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Plaquenil Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Plaquenil (hydroxychloroquine) is 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. It is an antimalarial medication. This medication is available in generic form. Common side effects include nausea, stomach cramps, loss of appetite, diarrhea, dizziness, or headache.
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.
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 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 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.
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
Following the administration in doses adequate for the treatment of an acute malarial attack, mild and transient headache, dizziness, and gastrointestinal complaints (diarrhea, anorexia, nausea, abdominal cramps and, on rare occasions, vomiting) may occur. Cardiomyopathy has been rarely reported with high daily dosages of hydroxychloroquine.
LUPUS ERYTHEMATOSUS AND RHEUMATOID ARTHRITIS
Not all of the following reactions have been observed with every 4-aminoquinoline compound during long-term therapy, but they have been reported with one or more and should be borne in mind when drugs of this class are administered. Adverse effects with different compounds vary in type and frequency.
Neuromuscular Reactions: Skeletal muscle palsies or skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups which may be associated with mild sensory changes, depression of tendon reflexes and abnormal nerve conduction.
A. Ciliary body: Disturbance of accommodation with symptoms of blurred vision. This reaction is dose-related and reversible with cessation of therapy.
B. Cornea: Transient edema, punctate to lineal opacities, decreased corneal sensitivity. The corneal changes, with or without accompanying symptoms (blurred vision, halos around lights, photophobia), are fairly common, but reversible. Corneal deposits may appear as early as three weeks following initiation of therapy.
The incidence of corneal changes and visual side effects appears to be considerably lower with hydroxychloroquine than with chloroquine.
C. Retina: Macula: Edema, atrophy, abnormal pigmentation (mild pigment stippling to a "bull's-eye" appearance), loss of foveal reflex, increased macular recovery time following exposure to a bright light (photo-stress test), elevated retinal threshold to red light in macular, paramacular, and peripheral retinal areas.
Other fundus changes include optic disc pallor and atrophy, attenuation of retinal arterioles, fine granular pigmentary disturbances in the peripheral retina and prominent choroidal patterns in advanced stage.
D. Visual field defects: Pericentral or paracentral scotoma, central scotoma with decreased visual acuity, rarely field constriction, abnormal color vision.
The most common visual symptoms attributed to the retinopathy are: reading and seeing difficulties (words, letters, or parts of objects missing), photophobia, blurred distance vision, missing or blacked out areas in the central or peripheral visual field, light flashes and streaks.
Retinopathy appears to be dose related and has occurred within several months (rarely) to several years of daily therapy; a small number of cases have been reported several years after antimalarial drug therapy was discontinued. It has not been noted during prolonged use of weekly doses of the 4-aminoquinoline compounds for suppression of malaria.
Patients with retinal changes may have visual symptoms or may be asymptomatic (with or without visual field changes). Rarely scotomatous vision or field defects may occur without obvious retinal change.
Retinopathy may progress even after the drug is discontinued. In a number of patients, early retinopathy (macular pigmentation sometimes with central field defects) diminished or regressed completely after therapy was discontinued. Paracentral scotoma to red targets (sometimes called "premaculopathy") is indicative of early retinal dysfunction which is usually reversible with cessation of therapy.
A small number of cases of retinal changes have been reported as occurring in patients who received only hydroxychloroquine. These usually consisted of alteration in retinal pigmentation which was detected on periodic ophthalmologic examination; visual field defects were also present in some instances. A case of delayed retinopathy has been reported with loss of vision starting one year after administration of hydroxychloroquine had been discontinued.
Dermatologic Reactions: Bleaching of hair, alopecia, pruritus, skin and mucosal pigmentation, photosentivity, and skin eruptions (urticarial, morbilliform, lichenoid, maculopapular, purpuric, erythema annulare centrifugum, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, and exfoliative dermatitis).
Hematologic Reactions: Various blood dyscrasias such as aplastic anemia, agranulocytosis, leukopenia, anemia, thrombocytopenia (hemolysis in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency).
Gastrointestinal Reactions: Anorexia, nausea, vomiting, diarrhea, and abdominal cramps. Isolated cases of abnormal liver function and fulminant hepatic failure.
Cardiomyopathy has been rarely reported with high daily dosages of hydroxychloroquine.
No information provided.
Read the entire FDA prescribing information for Plaquenil (Hydroxychloroquine)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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