Plaquenil Side Effects

Please note - some side effects for Plaquenil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Plaquenil - for the Consumer

Plaquenil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Plaquenil:

Diarrhea; dizziness; loss of appetite; mild headache; nausea; stomach cramps.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; decreased coordination; fever, chills, or sore throat; hearing loss; mental or mood changes; muscle weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; trouble walking; unusual bruising or bleeding; yellowing of the skin or eyes.

Side Effects by Body System

General

In general, although not every side effect listed in the side effects section may have been reported with the use of hydroxychloroquine, they have all been reported with the use of one or more 4-aminoquinoline compounds.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, anorexia, nausea, abdominal cramps, and vomiting. A case of pigmentation of the gums has also been reported.

Nervous system

Nervous system side effects have included irritability, nervousness, emotional changes, nightmares, headache, dizziness, vertigo, tinnitus, nystagmus, deafness, convulsions, and ataxia.

Musculoskeletal

Musculoskeletal side effects have included skeletal muscle weakness, absent or hypoactive deep tendon reflexes, and extraocular muscle palsies. Neuromyotoxicity has been associated with hydroxychloroquine concurrently with worsening renal function.

Ocular

Ocular side effects have included disturbances of accommodation with symptoms of blurred vision. Side effects to the cornea have included transient edema, punctate to lineal opacities, and decreased corneal sensitivity. These corneal changes, with or without accompanying symptoms (blurred vision, halos around lights, photophobia) have been frequently reported. The most common visual symptoms attributed to retinopathy are reading and vision difficulties, photophobia, blurred vision, missing or blacked out areas in the central or peripheral visual field, light flashes, and streaks. Other retinal side effects have included edema, atrophy, abnormal pigmentation (mild pigment stippling to a "bullseye" appearance), loss of foveal reflex, increased macular recovery time following exposure to a bright light (photostress test), elevated retinal threshold to red light in macular, paramacular, and peripheral retinal areas. Other fundus changes have included optic disc pallor and atrophy, attenuation of retinal arterioles, fine granular pigmentary disturbances in the peripheral retina, and prominent choroidal patterns in advanced stage. Visual field defects have included pericentral or paracentral scotoma, central scotoma with decreased visual acuity and rarely field constriction.

Blurred vision is dose related and usually reversible with cessation of therapy.

Corneal changes have been reported as early as three weeks after the initiation of therapy and are also usually reversible.

Retinopathy appears to be dose related, generally occurring after several years of daily therapy.

Dermatologic

Mucocutaneous hyperpigmentation over all extremities, the torso, and the hairline has been reported in an elderly man after long-term hydroxychloroquine use. Skin biopsies demonstrated sharply defined red-brown fibers in the deep dermis and the classic "banana-shaped body" associated with exogenous ochronosis.

Dermatologic side effects have included nonlight-sensitive psoriasis, bleaching of hair, alopecia, pruritus, skin and mucosal pigmentation, skin eruptions (urticarial, morbilliform, lichenoid, maculopapular, purpuric, erythema annulare centrifugum, and exfoliative dermatitis). A case of generalized pustular drug rash has also been reported.

Hematologic

Hematologic side effects have included various blood dyscrasias, such as aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia (hemolysis in individuals with glucose-6-phosphate dehydrogenase [G-6-PD] deficiency).

Cardiovascular

The causal relationship of hydroxychloroquine to cardiomyopathy has not been established.

Cardiovascular side effects have rarely included cardiomyopathy.

Endocrine

Endocrine side effects have included a case report of hypoglycemia induced by hydroxychloroquine in a type II diabetic treated for polyarthritis.

Hepatic

Hepatic side effects have included a case report of fulminant hepatic failure.

Psychiatric

Psychiatric side effects have included psychosis.

Other

Other side effects have included weight loss, lassitude, and exacerbation or precipitation of porphyria.

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity myocarditis.

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