The following adverse reactions have been identified during
post-approval use of PLAQUENIL 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 : Bone marrow
failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and
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 (see WARNINGS
and OVERDOSAGE). PLAQUENIL prolongs the QT interval. Ventricular arrhythmias
and torsade de pointes have been reported in patients taking PLAQUENIL (see OVERDOSAGE
and DRUG INTERACTIONS).
Ear and labyrinth disorders : Vertigo, tinnitus,
nystagmus, nerve deafness, 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), decreased dark adaptation, color vision abnormalities, corneal
changes (edema and opacities) including corneal deposition of drug with or
without accompanying symptoms (halo around lights, photophobia, blurred
Gastrointestinal disorders : Nausea, vomiting,
diarrhea, and abdominal pain.
General disorders and administration site conditions :
Hepatobiliary disorders : Liver function tests
abnormal, hepatic failure acute.
Immune system disorders : Urticaria, angioedema,
Metabolism and nutrition disorders : Decreased
appetite, hypoglycemia, 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 : Headache, dizziness,
seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, and
tremor have been reported with this class of drugs.
Psychiatric disorders : Affect/emotional lability,
nervousness, irritability, nightmares, psychosis, suicidal behavior.
Skin and subcutaneous tissue disorders : Rash,
pruritus, 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), photosensitivity, dermatitis exfoliative, acute
generalized exanthematous pustulosis (AGEP). AGEP has to be distinguished from
psoriasis, although PLAQUENIL may precipitate attacks of psoriasis. It may be
associated with pyrexia and hyperleukocytosis.
To report SUSPECTED ADVERSE REACTIONS, contact
Concordia Pharmaceuticals Inc. at 1- 877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.