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PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLETS: ADVERSE REACTIONS / SIDE EFFECTS

The following adverse reactions have been identified during post-approval use of Plaquenil (Hydroxychloroquine Sulfate) tablets 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: anemia, bone marrow failure, aplastic anemia, leukopenia, agranulocytosis, 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. Plaquenil prolongs the QT interval. Ventricular arrhythmias and torsade de pointes have been reported in patients taking Hydroxychloroquine (Plaquenil).

Ear and labyrinth disorders: tinnitus, vertigo, nystagmus, deafness, nerve 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), color vision abnormalities, decreased dark adaptation, corneal changes (edema and opacities) including corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision).

Gastrointestinal disorders: vomiting, nausea, diarrhea, abdominal pain.

General disorders and administration site conditions: fatigue.

Hepatobiliary disorders: hepatic failure acute, liver function tests abnormal.

Immune system disorders: angioedema, urticaria, bronchospasm.

Metabolism and nutrition disorders: hypoglycemia, decreased appetite, 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: dizziness, headache, seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, and tremor have been reported with this class of drugs.

Psychiatric disorders: affect/emotional lability, irritability, nervousness, nightmares, suicidal behavior, psychosis.

Skin and subcutaneous tissue disorders: pruritus, rash, 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), dermatitis exfoliative, photosensitivity, acute generalized exanthematous pustulosis (AGEP). AGEP has to be distinguished from psoriasis, although Hydroxychloroquine (Plaquenil) tablets may precipitate attacks of psoriasis. It may be associated with pyrexia and hyperleukocytosis.

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