Allopurinolside effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Skin Rash and Hypersensitivity Nephrotoxicity Hepatoxicity Myelosuppression Potential Effect on Driving and Use of Machinery The following adverse reactions associated with the use of allopurinol were identified in literature, unpublished clinical trials or postmarketing reports. Because some of these reactions were 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. The most frequent adverse reaction to allopurinol is skin rash. Most Common Adverse Reactions (≥ 1%) Gastrointestinal: Diarrhea, nausea, alkaline phosphatase increase, AST/ALT increase.

Metabolic and Nutritional: Acute attacks of gout.

Skin and Appendages: Rash, maculopapular rash. Less Common Adverse Reactions (< 1%) Body As a Whole: Ecchymosis, fever, headache, malaise.

Cardiovascular: Necrotizing angiitis, vasculitis, pericarditis, peripheral vascular disease, thrombophlebitis, bradycardia, vasodilation.

Gastrointestinal: Hepatic necrosis, granulomatous hepatitis, hepatomegaly, hyperbilirubinemia, cholestatic jaundice, vomiting, intermittent abdominal pain, gastritis, dyspepsia, hemorrhagic pancreatitis, gastrointestinal bleeding, stomatitis, salivary gland swelling, hyperlipidemia, tongue edema, anorexia.

Hemic and Lymphatic: Thrombocytopenia, eosinophilia, leukocytosis, leukopenia, aplastic anemia, agranulocytosis, eosinophilic fibrohistiocytic lesion of bone marrow, pancytopenia, prothrombin decrease, anemia, hemolytic anemia, reticulocytosis, lymphadenopathy, lymphocytosis.

Musculoskeletal: Myopathy, arthralgias, myalgia.

Nervous: Peripheral neuropathy, neuritis, paresthesia, somnolence, optic neuritis, confusion, dizziness, vertigo, foot drop, decrease in libido, depression, amnesia, tinnitus, asthenia, insomnia.

Respiratory: Epistaxis, bronchospasm, asthma, pharyngitis, rhinitis.

Skin and Appendages: Erythema multiforme exudativum (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), hypersensitivity vasculitis, purpura, vesicular bullous dermatitis, exfoliative dermatitis, eczematoid dermatitis, pruritus, urticaria, alopecia, onycholysis, lichen planus, furunculosis, facial edema, sweating, skin edema.

Special Senses: Taste loss/perversion, cataracts, macular retinitis, iritis, conjunctivitis, amblyopia.

Urogenital: Renal failure, uremia, nephritis, impotence, primary hematuria, albuminuria.

Endocrine: Infertility (male), hypercalcemia, gynecomastia (male). Most common adverse reactions (incidence > 1%) are nausea, diarrhea, and increase in liver function tests. To report SUSPECTED ADVERSE REACTIONS, Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.