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Hquine

Hquine Side Effects

hydroxychloroquine

Manufacturer:

Incepta Pharmaceuticals

Distributor:

Atlanta Medicare
Full Prescribing Info
Side Effects
The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1 and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01%; Not known (frequency cannot be estimated from available data).
Eye disorders: Common: Blurring of vision due to a disturbance of accommodation which is dose dependent and reversible may also occur.
Uncommon: Retinopathy with changes in pigmentation and visual field defects but appears to be uncommon if the recommended daily dose is not exceeded. In its early form it appears reversible on discontinuation of hydroxychloroquine. If allowed to develop, there may be a risk of progression even after treatment withdrawal.
Patients with retinal changes may be asymptomatic initially, or may have scotomatous vision with paracentral, pericentral ring types, temporal scotomas and abnormal color vision.
Corneal changes including edema and opacities have been reported. They are either symptomless or may cause disturbances such as haloes, blurring of vision or photophobia. They may be transient or are reversible on stopping treatment.
Not known: Case of maculopathies and macular degeneration have been reported and may be irreversible.
Skin and subcutaneous tissue disorders: Common: skin rash, pruritus.
Uncommon: Pigmentation disorders in skin and mucous membranes, bleaching of hair, alopecia. These usually resolve readily on stopping treatment.
Not known: Bullous eruptions including erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), photosensitivity, exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP) has to be distinguished from psoriasis, although hydroxychloroquine may precipitate attacks of psoriasis. It may be associated with fever and hyperleukocytosis. Outcome is usually favourable after drug withdrawal.
Gastrointestinal disorders: Very common: Abdominal pain, nausea.
Common: Diarrhoea, vomiting.
These symptoms usually resolve immediately on reducing the dose or on stopping treatment.
Psychiatric disorders: Common: Affect lability.
Uncommon: Nervousness.
Not known: Psychosis, suicidal behaviour.
Nervous system disorders: Common: Headache.
Uncommon: Dizziness.
Not known: Convulsions, Extrapyramidal disorders such as dystonia, dyskinesia, tremor.
Ear and labyrinth disorders: Uncommon: Vertigo, tinnitus.
Not known: Hearing loss.
Musculoskeletal and connective tissue disorders: Uncommon: Sensorimotor disorders.
Not known: Skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups. Myopathy may be reversible after drug discontinuation, but recovery may take many months. Depression of tendon reflexes and abnormal nerve conduction studies.
Cardiac disorders: Not known: QT interval prolongation in patients with specific risk factors, which may lead to arrhythmia (torsade de pointes, ventricular tachycardia).
Cardiopathy which may result in cardiac failure and in some cases a fatal outcome.
Chronic toxicity should be considered when conduction disorders (bundle branch block/atrioventricular heart block) as well as biventricular hypertrophy are found. Drug withdrawal may lead to recovery.
Blood and lymphatic system disorder: Not Known: Bone-marrow depression, anemia, aplastic anemia, agranulocytosis, leucopenia and thrombocytopenia.
Metabolism and nutrition disorders: Common: Anorexia.
Not known: Hypoglycemia.
Hydroxychloroquine may precipitate or exacerbate porphyria.
Immune system disorders: Not known: Urticaria, angioedema and bronchospasm.
Hepatobiliary disorders: Uncommon: Abnormal liver function tests.
Not known: Fulminant hepatic failure.
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