- What is Plaquenil?
- Important information
- Before taking this medicine
- How should I take Plaquenil?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking Plaquenil?
- Plaquenil side effects
- What other drugs will affect Plaquenil?
- Further information
- More about Plaquenil (hydroxychloroquine)
- April & May’s Topic of the Month – Coping with Side Effects
- How does this medication work? What will it do for me?
- What form(s) does this medication come in?
- How should I use this medication?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
- Leflunomide‐associated weight loss in rheumatoid arthritis
- CASE REPORTS
- Lupus Medications
Generic Name: hydroxychloroquine (hye drox ee KLOR oh kwin)
Brand Names: Plaquenil, Quineprox
Medically reviewed by Sanjai Sinha, MD Last updated on Apr 10, 2019.
- Side Effects
What is Plaquenil?
Plaquenil (hydroxychloroquine) belongs to a group of medicines called quinolines.
Plaquenil is used to treat or prevent malaria, a disease caused by parasites that enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia. This medicine is not effective against all strains of malaria.
Plaquenil is also an antirheumatic medicine and is used to treat symptoms of rheumatoid arthritis and discoid or systemic lupus erythematosus.
Taking Plaquenil long-term or at high doses may cause irreversible damage to the retina of your eye. Stop taking Plaquenil and call your doctor at once if you have trouble focusing, if you see light streaks or flashes in your vision, or if you notice any swelling or color changes in your eyes.
Before using Plaquenil, tell your doctor if you are allergic to any drugs, or if you have psoriasis, porphyria, liver disease, alcoholism, or glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
Take Plaquenil for the full prescribed length of time for malaria. Your symptoms may improve before the infection is completely cleared.
When treating lupus or arthritis, tell your doctor if your symptoms do not improve after 6 months of treatment.
Before taking this medicine
You should not use Plaquenil if you are allergic to hydroxychloroquine.
Plaquenil should not be used for long-term treatment in children.
To make sure Plaquenil is safe for you, tell your doctor if you have:
a history of vision changes or damage to your retina caused by an anti-malaria medication;
heart disease, heart rhythm disorder (such as long QT syndrome);
a stomach disorder;
an allergy to quinine;
liver or kidney disease;
a genetic enzyme disorder such as porphyria or glucose-6-phosphate dehydrogenase (G6PD) deficiency.
It is not known whether Plaquenil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Malaria is more likely to cause death in a pregnant woman. If you are pregnant, talk with your doctor about the risks of traveling to areas where malaria is common.
It is not known whether hydroxychloroquine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Plaquenil is not approved for use by anyone younger than 18 years old.
How should I take Plaquenil?
Take Plaquenil exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Plaquenil is sometimes given only once per week. Choose the same day each week to take this medicine if you are on a weekly dosing schedule.
Take Plaquenil with a meal or a glass of milk.
To prevent malaria: Start taking Plaquenil 2 weeks before entering an area where malaria is common. Continue taking the medicine regularly during your stay and for at least 8 weeks after you leave the area.
To treat malaria: Plaquenil is usually given for 3 days, starting with one high dose followed by a smaller dose during the next 2 days in a row.
Take Plaquenil for the full prescribed length of time for malaria. Your symptoms may improve before the infection is completely cleared.
Use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.
Call your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.
No medication is 100% effective in treating or preventing all types of malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.
When treating lupus or arthritis, Plaquenil is usually given daily for several weeks or months. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 months of treatment.
While using Plaquenil, you may need frequent blood tests and vision exams.
Store at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydroxychloroquine can be fatal, especially in children.
Plaquenil overdose must be treated quickly. You may be told to induce vomiting right away (at home, before transport to an emergency room). Ask the poison control center how to induce vomiting in the case of an overdose.
Overdose symptoms may include drowsiness, vision changes, slow heart rate, chest pain, severe dizziness, seizure (convulsions), or shallow breathing.
What should I avoid while taking Plaquenil?
Avoid taking an antacid or Kaopectate (kaolin-pectin) within 4 hours before or after you take hydroxychloroquine. Some antacids can make it harder for your body to absorb hydroxychloroquine.
Plaquenil side effects
Get emergency medical help if you have signs of an allergic reaction to Plaquenil: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Taking Plaquenil long-term or at high doses may cause irreversible damage to the retina of your eye. Stop taking Plaquenil and call your doctor at once if you have trouble focusing, if you see light streaks or flashes in your vision, or if you notice any swelling or color changes in your eyes.
Call your doctor at once if you have:
headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
very slow heart rate, weak pulse;
muscle weakness, numbness or tingling;
low blood sugar – headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky; or
low blood cell counts – fever, chills, sore throat, weakness or ill feeling, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed.
Common Plaquenil side effects may include:
headache, dizziness, ringing in your ears;
nausea, vomiting, stomach pain;
loss of appetite, weight loss;
mood changes, feeling nervous or irritable;
skin rash or itching; or
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.
What other drugs will affect Plaquenil?
Plaquenil can cause serious liver or heart problems, especially if you use certain medicines at the same time, including:
other medicines to treat malaria;
an antibiotic or antifungal medicine;
antiviral medicine to treat hepatitis or HIV/AIDS;
antidepressants or antipsychotic medicines;
birth control pills or hormone replacement therapy;
heart or blood pressure medicine;
pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve);
stomach acid reducers; or
This list is not complete and many other drugs can interact with hydroxychloroquine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Plaquenil. Give a list of all your medicines to any healthcare provider who treats you.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Plaquenil only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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April & May’s Topic of the Month – Coping with Side Effects
Side effects are unwanted symptoms caused by medical treatment. They’re also called “adverse effects” or “adverse reactions”. All medicines can cause side effects, particularly if they are not used as advised. This includes prescription medicines, medicines you can buy over the counter, and herbal remedies and supplements.
How likely am I to experience side effects from my medication?
It is very important to understand that your treatment can potentially cause side effects and to understand what they may be. Side effects can range from mild, such as drowsiness or feeling sick (nausea), to severe, such as life-threatening conditions, although these are rare. The risk of getting side effects varies from person to person.
The Patient Information Leaflet (PIL) supplied with your medicine will list its known side effects. If you no longer have your medicine’s PIL, you can find a copy on the electronic Medicines Compendium (eMC).
The PIL will show whether each side effect is:
- Very common: more than 1 in 10 people are affected
- Common: between 1 in 10 and 1 in 100 people are affected
- Uncommon: between 1 in 100 and 1 in 1,000 people are affected
- Rare: between 1 in 1,000 and 1 in 10,000 people are affected
- Very rare: fewer than 1 in 10,000 people are affected
When doctors prescribe medications they weigh the risk of potential side effects against the benefit that the medicine can provide. For example, if you develop pneumonia (infection of the lungs) and your doctor prescribes penicillin for your infection, you may read on the PIL that one of the potential side effects from the medicine is severe allergic reaction. Many people are allergic to penicillin and learn over their lifetime to never take it if they have had an allergic reaction, but the vast majority of those allergic reactions are not life-threatening. The important consideration is that the chance of dying or developing permanent body damage from an infection such as pneumonia is far greater than the chances of developing these severe side effects. In other words, the benefit of taking the antibiotic outweighs the potential side effects.
Today, new medications that are approved for use are studied far more extensively than at any other time in history. When a drug first comes on the market, you can be assured that it has been studied in more people and more intensely by doctors and scientists than older medications were. Medicines also continue to be carefully regulated after they’ve been licensed. This involves checking for problems and logging previously unknown side effects.
“It’s hard not to panic when you experience some side effects, but with some you have to stick with it and see if it settles down (unless you feel really awful, in which case a trip to the docs is in order). Resting also helps, and I never start a new med without support being in the house (my partner).”
Are there any side effects of lupus treatments I need to be aware of?
There are a very wide range of drugs used in the management of lupus. It is therefore not possible to cover everything in this article, but below we have highlighted a few important side effects from some of the medications most commonly prescribed for people with lupus;
Hydroxychloroquine is an antimalarial medication which is prescribed for most people with lupus as well as a number of other connective tissue diseases. It has a number of properties which make it useful in treating lupus and is widely considered one of (if not THE) safest treatment for the condition.
One of the most discussed side effects of this treatment is retinopathy, which can cause blurred vision, difficulty reading, intolerance of bright light, and sometimes episodes of flashes of light. Studies suggest that it probably occurs in around 1% to 7% of people who have taken the drug for more than five years and most cases resolve after stopping the medication. To reduce the risk of permanent impairment to vision people taking hydroxychloroquine are advised to have their eyes checked annually, including tests that are very sensitive for retina problems. You can get more information about the tests HERE.
Some people may experience adverse effects such as gastrointestinal upset, nausea or general ‘flare’ symptoms when they have hydroxychloroquine tablets produced by certain manufacturers. We are aware of a lot of anecdotal evidence from people with lupus who experience adverse effects from Quinoric® branded hydroxychloroquine tablets. This is not the experience of everyone, but if you would like to read more about this and how to potentially resolve the problem, please read our page HERE.
“It is important to have an eye test to check that your retina is healthy prior to starting hydroxychloroquine and to have an annual eye test whilst taking the tablets. When I started taking them, I experienced abdominal discomfort, diarrhoea and flatulence but please be reassured this will pass after about a month. Depending on what brand you are prescribed, some can be very bitter and I always take mine with yogurt; this helps to reduce bitterness.”
Non-steroidal anti-inflammatory drugs (NSAIDs)
These are the standard drugs used for joint pains such as ibuprofen or naproxen. Unfortunately these drugs are prone to cause indigestion. They may cause peptic ulcers and bleeding from the gut and may increase the risk of heart attacks and stroke if taken regularly for long periods of time (e.g. years).
Corticosteroids (e.g. prednisolone)
Steroids are potentially life-saving drugs for moderate and severe lupus but modern treatment is geared to reduce the dose as soon as possible so that patients can be maintained on a low dose or weaned off altogether. The side effects of high dose steroids long-term are well known and include weight gain and “moon” face, diabetes, infections, raised cholesterol, muscle weakness and bone softening (osteoporosis).
“I’ve taken very high doses of prednisolone. It is important to eat a healthy diet and check weight weekly. I found cutting down on salt and sugar helped to maintain my weight. It is wise to check blood pressure at least monthly and ensure the GP checks blood sugar levels too.”
Immunosuppressants (such as azathioprine, methotrexate, mycophenolate mofetil and cyclophosphamide)
These drugs are used to reduce the need for steroids to control moderate and severe lupus.
With the exception of azathioprine, none of these treatments are safe to use during pregnancy (due to risk of congenital abnormalities) or breast-feeding. You can read more about this in our booklet, ‘LUPUS: A Guide to Pregnancy’, HERE.
These treatments can possibly cause a reduction in your white blood cell count and increase risk of infections. You will usually have regular blood tests whilst on these treatments to monitor your white blood cell count and check for any toxicity caused by the drugs.
Cyclophosphamide also carries a risk of causing failure to the ovaries or sperm-producing cells, making patients infertile (unable to have children). Your consultant would outline this risk before beginning treatment to discuss the possibility of freezing ova or sperm if you wish.
Biologic infusions (such as rituximab and belimumab)
These drugs have been developed to target certain pathways in the immune system that are associated with inflammation and active lupus.
It is currently advised not to use these treatments during pregnancy or breastfeeding because their safety hasn’t been sufficiently investigated.
Whilst the drug is being administered into the vein, you may experience an ‘infusion reaction’. If this occurs you may notice that you start to shiver, develop a rash, start to wheeze, or develop swelling of the lips. It is not possible to predict who will experience this side effect. If these symptoms occur, then tell the nurse/doctor immediately. The infusion will be temporarily stopped and when your symptoms have settled, the treatment can usually be restarted at a slower rate.
How do I know if I am experiencing medication side effects, or if it is symptoms of lupus?
It can sometimes be difficult to tell whether a symptom you are experiencing is caused by a medication you are taking, by lupus, or by an associated condition. Due to the varied nature of lupus and the many symptoms it can potentially cause, there is often an overlap with the side effects listed on the PILs provided with your medication.
“It can sometimes be hard to know if it’s the drug, illness or infection causing problems.”
Some ways that you can possibly help to distinguish lupus symptoms from medication side effects is to consider;
- Have you recently started a new medication or changed the dose?
- Have you recently been exposed to any triggers that could cause your lupus to flare (such as UV light, stress or a viral infection)?
- Have any of your other lupus symptoms also flared-up when this new one developed?
It is generally best to make your doctor aware of any new symptoms or side effects that you may be experiencing, whether they may be caused by your medication or the condition.
You may wish to chat to other people with lupus who are on the same medication to see if they have had any similar experiences. A great place to do this is the LUPUS UK HealthUnlocked Community Forum. You can read more about the forum and how to join HERE. It is important to remember that everyone with lupus is different and the experiences of others may not reflect yours. Chatting with other members of the forum is not a substitute for advice from your medical team.
What should I do if I think I’m experiencing side effects from my treatment?
If you think that you may be having a serious allergic reaction to a medicine, phone 999 and ask for immediate medical help.
You should contact your GP or pharmacist immediately if:
- you think you have a side effect that is listed as severe in your medicine’s patient information leaflet (PIL).
- you have a side effect you think is serious.
If you ever get a side effect to a medicine, it is important to let your doctor know so that they can give you instructions on whether it is safe to continue taking the medicine or not. It is best not to determine how mild a side effect of a medicine is on your own. It is always better to contact your doctor for advice instead.
Never stop a medicine or change your dosage without your doctor’s approval. You need to take some medicines, like antibiotics, for a full course to avoid getting sick again. Others don’t work as well if you skip a dose, cut it in half, or take it with or without food. It can also be dangerous to stop certain treatments (such as steroids) suddenly.
When you talk to your doctor, have a list of all other medications or supplements you’re taking — both prescription and over-the-counter. Sometimes, side effects are caused by two or more drugs reacting negatively together. The LUPUS UK Progress Diary (which you can order HERE) includes pages to fill in your medication list. You can alternatively download and print these pages separately HERE. There are also a range of smartphone apps that have this feature – you can find examples of these in our article HERE.
“My tip for coping with drug side effects is talk to your GP about any concerns you have as a lot of pills can be changed or doses adjusted to help mitigate them! It’s a juggle of risk versus benefit for us all the time.”
“I always check with the pharmacist when I get a new prescription. I’d recommend going through all meds with a pharmacist every now and again, especially if you have quite a few, as that helped me get rid of stomach aches. Apparently I was taking things at the wrong time and some meds were interacting together and these meds were given to me by nurses at hospital!”
Some side effects go away over time as your body gets used to a new drug, so your doctor may recommend you stick with your current plan for a little longer. In other cases, you may be able to lower your dose, try a different drug, or add another one, like an anti-nausea medicine, to your routine.
“Methotrexate was not the medication for me! It is a good medication for many with lupus but it has made my symptoms worse! After an in-depth discussion with my rheumatologist it was agreed that the medication must be stopped. I’m awaiting another consultation with the doctor and other immunosuppressive drugs are being considered.”
Yellow Card Scheme
You can help the Medicines and Healthcare Regulatory Agency (MHRA) to monitor the safety of medicines by reporting any suspected side effects you experience to the Yellow Card Scheme. Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, and all medical devices available on the UK market.
It is important for people to report problems experienced with medicines or medical devices as these are used to identify issues which might not have been previously known about. The MHRA will review the product if necessary, and take action to minimise risk and maximise benefit to the patients.
To learn more about the Yellow Card Scheme or to report a suspected side effect you have experienced, go to https://yellowcard.mhra.gov.uk/
Is there anything I can do to self-manage some of the side effects I experience?
Some medication side effects can potentially be avoided or relieved by things you can do yourself. Examples include;
Knowing how to take your medication(s) correctly
Some medications are best taken without food; some are better taken with food for better absorption. Some medicines should not be taken at the same time as other medicines. These instructions will often be included in the patient information leaflet provided with the medication. If you are taking lots of medications then it can be a helpful exercise to review this with your pharmacist and get their advice about the best way to take them all.
“I used to take mine all together but always ended up with stomach and sickness issues. I’ve now learnt to take half in the morning and the others in the evening. I also make sure I take them all after food.”
Making lifestyle changes
You may be able to prevent some side effects by avoiding alcohol or certain foods, or by making other small changes to your diet or lifestyle. Your doctor and/or the PIL will usually tell you if you need to avoid/limit any substances, including alcohol, for the duration of the treatment. If you are taking a medication which causes you to gain weight, you may have to pay more attention to your nutrition and exercise plan. You may have to add a supplement to reduce the risk of some side effects, such as taking calcium and vitamin D to reduce the risk of osteoporosis if you are on steroids.
Grapefruit juice affects how some medicines (such as cholesterol drugs and blood thinners) are changed (metabolised) in the body for eventual elimination, and can alter the amount of drug in your blood. Therefore, you may need to avoid grapefruit if you are taking one of these treatments. Read more about this and find which drugs are affected HERE.
“I am taking methotrexate and it started to make my skin flake. Nothing was working; I switched my body wash/lotion and nothing helped. I asked my mum and she said the only thing that helped for her (while going through chemo) was a product called Rainbath by Neutrogena. So I tried that, paired with the body oil and bam! It’s been working! No more flaky dry skin!”
Coping with nausea (sickness)
Try to eat small meals more often or suck on hard sweets. Staying hydrated is important and can also help. Herbal teas with peppermint, ginger or liquorice can help settle your stomach and may help with feelings of nausea.
Lots of advice for coping with nausea can be found HERE.
“I take my medication at night so I don’t experience the nausea.”
Coping with insomnia
Some treatments may affect your sleep pattern. Practicing good sleep hygiene such as avoiding caffeine and not looking at screens late at night may help towards returning to a normal routine. For more tips on sleep hygiene go HERE.
“My tip for steroids is taking them at breakfast as they are less likely to give you insomnia.”
Overcoming sexual dysfunction
Side effects such as sexual dysfunction tend to be temporary but can be distressing. Creative approaches to sexual intimacy can help you enjoy yourself and stay connected with your partner even while you continue your treatment. Consider sex therapy as a way to get some new ideas for sex. Learn more HERE.
Coping with hair loss
For information and advice about coping with hair loss, please take a look at our article HERE.
LUPUS and Medication
LUPUS UK’s Factsheet about the treatments used in the management of lupus.
electronic Medicines Compendium (eMC)
Up to date, approved and regulated prescribing and patient information for licensed medicines –
NHS Choices – What are Side Effects?
Arthritis Research UK – Drugs
Patient information about various drugs used in the management of arthritis and other musculoskeletal conditions
Find your local Pharmacist
Find local health services such as pharmacists using the NHS website.
***Please note that this article is written for informational purposes only and should not be a substitute for professional medical advice or treatment. Do not delay seeking or disregard medical advice based on information here. Always seek the advice of your local family physician or other qualified health professional before starting any new treatment or making any changes to existing treatment. It is also advisable to consult a medical professional before making any changes to diet or starting complementary remedies, which may interact with other medications.***
Thank you so much to everyone who submitted their tips and experiences for this month’s topic. We’re sorry if we weren’t able to use your comment in the article this time.
How does this medication work? What will it do for me?
Hydroxychloroquine belongs to a group of medications known as anti-inflammatories and antimalarials. It is used alone or in combination with other anti-arthritic medications to treat rheumatoid arthritis. It helps to reduce pain, stiffness, and swelling in joints. It may take several weeks before the beneficial effects of hydroxychloroquine for the treatment of rheumatoid arthritis are seen.
Hydroxychloroquine is also used to treat and prevent certain types of malaria. It may also be used for the treatment of lupus.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each white-to-off-white, film-coated, peanut-shaped tablet with “PLAQUENIL” in black on one side contains 200 mg of hydroxychloroquine sulfate (equivalent to 155 mg of base). Nonmedicinal ingredients: black ink, calcium hydrogenophosphate, carnauba wax, corn starch, magnesium stearate, opadry White YS-I-7443, and polyethylene glycol 400.
How should I use this medication?
Recommended doses of the medication vary according to the condition being treated.
Rheumatoid arthritis: The usual adult starting dose is 400 mg to 600 mg daily. It may take several weeks before the beneficial effects of hydroxychloroquine for the treatment of rheumatoid arthritis are seen, and several months before maximum effects are achieved. After 5 to 10 days, the dose may be gradually increased. After a good response to treatment is seen (usually within 4 to 12 weeks), the dose is decreased to 200 mg to 400 mg daily.
Lupus: The usual starting dose for adults is 400 mg once or twice daily. This dose may be continued for several weeks or months depending on the benefits that occur. For long-term use, the dose of hydroxychloroquine is usually reduced to 200 mg to 400 mg daily.
Malaria: The recommended preventative adult dose is 400 mg on exactly the same day of each week, beginning 2 weeks before exposure and continued for 8 weeks after leaving the high-risk area. Children’s doses are based on body weight and are calculated as 5 mg of hydroxychloroquine base per kilogram of body weight to a maximum dose of 400 mg.
For treatment of acute attacks of malaria, the recommended starting dose for adults is 800 mg followed by 400 mg after 6 to 8 hours. This is followed by 400 mg on each of the next 2 days for a total of 2,000 mg of hydroxychloroquine. Some doctors may decide to prescribe a single dose of 800 mg only, as this method has also been found effective in the treatment of malaria. Children’s doses are based on body weight as prescribed by the doctor.
To help reduce stomach upset, hydroxychloroquine should be taken with a meal or a glass of milk.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is within 12 hours of your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep this medication out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take hydroxychloroquine if you:
- are allergic to hydroxychloroquine or any ingredients of the medication
- are allergic to any of the 4-aminoquinoline compounds, such as chloroquine
- have been previously diagnosed with retinopathy of the eye
Do not give this medication to children under 6 years of age.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- hair loss
- increased skin sensitivity to sunlight
- loss of appetite
- skin rash
- stomach cramps or pain
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- blurred vision or any change in vision – this effect may also occur or worsen after stopping the medication
- change in colour of hair or skin pigment
- flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
- hallucinations (seeing or hearing things that are not there)
- mood or other mental changes
- muscle weakness
- ringing or buzzing in ears or any loss of hearing
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
- signs of heart problems (e.g., fast, irregular heartbeat or pulse, chest pain, sudden weight gain, difficulty breathing, leg swelling)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- signs of low blood sugar (hypoglycemia) (e.g., blurred vision, dizziness, fatigue, headache, numbness or tingling of the mouth, rapid heartbeat, shakiness, sweating or confusion)
- tingling, numbness or burning pain
- unusual tiredness or weakness
Stop taking the medication and seek immediate medical attention if any of the following occur:
- convulsions (seizures)
- extrapyramidal symptoms (abnormal body movements, restlessness, shaking, or stiffness)
- signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- thoughts of suicide or self-harm
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Blood tests: If you take this medication for a long period of time, your doctor will likely want you to have blood tests to monitor your levels of red and white blood cells.
Blood sugar levels: Hydroxychloroquine may cause hypoglycemia (low blood sugar levels). People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication. People without diabetes have also been known to experience low blood sugars while taking hydroxychloroquine. If you experience signs of low blood sugar (cold sweat, cool pale skin, headache, or weakness), contact your doctor immediately.
Blurred vision: While taking this medication, use caution when driving or operating machinery, since hydroxychloroquine can cause blurring of vision. If your vision blurs, call your doctor.
Eye damage: Irreversible damage to the retina of the eye has occurred for some people who take long-term or high-dosage treatment with hydroxychloroquine. Eye damage is more likely to occur if recommended doses are exceeded. Your doctor will want you to have regular eye exams if you take this medication for a period of time. If you notice any new problems with sight or symptoms such as light flashes and streaks, stop the medication at once and call your doctor.
Heart disease: Rarely, weakening of the heart muscle has been reported with the use of hydroxychloroquine. If you have heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney disease: If you have kidney disease, you may need a lower dose of this medication. Talk to your doctor about how this medication may affect your medical condition, how the medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver disease: If you have liver disease, you may need a lower dose of this medication. Talk to your doctor about how this medication may affect your medical condition, how the medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Muscle weakness: Call your doctor if you notice any signs of unusual or unexpected muscular weakness.
Other medical conditions: If you have stomach, nerve, blood, or skin disorders, talk to your doctor about how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Suicidal behaviour: Rarely, people taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.
Pregnancy: Hydroxychloroquine crosses the placenta during pregnancy and may cause harm to the developing baby if it is taken by the mother during pregnancy. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes in small amounts into breast milk. Infants are extremely sensitive to its side effects. If you are a breast-feeding mother and are taking hydroxychloroquine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children when used for the treatment of rheumatoid arthritis or systemic lupus erythematosus. Children are especially sensitive to the side effects of hydroxychloroquine.
What other drugs could interact with this medication?
There may be an interaction between hydroxychloroquine and any of the following:
- beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
- diabetes medications (e.g., glyburide, chlorpropamide, insulin, rosiglitazone)
- live vaccines (e.g., BCG, yellow fever, measles, mumps, rubella)
- pyrantel pamoate
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Plaquenil
Leflunomide‐associated weight loss in rheumatoid arthritis
Patient 1 is a 77‐year‐old man whose seropositive RA has persisted for >30 years. Prior treatment with disease‐modifying antirheumatic drugs (DMARDs) included gold salts, methotrexate, azathioprine, hydroxychloroquine, sulfasalazine, and demeclocycline. On November 13, 1999, leflunomide therapy was started, at which time his weight was 185 pounds. Two months later, he noted improvement, and his weight was 178 pounds. Four months after starting leflunomide therapy, his weight dropped to 168 pounds. He continued to take prednisone at ≤5 mg/day during this entire period of observation, and never experienced diarrhea.
An extensive medical evaluation was undertaken, which included panendoscopy, a chest radiograph, and blood studies. No etiology for his weight loss was ascertained. Leflunomide was stopped when his weight dropped to 154 pounds, a loss of 31 pounds. Etanercept was begun, and his weight has remained stable at 154 pounds.
Patient 2 is a 59‐year‐old woman with an 8‐year history of seropositive RA. DMARD treatment prior to initiation of leflunomide therapy included hydroxychloroquine, sulfasalazine, and methotrexate. She was not treated with corticosteroids. Her medical history was significant for ulcerative colitis, with normal results on repeated colonoscopies in the preceding 5 years. Her weight prior to initiation of leflunomide was 137 pounds. On December 3, 1998, leflunomide therapy was introduced in addition to her background medications, including levothyroxine 0.1 mg daily, celecoxib, and sulfasalazine. Three months after starting therapy, her weight decreased to 118 pounds, a loss of 19 pounds. She had no gastrointestinal complaints, including diarrhea. An extensive evaluation of her weight loss, including chest radiographs, was unremarkable. Due to the excellent response to leflunomide therapy, she elected to continue taking the drug. Her weight has stabilized at 117 pounds.
Patient 3 is a 60‐year‐old woman who has had seropositive RA for >20 years. Prior DMARD therapy included hydroxychloroquine, gold salt therapy, methotrexate, sulfasalazine, and azathioprine. On December 2, 1998, leflunomide therapy was initiated. Her weight was 135 pounds. Over the next year, her weight progressively fell to 116 pounds, a decrease of 19 pounds. She had no diarrhea, nausea, or vomiting. Extensive evaluations included panendoscopy, abdominal and pelvic computed tomography scans, and chest radiographs, with no abnormalities discovered. Her prednisone dosage remained unchanged at ≤10 mg/day during this period of observation. She has continued to take leflunomide because of the beneficial effect of this therapy.
Patient 4 is a 54‐year‐old woman with 6 years of seropositive RA, who previously was treated unsuccessfully with gold salts, hydroxychloroquine, sulfasalazine, azathioprine, and methotrexate. Her current medications included prednisone, ranging from 5 mg to 12.5 mg/day, and naproxen. Nine months prior to leflunomide therapy, the patient underwent an anterior sigmoid colon resection for diverticulitis, with an end sigmoid colostomy performed. Due to persistent synovitis, leflunomide was started in May 1999. One month after the initiation of leflunomide therapy, her weight was 161 pounds. Over the next 6 months, her weight dropped steadily to 124 pounds, a loss of 37 pounds. She described an increased loss of appetite, but there was no change in her stools. Evaluations included chest computed tomography, laboratory studies, stool guaic tests, and an upper gastrointestinal examination followed by assessment of the small bowel. The patient elected to continue taking leflunomide despite the weight loss, because of her good clinical response.
Patient 5 is a 58‐year‐old woman who has had RA for ∼20 years. Prior DMARD therapy included hydroxychloroquine, gold salts, azathioprine, and cyclosporin A. Despite ongoing therapy with methotrexate at 17.5 mg per week and 4 mg per day of prednisone, she continued to have polyarthritis. When leflunomide was started, her weight was 202 pounds. Over the next 3 months, she noticed less pain and swelling in her joints. The prednisone was tapered and later discontinued entirely. She noted a reduction of weight to 149 pounds, a 53‐pound weight loss. She denied having any gastrointestinal symptoms, including anorexia and diarrhea. Results of laboratory studies, including a complete blood cell count as well as assessment of liver, renal, and thyroid function, were all within normal limits. She has continued taking methotrexate and leflunomide without further weight loss.
Lupus is mainly treated with medicine. The types of drugs that have been used to treat lupus include NSAIDs, corticosteroids and other immune system suppressing drugs, hydroxychloroquine, and the newest lupus drug, Benlysta.
Lupus medications work in different ways. What they have in common is that they all reduce swelling in the body, Fitzgerald says. Which drugs you need — either alone or in combination — depends on your particular case.
- NSAIDs. These common drugs — like aspirin, ibuprofen, naprosyn, or indomethacin, help reduce swelling, stiffness, and pain. For some people with very mild lupus, NSAIDs alone are enough to control symptoms.
- Antimalarial drugs. Hydroxychloroquine (Plaquenil) is used to treat malaria, and researchers have found that this drug also helps with lupus flares. These drugs work well with mild to moderate cases of lupus. They can help ease lupus symptoms such as joint swelling and skin rashes. But hydroxychloroquine is not used alone for severe cases of lupus in which the kidneys or other organs are involved.
“Antimalarials have almost become like a daily multivitamin” for people with mild to moderate lupus,” Fitzgerald says. The drugs’ side effects are generally mild, and these medicines may help prevent complications, improving a person’s long-term diagnosis.
- Benlysta. Benlysta was approved in 2011 to treat lupus in combination with other lupus drugs. Although it does not benefit all patients with lupus, it helps some reduce doses of steroids, which can have troubling side effects. Benlysta, also called belimumab, is an antibody that recognizes and blocks a protein in the immune system that contributes to the immune system’s attack on the body’s own cells. The most common side effects are nausea, diarrhea, and fever.
- Corticosteroids. Oral steroids – such as prednisone and prednisolone — can be a lifesaving treatment for people with lupus. During serious lupus flares that affect organs such as the kidneys, high doses of steroids can quickly control symptoms.
However, steroids can also have troublesome or severe side effects, including weight gain, mood changes, and depression. In the long-term, these medicines can increase the risk of osteoporosis and other bone complications, infections, and weight-related conditions such as diabetes or high blood pressure.
“The goal with steroids is to get the person onto the lowest possible dose necessary to control symptoms,” says Fitzgerald. As you get better, your rheumatologist will probably reduce the dose. Some people need long-term treatment with low-dose steroids; others can stop taking them altogether.
Steroids also come as a topical treatment, which can help treat skin rashes caused by lupus.
- Immunosuppressive drugs. Because lupus is a disease caused by an overactive immune system, drugs that suppress the immune system can help relieve symptoms. These powerful drugs include azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, and others. They are generally used in people who have severe lupus, when corticosteroids haven’t worked or aren’t an option.
Immunosuppressives can cause serious side effects, because they block the body’s ability to fight infection. If you take immunosuppressive drugs, you need to get medical attention at the first sign of an infection or illness.
- New and experimental medications. A number of lupus medications — many designed to target specific immune cells — are being tested in studies. If you’re interested, talk to your doctor about joining a clinical trial.
- Other medications. Because lupus can affect so many different parts of the body, many people need other medications depending on their symptoms. These can include statins, diuretics, anticoagulants, drugs to strengthen bones, blood pressure medicines, antibiotics, stimulants, and others.
Keep in mind that it might take your rheumatologist some time to find the right lupus drug or combination. You may also need different medicines over time as your symptoms change.
“There is no one medication that helps all people with lupus,” says Fitzgerald. “A drug might work well in some people and not at all in others. Unfortunately we don’t have a way to predict who will benefit and who won’t.”
The following adverse reactions have been identified during post-approval use of PLAQUENIL or other 4-aminoqunoline compounds. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders : Bone marrow failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia. Hemolysis reported in individuals with glucose-6- phosphate dehydrogenase (G-6-PD) deficiency.
Cardiac disorders : Cardiomyopathy which may result in cardiac failure and in some cases a fatal outcome (see WARNINGS and OVERDOSAGE). PLAQUENIL prolongs the QT interval. Ventricular arrhythmias and torsade de pointes have been reported in patients taking PLAQUENIL (see OVERDOSAGE and DRUG INTERACTIONS).
Ear and labyrinth disorders : Vertigo, tinnitus, nystagmus, nerve deafness, deafness.
Eye disorders : Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance), visual field defects (paracentral scotomas) and visual disturbances (visual acuity), maculopathies (macular degeneration), decreased dark adaptation, color vision abnormalities, corneal changes (edema and opacities) including corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision).
Gastrointestinal disorders : Nausea, vomiting, diarrhea, and abdominal pain.
General disorders and administration site conditions : Fatigue.
Hepatobiliary disorders : Liver function tests abnormal, hepatic failure acute.
Immune system disorders : Urticaria, angioedema, bronchospasm
Metabolism and nutrition disorders : Decreased appetite, hypoglycemia, porphyria, weight decreased.
Musculoskeletal and connective tissue disorders : Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction.
Nervous system disorders : Headache, dizziness, seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, and tremor have been reported with this class of drugs.
Psychiatric disorders : Affect/emotional lability, nervousness, irritability, nightmares, psychosis, suicidal behavior.
Skin and subcutaneous tissue disorders : Rash, pruritus, pigmentation disorders in skin and mucous membranes, hair color changes, alopecia. Dermatitis bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity, dermatitis exfoliative, acute generalized exanthematous pustulosis (AGEP). AGEP has to be distinguished from psoriasis, although PLAQUENIL may precipitate attacks of psoriasis. It may be associated with pyrexia and hyperleukocytosis.
Read the entire FDA prescribing information for Plaquenil (Hydroxychloroquine)