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 Prophylaxis of Gout Flares: The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea.
Treatment of Gout Flares: The most common adverse reactions reported in the clinical trial with colchicine tablets for treatment of gout flares were diarrhea (23%) and pharyngolaryngeal pain (3%).
FMF: Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating colchicine tablets, usually presenting within 24 hours, and occurring in up to 20% of patients given therapeutic doses.
Typical symptoms include cramping, nausea, diarrhea, abdominal pain and vomiting.
These events should be viewed as dose-limiting if severe, as they can herald the onset of more significant toxicity.
• Prophylaxis of Gout Flares: The most commonly reported adverse reaction in clinical trials for the prophylaxis of gout was diarrhea.
• Treatment of Gout Flares: The most common adverse reactions reported in the clinical trial for gout were diarrhea (23%) and pharyngolaryngeal pain (3%).
• FMF: Most common adverse reactions (up to 20%) are abdominal pain, diarrhea, nausea and vomiting.
These effects are usually mild, transient and reversible upon lowering the dose ( Error! Hyperlink reference not valid.
To report SUSPECTED ADVERSE REACTIONS, contact Dr.
5 WARNINGS AND PRECAUTIONS • Fatal overdoses have been reported with colchicine in adults and children.
Keep colchicine tablets out of the reach of children ( Error! Hyperlink reference not valid.
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• Blood dyscrasias: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia and aplastic anemia have been reported ( Error! Hyperlink reference not valid.
• Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine ( Error! Hyperlink reference not valid.
Like all medications, Colchicine 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: