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydralazine should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests.)

PRECAUTIONS

General

Myocardial stimulation produced by Apresoline (hydralazine) can cause anginal attacks and ECG changes of myocardial ischemia. The drug has been implicated in the production of myocardial infarction. It must, therefore, be used with caution in patients with suspected coronary artery disease.

The “hyperdynamic” circulation caused by Apresoline (hydralazine) may accentuate specific cardiovascular inadequacies. For example, Apresoline (hydralazine) may increase pulmonary artery pressure in patients with mitral valvular disease. The drug may reduce the pressor responses to epinephrine. Postural hypotension may result from Apresoline (hydralazine) but is less common than with ganglionic blocking agents. It should be used with caution in patients with cerebral vascular accidents.

In hypertensive patients with normal kidneys who are treated with Apresoline (hydralazine) , there is evidence of increased renal blood flow and a maintenance of glomerular filtration rate. In some instances where control values were below normal, improved renal function has been noted after administration of Apresoline (hydralazine) . However, as with any antihypertensive agent, Apresoline (hydralazine) should be used with caution in patients with advanced renal damage.

Peripheral neuritis, evidenced by paresthesia, numbness, and tingling, has been observed. Published evidence suggests an antipyridoxine effect, and that pyridoxine should be added to the regimen if symptoms develop. The Apresoline (hydralazine) tablets (100 mg) contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who are also hypersensitive to aspirin.

Information for Patients

Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.

Laboratory Tests

Complete blood counts and antinuclear antibody titer determinations are indicated before and periodically during prolonged therapy with hydralazine even though the patient is asymptomatic. These studies are also indicated if the patient develops arthralgia, fever, chest pain, continued malaise, or other unexplained signs or symptoms.

A positive antinuclear antibody titer requires that the physician carefully weigh the implications of the test results against the benefits to be derived from antihypertensive therapy with hydralazine.

Blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, and purpura, have been reported. If such abnormalities develop, therapy should be discontinued.

Drug/Drug Interactions

MAO inhibitors should be used with caution in patients receiving hydralazine.

When other potent parental antihypertensive drugs, such as diazoxide, are used in combination with hydralazine, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide infection and Apresoline (hydralazine) are used concomitantly.

Drug/Food Interactions

Administration of hydralazine with food results in higher plasma levels.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a lifetime study in Swiss albino mice, there was a statistically significant increase in the incidence of lung tumors (adenomas and adenocarcinomas) of both male and female mice given hydralazine continuously in their drinking water at a dosage of about 250 mg/kg per day (about 80 times the maximum recommended human dose). In a P-year carcinogenicity study of rats given hydralazine by lavage at dose levels of 15, 30, and 60 mg/kg/day (approximately 5 to 20 times the recommended human daily dosage), microscopic examination of the liver revealed a small, but statistically significant, increase in benign neoplastic nodules in male and female rats from the high-dose group and in female rats from the intermediate-dose group. Benign interstitial cell tumors of the testes were also significantly increased in male rats from the high-dose group. The tumors observed are common in aged rats and a significantly increased incidence was not observed until 18 months of treatment. Hydralazine was shown to be mutagenic in bacterial systems (Gene Mutation and DNA Repair) and in one of two rat and one rabbit hepatocyte in vitro DNA repair studies. Additional in vim and in vitro studies using lymphoma cells, germinal cells, and fibroblasts from mice, bone marrow cells from Chinese hamsters and fibroblasts from human cell lines did not demonstrate any mutagenic potential for hydralazine.

The extent to which these findings indicate a risk to man is uncertain. While long-term clinical observation has not suggested that human cancer is associated with hydralazine use, epidemiologic studies have so far been insufficient to arrive at any conclusions.

Pregnancy Category C

Animal studies indicate that hydralazine is teratogenic in mice at 20 to 30 times the maximum daily human dose of 200 to 300 mg and possibly in rabbits at 10 to 15 times the maximum daily human dose, but that it is nonteratogenic in rats. Teratogenic effects observed were cleft palate and malformations of facial and cranial bones.

There are no adequate and well-controlled studies in pregnant women. Although clinical experience does not include any positive evidence of adverse effects on the human fetus, hydralazine should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

Nursing Mothers

Hydralazine has been shown to be excreted in breast milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established in controlled clinical trials, although there is experience with the use of Apresoline (hydralazine) in these patients. The usual recommended oral starting dosage is 0.75 mg/kg of body weight daily in four divided doses. Dosage may be increased gradually over the next 3-4 weeks to a maximum of 7.5 mg/kg or 200 mg daily.

SIDE EFFECTS: Headache, pounding/fast heartbeat, dizziness, loss of appetite, nausea, vomiting, diarrhea, or abdominal pain may occur as your body adjusts to the medication. You may also experience decreased sexual ability or increased sensitivity to the sun. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To reduce the risk of dizziness, get up slowly when rising from a sitting or lying position.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may infrequently cause nerve problems. Tell your doctor promptly if you experience numbness or tingling. Your doctor may recommend a vitamin B6 supplement (pyridoxine).Tell your doctor immediately if any of these unlikely but serious side effects occur: severe tiredness, aching/swollen joints, rash on nose and cheeks, swollen glands, change in the amount of urine, bloody/pink urine, dark urine, yellowing eyes/skin, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding.The hydrochlorothiazide in this product may cause a loss of too much body water (dehydration) or salt/minerals. Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or salt/mineral loss: very dry mouth, thirst, muscle cramps/weakness, irregular heartbeat, unusual drowsiness, unusual decrease in the amount of urine, fainting, confusion, seizures.Seek immediate medical attention if this rare but serious side effect occurs: chest/jaw/left arm pain.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to it; or to similar diuretics (such as chlorthalidone); or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: inability to make urine (anuria), a certain heart condition (coronary heart disease), a certain heart valve problem (rheumatic heart disease of the mitral valve).Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel problems, kidney problems, liver problems, asthma, diabetes, lupus, gout, previous stroke, salt/mineral imbalance (such as imbalance of sodium/potassium/calcium/magnesium levels in the body), loss of too much body water (dehydration).This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.This medication may reduce the potassium levels in your blood. Ask your doctor about increasing the amount of potassium in your diet or about using a salt substitute that contains potassium. Your doctor may prescribe a potassium supplement.If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.Before having surgery, tell your doctor or dentist that you are taking this medication.Older adults may be more sensitive to the side effects of this medication, especially dizziness.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.This medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

SLIDESHOW

Heart Disease: Causes of a Heart Attack See Slideshow

HYDRALAZINE TABLETS 25MG

Hydralazine
#25 mg
Tablets
Hydralazine
#25 mg
Tablets
Hydralazine
#25 mg
Tablets
5 055382 300298
Hydralazine
#25 mg
Tablets
Film-Coated
mg
56 Film-Coated Tablets
Oral use
Each film-coated tablet contains: 25 mg hydralazine hydrochloride.
Dosage: Oral use. Read the package leaflet before use.
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to
protect from light.
PL 4569/0050 LL0507AF 901902 A0029a/5
MA Holder: Mylan, Potters Bar,
POM Hertfordshire, EN6 1TL, U.K.
TBC
or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Hydralazine is and what it is used for
2. What you need to know before you take Hydralazine
3. How to take Hydralazine
4. Possible side effects
5. How to store Hydralazine
6. Contents of the pack and other information
3
1. What Hydralazine is and what it is used for
Hydralazine belongs to a group of medicines called
antihypertensives.
Hydralazine can be used along with other medicines:
• to reduce high blood pressure (hypertension)
• to treat moderate and serious heart failure.
• an increase in blood pressure • inflammation of the
nerves, which may causes tingling or numbness
especially in the hands, arms, feet or legs • painful
swelling in the arms or legs • swollen (lymph)
glands in the armpits, neck or groins • feeling
depressed • seeing, feeling or hearing things that
are not there (hallucinations) • abnormal swelling
of the spleen (splenomegaly). You may notice
signs such as being unable to eat a large meal,
feeling discomfort, fullness, or pain on the upper
left side of the abdomen; this pain may spread to
your left shoulder
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
17
Sunset
yellow (E110) which may cause allergic reactions in
some people.
3. How to take Hydralazine
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
If you are taking Hydralazine for a long time, your
doctor may wish to test your urine and blood every
six months.
Your doctor will start you on a low dose of Hydralazine
and gradually increase the dose depending on your
condition.
The recommended dose is:
Hydralazine Tablets 25
Film-Coated
TBC
1
20
Not all pack sizes may be marketed.
Marketing Authorisation Holder
56 Film-Coated Tablets
PL 4569/0050 LL0507AF 901902 A0029a/5
MA Holder: Mylan, Potters Bar,
POM Hertfordshire, EN6 1TL, U.K.
ethylcellulose, carnauba wax, red iron oxide (E172),
hypromellose, titanium dioxide (E171) and Quinoline
yellow (E104).
glass or plastic containers and blisters of 5, 7, 10, 14,
15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112,
mg
Oral use
Each film-coated tablet contains: 25 mg hydralazine hydrochloride.
Dosage: Oral use. Read the package leaflet before use.
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to
protect from light.
away medicines you no longer use. These measures
will help to protect the environment.
6. Contents of the pack and other information
What Hydralazine contains
The active substance is hydralazine hydrochloride.
titanium dioxide (E171), lactose (see section 2
“Hydralazine contains lactose”), hypromellose,
macrogol, indigo carmine (E132), sunset yellow (E110)
hydrochloride.
(E110)”) iron oxide yellow (E172) and erythrosine
(E127).
What Hydralazine looks like and contents of
the pack
hydrochloride.
The other ingredients are microcrystalline cellulose,
pregelatinised maize starch, colloidal anhydrous silica,
disodium edetate, talc and magnesium stearate.
“HE 25” on one side and “G” on the reverse.
Manufacturer
Generics Limited, Potters Bar, Hertfordshire,
contains diethyl phthalate, hydroxypropylcellulose,
Grange Road, Dublin 13, Ireland.
21
Anti-hypertensives work by lowering blood pressure.
High blood pressure increases the workload of the
heart and arteries (blood vessels) and if left untreated,
can lead to damage of the blood vessels of the brain,
heart and kidneys.
Other medicines and Hydralazine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines
including medicines obtained without a prescription,
herbal medicines or any of the following:
• other antihypertensives including medicines
used to widen the blood vessels such as diazoxide
or nitrates, beta-blockers (e.g. propranolol), ACE
inhibitors (e.g. captopril), “water” tablets (diuretics
e.g. furosemide ) and medicines known as “calcium
channel blockers” (e.g. verapamil) • medicines used
to treat depression e.g. tricyclic antidepressants
such as dosulepin, monoamine oxidase inhibitors
(MAOIs) such as phenelzine or to treat a mental
illness (eg. Chlorpromazine) • medicines used to
treat anxiety such as tranquillisers (e.g. diazepam)
bruising or bleeding of the skin (reduced number
of platelets), frequent infections, fever, chills, sore
throat or mouth ulcers (reduced number of white
blood cells) • liver problems, which can cause
yellowing of the skin or whites of the eyes, dark
urine and pale stools • blood in the urine (the
urine may look red or pink)
Very rare
• illness resulting from the destruction of red blood
cells with signs such as looking pale, feeling tired,
breathlessness, yellowing of the skin and/or eyes
• a reduction in all types of blood cells, which
may cause frequent infections, unusual bruising
or bleeding of the skin or you to feel tired and
breathless • changes in how much you urinate,
9
2. What you need to know before you take
Hydralazine
Do not take Hydralazine:
• if you are allergic to hydralazine hydrochloride or
dihydralazine, or any of the other ingredients of this
medicine (listed in section 6) • if you suffer from
the condition systemic lupus erythematosus
(SLE) or a related disease • if you suffer from an
unusually fast heart beat • if you have heart failure,
heart valve problems (aortic or mitral stenosis)
6
• anti-inflammatory painkillers (NSAIDs) e.g.
indometacin • corticosteroids e.g. prednisolone •
medicines which slow down the nervous system
(CNS depressants) • carbenoxolone, used to
treat stomach ulcers • anaesthetics • medicines
containing oestrogens e.g. HRT, or the combined
oral contraceptive pill.
Ask your doctor or pharmacist for advice before taking
any medicine.
Hydralazine with alcohol
Alcohol may increase the effects of hydralazine
causing side effects such as dizziness.
Pregnancy and breast-feeding
Hydralazine should only be used in the last few
months of pregnancy
test • increased levels of creatinine in the blood
which would be seen in a blood test • loss of
appetite, weight loss • feeling generally unwell •
feeling anxious or agitated • itchy, red, infected
eyes (conjunctivitis), watery or swollen eyes. •
abdominal swelling caused by enlarged liver or
fluid retention in the body • swelling of blood
vessels. Signs include fever, general aches and
pain, loss of appetite, weight loss and tiredness
• pinkish, itchy swellings on the skin, also called
hives or nettle rash • increase in some white blood
cells which may be seen in a blood test • decrease
in some red blood cells which may be seen in a
blood test
Very rare
REVISED ARTWORK FOR MHRA APPROVAL
DRAFT ISSUE: 3
REASON FOR CHANGE: Change to braille & cutter
SUPPLIER ISSUE DATE: 20.9.2016
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This leaflet was last revised in 08/2016.
Package leaflet: Information for the patient
HYDRALAZINE 25 mg FILM-COATED TABLETS
HYDRALAZINE 50 mg FILM-COATED TABLETS
(hydralazine hydrochloride)
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist. • This medicine has been prescribed
for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as
yours. • If you get any side effects, talk to your doctor
or inflammation of the heart (constrictive
pericarditis) • if you have an aortic aneurysm
(swelling in the wall of the aorta which can cause
sweating, a fast heartbeat, and abdominal or back
pain) • if you have an enlarged heart often caused
by lung disease (cor pulmonale) • if there is a
family history of the rare condition porphyria.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Hydralazine:
• if you have liver or kidney problems. • if you suffer
from hardened arteries (coronary artery disease),
chest pain (angina) or are at risk of having a
stroke. • if you are recovering from a heart attack. •
if you need surgery.
listed in this leaflet.
You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
difficulty or pain when passing urine, lower back
pain, fever, nausea and vomiting – these may
be signs of kidney problems • severe pain in the
stomach with bloating, cramps, constipation and
vomiting • protruding eyes
Other possible side effects
Very common
• fast or irregular heart beat • headache
Common
• low blood pressure • muscle or joint pain • swelling
of the joints • feeling or being sick • diarrhoea,
upset stomach • chest pain • flushing • dizziness •
blocked nose
Rare
• protein in the urine which would be seen in a urine
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
Do not drive or use machines if you suffer from
headaches or have difficulty concentrating while
taking this medicine. Speak to your doctor or
pharmacist for advice.
Hydralazine contains lactose
lactose. If you
have been told by your doctor that you have an
intolerance to some sugars, such as lactose, contact
your doctor before taking this medicine.
Hydralazine contains Sunset yellow (E110)
should carry on taking your medicine as long as your
doctor or pharmacist tells you to, even if you feel
better.
Use in children and adolescents
Hydralazine should not be given to children or
adolescents.
Method of administration
Swallow the tablets with a glass of water.
If you take more Hydralazine than you should
The signs and symptoms of hydralazine overdose
include low blood pressure, a racing heart beat,
headache and generalised skin flushing. If you
take more Hydralazine than you should contact
your doctor or hospital emergency department
immediately.
If you forget to take Hydralazine
If you forget to take a dose of Hydralazine take it as
soon as you remember unless it is nearly time for your
next dose. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Hydralazine
Do not stop taking Hydralazine without talking to
your doctor, even if you feel better, because it may
make your illness worse.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
5
18
5. How to store Hydralazine
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the label or container after “EXP”. The expiry
date refers to the last day of that month.
Do not store above 25°C. Store in the original package
in order to protect from light.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
8
15
see your doctor straight away or go to the nearest
hospital immediately.
Common
people)
• systemic lupus erythematosus (SLE) or a related
disease with signs such as joint pain (similar to
rheumatoid arthritis), fever, change in blood count
and skin rash
Rare
• swelling of the hands and lower legs, breathlessness,
tightness of the chest, sharp chest pain which is worse
when breathing in, feeling dizzy • allergic reactions
such as itchy red and swollen skin, red skin rash
on cheeks and other parts of the body, skin rashes
which may be severe • signs of reduced numbers
of different blood cells, which may cause unusual
10
Adults
Hypertension
Hydralazine twice a day, increasing to a maximum
Heart failure
of Hydralazine three or four times a day; if necessary,
day.
A small group of patients can break down hydralazine
in their body at a different rate to the majority of
patients. This can lead to unwanted effects. Your
doctor will check for this possibility, and if this occurs,
will change your dose of Hydralazine as needed. You
13
VERSION: 5 (MYLAN)
4
19
2
“HE 50” on one side and “G” on the reverse.
Almus ® is a registered trademark
PEEL HERE BUT DO NOT REMOVE
Hydralazine Tablets 25
Almus ® is a registered trademark
PEEL HERE BUT DO NOT REMOVE
22
DIMENSIONS 52 x 101mm
BARCODE 5055382300298
PHARMA CODE TBC
ALMUS CODE A0029a/5
SUPPLIER CODE LL0507AF
SUPPLIER CODE 901902
4. Possible side effects
Like all medicines, Hydralazine can cause side effects,
although not everybody gets them. If any of the
following happen, stop taking this medicine and
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Client:
Almus UK
Project:
10563 / UK
Hydralazine Tablets
25mg x 56
Item(s):
Colours used:
BLACK
PMS
349
PMS
1788
PMS
142
Label Leaflet
Checked by: Paul Adams
KEYLINE
This scale measures 100mm when artwork is 100%
0
10
20
30
Queries regarding this artwork,
please contact: Steve Hobbs or
Paul Adams
BRAILLE
Date: 20.9.2016
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100
pmdc design llp
Lower Test Studios
Sheardley Lane, Droxford
Hampshire SO32 3QY
+44 (0)1489 878780

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