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This document outlines essential safety information and warnings related to the use of colchicine. It is crucial to understand these potential risks and precautions to ensure safe use. Consult your healthcare provider if you have any questions or concerns.

• Risk of Overdose: Colchicine overdoses can be fatal, whether accidental or intentional, for both adults and children. Always follow your healthcare provider's dosing instructions and keep the medication out of children’s reach. Signs of an overdose include stomach pain, nausea, vomiting, and diarrhea, which can lead to dehydration. In case of an overdose, contact the Poison Control Center at 1-800-222-1222 or seek immediate medical assistance.

• Blood Cell Issues: Colchicine can affect your body's ability to produce new blood cells, even at prescribed doses. This condition can become serious if not addressed promptly. Regular lab tests are important. Notify your healthcare provider if you experience unusual bleeding, bruising, persistent fever, or fatigue.

• Drug and Food Interactions: Colchicine can interact with many other drugs, potentially increasing its levels to dangerous amounts. Notable interacting drugs include calcium channel blockers, digoxin, statins, certain antifungals, HIV protease inhibitors, and cyclosporine. Ensure your healthcare provider is aware of all medications you are taking, even if colchicine is used occasionally. Dosage adjustments may be necessary if taking interacting substances.

• Nerve and Muscle Toxicity: Prolonged use of colchicine can lead to nerve or muscle damage, with potential to cause rhabdomyolysis, a condition where damaged muscle tissue releases harmful proteins into the bloodstream. This risk is heightened by concurrent use of statins, fibrates, or cyclosporine, as well as in individuals with poor kidney function or older adults. Seek medical attention if you experience muscle pain, dark urine, or difficulty moving limbs, as stopping colchicine may be required. Symptoms usually resolve within a week after discontinuation, though in some cases, it may take longer.

• Contraindications: Avoid using colchicine if you have kidney or liver disease in combination with other interacting medications. Consult your healthcare provider if this applies to you before starting the medication.

Always discuss any concerns or questions with your healthcare provider to ensure safe and effective use of colchicine.

Common side effects:

• Diarrhea
• Nausea

Less common but important to monitor:

• Tiredness
• Headache
• Throat pain

Serious side effects:

• Allergic reaction symptoms
• Rash
• Itching
• Hives
• Swelling of the face, lips, tongue, or throat
• Symptoms of an infection
• Fever
• Chills
• Persistent sore throat
• Difficulty in urination
• Unusual weakness
• Muscle pain
• Changes in urine color
• Unusual bleeding or bruising
• Pain, tingling, or numbness in extremities

Interactions with high risk of serious adverse effects and should be avoided:

• Clarithromycin
• Erythromycin
• Digoxin
• Gemfibrozil
• Pravastatin
• Simvastatin

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Atazanavir
• Itraconazole
• Ketoconazole
• diltiazem
• Ritonavir
• telithromycin
• Verapamil