Hydroxychloroquineside effects

The following adverse reactions are described in greater detail in other sections: Cardiomyopathy and Ventricular Arrhythmias Retinal Toxicity Serious Skin Reactions Worsening of Psoriasis Risks Associated with Use in Porphyria Hematologic Toxicity Hemolytic Anemia Associated with G6PD Skeletal Muscle Myopathy or Neuropathy Neuropsychiatric Reactions Including Suicidality Hypoglycemia Renal Toxicity The following adverse reactions have been identified during post-approval use of 4-­aminoquinoline drugs, including hydroxychloroquine sulfate tablets. 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 depression, anemia, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia Cardiac disorders: Cardiomyopathy, cardiac failure, QT-interval prolongation, ventricular tachycardia, torsades de pointes, atrioventricular block, bundle branch block, sick sinus syndrome, pulmonary hypertension Ear and labyrinth disorders: Vertigo, tinnitus, nystagmus, sensorineural hearing loss Eye disorders: Retinopathy, retinal pigmentation changes (typically bull’s eye appearance), visual field defects (paracentral scotomas), macular degeneration, corneal edema, corneal opacities, decreased dark adaptation Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain General disorders: Fatigue Hepatobiliary disorders: Abnormal liver function tests, fulminant hepatic failure Immune system disorders: Urticaria, angioedema, bronchospasm Metabolism and nutrition disorders: Anorexia, hypoglycemia, weight loss Musculoskeletal and connective tissue disorders: Proximal myopathy, depressed tendon reflexes, abnormal nerve conduction Nervous system disorders: Ataxia, dizziness, headache, seizure, extrapyramidal disorders (dystonia, dyskinesia, tremor) Neuropsychiatric disorders: Affect/emotional lability, irritability, nervousness, psychosis, suicidal ideation, suicidal behavior, depression, hallucinations, anxiety, agitation, confusion, delusions, paranoia, mania and sleep disorders (insomnia, night terrors, nightmares) Skin and subcutaneous tissue disorders: Alopecia, hair color changes, rash, pruritus, photosensitivity, psoriasis exacerbation, hyperpigmentation, exfoliative dermatitis, erythema multiforme, acute generalized exanthematous pustulosis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) The most common adverse reactions reported are: nausea, vomiting, diarrhea, and abdominal pain. To report SUSPECTED ADVERSE REACTIONS, contact Appco Pharma LLC at 1-855-672-7726 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.