Plaquenil Side Effects

Generic name: hydroxychloroquine

Note: This document contains side effect information about hydroxychloroquine. Some of the dosage forms listed on this page may not apply to the brand name Plaquenil.

Some side effects of Plaquenil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to hydroxychloroquine: oral tablet

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 (the active ingredient contained in 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.

Get emergency medical help if you have any of these signs of an allergic reaction while taking hydroxychloroquine: 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 of hydroxychloroquine 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.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to hydroxychloroquine: compounding powder, oral tablet

General

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

Ocular

Ocular side effects have included disturbances of accommodation with symptoms of blurred vision (dose-related and reversible with treatment cessation). Corneal side effects have included transient edema, punctate to lineal opacities, decreased corneal sensitivity, corneal changes (with or without accompanying symptoms, including blurred vision, halos around lights, photophobia), and corneal deposits. Retinal (macular) 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), and 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, rarely field constriction, and abnormal color vision. The most common visual symptoms attributed to retinopathy are reading and vision difficulties (words, letters, or parts of objects missing), photophobia, blurred distance vision, missing or blacked out areas in the central or peripheral visual field, and light flashes and streaks. 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. A few cases of retinal changes consisting of change in retinal pigmentation (detected on periodic ophthalmologic examination) with visual field defects in some instances have been reported in patients receiving only hydroxychloroquine (the active ingredient contained in Plaquenil) A case of delayed retinopathy with vision loss starting 1 year after hydroxychloroquine discontinuation has been reported. Night vision difficulties and immediate blurred vision have been reversible with treatment cessation.

The corneal changes (fairly common) have been reversible. Corneal deposits have been reported as early as 3 weeks after the initiation of therapy.

Retinopathy appears to be dose related and has occurred within several months (rarely) to several years of daily therapy.

Gastrointestinal

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

Nervous system

Nervous system side effects have included headache, dizziness, vertigo, tinnitus, nystagmus, nerve deafness, convulsions, and ataxia.

Psychiatric

Psychiatric side effects have included irritability, nervousness, emotional changes, nightmares, and psychosis.

Musculoskeletal

Musculoskeletal side effects have included skeletal muscle palsies, 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. Absent or hypoactive deep tendon reflexes and extraocular muscle palsies have been reported. Neuromyotoxicity has been associated with hydroxychloroquine (the active ingredient contained in Plaquenil) concurrently with worsening renal function.

Dermatologic

Mucocutaneous hyperpigmentation over all extremities, the torso, and the hairline has been reported in an elderly man after long-term hydroxychloroquine (the active ingredient contained in Plaquenil) 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, photosensitivity, and skin eruptions (urticarial, morbilliform, lichenoid, maculopapular, purpuric, erythema annulare centrifugum, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, 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, anemia, and thrombocytopenia. Hemolysis has been reported in individuals with glucose-6-phosphate dehydrogenase deficiency.

Cardiovascular

The causal relationship of hydroxychloroquine (the active ingredient contained in Plaquenil) to cardiomyopathy has not been established.

Cardiovascular side effects have rarely included cardiomyopathy with high daily dosages.

Hepatic

Hepatic side effects have included isolated cases of abnormal liver function and fulminant hepatic failure.

Metabolic

Metabolic side effects have included weight loss and exacerbation or precipitation of porphyria.

Other

Other side effects have included lassitude.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions (urticaria, angioedema, and bronchospasm) and hypersensitivity myocarditis.

Endocrine

Endocrine side effects have included a case report of hypoglycemia induced by hydroxychloroquine (the active ingredient contained in Plaquenil) in a type II diabetic treated for polyarthritis.