"March 9, 2011 -- The FDA has approved Benlysta, the first new lupus treatment in 50 years.
An FDA advisory panel last November voted 13-2 in favor of approval. But the panel noted that Benlysta is no wonder drug. Overall, it offered a"...
Plaquenil Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Plaquenil (hydroxychloroquine) is an antimalarial medication used to treat or prevent malaria, a disease caused by parasites, which enter the body through the bite of a mosquito. It is also used to treat symptoms of rheumatoid arthritis and discoid or systemic lupus erythematosus. Plaquenil is available in generic form. Common side effects of Plaquenil include nausea, vomiting, stomach pain or cramps, loss of appetite, weight loss, diarrhea, dizziness, spinning sensation, headache, ringing in your ears, mood changes, nervousness, irritability, skin rash, itching, or hair loss.
The adult dose of Plaquenil to suppress malaria is 400 mg on the same day each week. The pediatric weekly suppressive dosage is 5 mg/kg of body weight. The adult dose of Plaquenil to treat an acute attack of malaria is an initial dose of 800 mg followed by 400 mg in six to eight hours and 400 mg for two more days. To treat lupus erythematosus, the average adult dose is 400 mg once or twice daily. Plaquenil may interact with acetaminophen, cancer medications, tuberculosis medications, birth control pills or hormone replacement therapy, arthritis medications, ACE inhibitors, antibiotics, antifungals, cholesterol medications, HIV/AIDS medications, NSAIDs (non-steroidal anti-inflammatory drugs), or seizure medications. Tell your doctor all medications you use. Plaquenil should be used only when prescribed during pregnancy. This medication is not recommended to treat rheumatoid arthritis during pregnancy. This medication passes into breast milk. Consult your doctor before breast-feeding.
Our Plaquenil (hydroxychloroquine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Plaquenil in Detail - Patient Information: Side Effects
Some people taking this medication over long periods of time or at high doses have developed irreversible damage to the retina of the eye. Stop taking hydroxychloroquine 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.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- muscle weakness, twitching, or uncontrolled movement;
- loss of balance or coordination;
- blurred vision, light sensitivity, seeing halos around lights;
- pale skin, easy bruising or bleeding;
- confusion, unusual thoughts or behavior; or
- seizure (convulsions).
Less serious side effects may include:
- headache, ringing in your ears, spinning sensation;
- nausea, vomiting, stomach pain;
- loss of appetite, weight loss;
- mood changes, feeling nervous or irritable;
- skin rash or itching; or
- hair loss.
Read the entire detailed patient monograph for Plaquenil (Hydroxychloroquine)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Plaquenil Overview - Patient Information: Side Effects
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.
Tell your doctor immediately if any of these unlikely but serious side effects occur: arm/leg/back pain, fast/irregular heartbeat, hair loss/color change, mental/mood changes (e.g., anxiety, depression, hallucinations), ringing in the ears/hearing loss, worsening of skin conditions (e.g., psoriasis).
This medication may infrequently cause serious (sometimes permanent) eye problems or muscle damage, especially if you take it for a long time. Seek immediate medical attention if any of these unlikely but very serious side effects occur: sensitivity to light, vision changes (e.g., blurred vision, seeing light flashes/streaks/halos, missing/blacked-out areas of vision), muscle weakness.
Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, severe nausea/vomiting, easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), seizures, shortness of breath, swelling ankles/feet, extreme tiredness, dark urine, yellowing eyes/skin.
This medication may infrequently cause low blood sugar (hypoglycemia). Tell your doctor right away if you develop symptoms of low blood sugar, such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. If you have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication.
A very serious allergic reaction is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), 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.
Read the entire patient information overview for Plaquenil (Hydroxychloroquine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Plaquenil FDA Prescribing Information: Side Effects
The following Council for International Organizations of Medical Sciences (CIOMS) frequency rating is used, when applicable: Very common ≥ 10 %; Common ≥ 1 and < 10 %; Uncommon ≥ 0.1 and < 1 %; Rare ≥ 0.01 and < 0.1 %; Very rare < 0.01 %; Not known (frequency cannot be estimated from available data).
Blood and Lymphatic System Disorders
Not known: Cardiomyopathy, which may result in cardiac failure and in some cases a fatal outcome.
Chronic toxicity should be considered when conduction disorders (bundle branch block/ atrioventricular heart block) as well as biventricular hypertrophy are found. Drug discontinuation may lead to recovery (see WARNINGS AND PRECAUTIONS, Symptoms And Treatment Of Overdosage).
Ear and Labyrinth Disorders
Not known: Hearing loss including cases of irreversible hearing loss.
Common: Blurring of vision due to a disturbance of accommodation which is dose dependent and reversible (see WARNINGS AND PRECAUTIONS).
Uncommon: Maculopathies which may be irreversible.
Retinopathy with changes in pigmentation and visual field defects. In its early form it appears reversible upon discontinuation of the drug. If allowed to develop however, there may be a risk of progression even after treatment withdrawal.
Patients with retinal changes may be asymptomatic initially, or may have scotomatous vision with paracentral, pericentral ring types, temporal scotomas, abnormal colour visions, reduction in visual acuity, night blindness, difficulty reading and skipping words.
Corneal changes including edema and opacities. They are either symptomless or may cause disturbances such as halos around lights especially at night, blurring of vision or photophobia. They may be transient or are reversible upon discontinuation of therapy (see WARNINGS AND PRECAUTIONS).
Not known: Macular degeneration which may be irreversible.
Very common: Abdominal pain, nausea
Common: Diarrhea, vomiting
These symptoms usually resolve immediately upon reducing the dose or upon stopping the treatment.
Uncommon: Abnormal liver function tests
Not known: Fulminant hepatic failure (see WARNINGS AND PRECAUTIONS)
Immune System Disorders
Metabolism and Nutrition Disorders
Common: Anorexia (usually resolves immediately upon reducing the dose or upon stopping the treatment).
Musculoskeletal and Connective Tissue Disorders
Uncommon: Sensory motor disorders
Not known: Skeletal muscle palsies or skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups. Depression of tendon reflexes, abnormal results of nerve conduction tests. Myopathy may be reversible after drug discontinuation, but recovery may take many months (see WARNINGS AND PRECAUTIONS).
Nervous System Disorders
Common: Affect lability
Not known: Psychosis, suicidal behavior.
Skin and Subcutaneous Tissue Disorders
Common: Skin rash, pruritus
Uncommon: Pigmentary changes in skin and mucous membranes, bleaching of hair, alopecia. These usually resolve readily upon cessation of therapy.
Not known: Bullous eruptions (including urticarial, morbilliform, lichenoid, maculopapular, purpuric, erythema annulare centrifugum), toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), photosensitivity, exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP).
AGEP has to be distinguished from psoriasis, although PLAQUENIL may precipitate attacks of psoriasis. It may be associated with fever and hyperleukocytosis. Outcome is usually favorable after discontinuation of drug.
Read the entire FDA prescribing information for Plaquenil (Hydroxychloroquine)
Additional Plaquenil Information
Plaquenil - User Reviews
Plaquenil User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
Get breaking medical news.