Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Skin Rash and Hypersensitivity [see Warnings and Precautions ( 5.1 )] Nephrotoxicity [see Warnings and Precautions ( 5.3 )] Hepatoxicity [see Warnings and Precautions ( 5.4 )] Myelosuppression [see Warnings and Precautions ( 5.5 )] Potential Effect on Driving and Use of Machinery [see Warnings and Precautions ( 5.6 )] The following adverse reactions associated with the use of allopurinol tablets were identified in literature, unpublished clinical trials or postmarketing reports.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 tablets 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.
5 WARNINGS AND PRECAUTIONS Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions.
Discontinue allopurinol tablets at the first appearance of skin rash or other signs of hypersensitivity reaction.
( 5.1 ) Gout Flares: May occur during initiation of treatment.
Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended.
( 5.2 ) Nephrotoxicity: Allopurinol may affect kidney function.
Like all medications, Allopurinol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: