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Colchicum Side Effects submitted to FDA
Total Colchicum reports: 28.Colchicum FDA safety alerts: No.
Reported deaths: 12 Reported hospitalizations: 27.
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FDA Reported Colchicum Side Effects: multi-organ failure, accidental overdose, intentional overdose, hypotension, diarrhoea, coagulopathy, sepsis, acute promyelocytic leukaemia, partial seizures, loss of consciousness, disseminated intravascular coagulation,
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Colchicum Side Effects Report #5660643-4
Physician from UNITED KINGDOM reported COLCHICUM problem on Feb 29, 2008. Male patient, 73 years of age, was diagnosed with gouty arthritis and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: rhabdomyolysis. COLCHICUM dosage: 1.5 MG, DAILY X 6 WEEKS, ORAL; 0.5 - 1 MG, DAILY, ORAL. During the same period patient was treated with COLCHICUM JTL LIQ, DIGOXIN, ALLOPURINOL, FUROSEMIDE, LISINOPRIL, ISOSORBIDE MONONITRATE, WARFARIN, METOLAZONE. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5676001-2
COLCHICUM problem was reported by a Physician from UNITED STATES on Feb 29, 2008. Female patient was diagnosed with back pain and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: accidental overdose, cardiac arrest. COLCHICUM dosage: 16 MG, QOD, INTRAVENOUS. Patient died on 03/20/2007.
Colchicum Side Effects Report #5676002-4
Physician from UNITED STATES reported COLCHICUM problem on Feb 29, 2008. Female patient, 56 years of age, was diagnosed with fibromyalgia, neck pain and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: accidental overdose, cardiac arrest, therapeutic agent toxicity. COLCHICUM dosage: 16 MG, 1/WEEK, INTRAVENOUS. During the same period patient was treated with COLCHICUM JTL LIQ. Patient died on 04/01/2006.
Colchicum Side Effects Report #5676006-1
COLCHICUM problem was reported by a Physician from UNITED STATES on Mar 07, 2008. Male patient, 59 years of age, was diagnosed with gout and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: rhabdomyolysis. COLCHICUM dosage: 0.6 MG, BID, ORAL. During the same period patient was treated with DIGOXIN, VERAPAMIL, ACETYLSALICYLIC ACID ENTERIC COATED, THEOPHYLLINE, METAPROTERENOL SULPHATE, IPRATROPIUM BROMIDE, TRIAMCINOLONE ACETONIDE, INDOMETHACIN. Patient was hospitalized. Patient recovered.

Colchicum Side Effects Report #5624864-9
Physician from UNITED STATES reported COLCHICUM problem on Jan 31, 2008. Female patient, 61 years of age, was diagnosed with bursitis, hypercholesterolaemia and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: rhabdomyolysis. COLCHICUM dosage: 0.6 MG, BID, ORAL. During the same period patient was treated with SIMVASTATIN, ASPIRIN, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5636205-1
COLCHICUM problem was reported by a Health Professional from ISRAEL on Feb 06, 2008. Male patient, 79 years of age, was diagnosed with gouty arthritis and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: rhabdomyolysis. COLCHICUM dosage: 1.5 MG, DAILY; ORAL. During the same period patient was treated with DIGOXIN, FUROSEMIDE, WARFARIN, ALLOPURINOL, BISOPROLOL FUMARATE, ELTROXIN, ISOSORBIDE MONONITRATE, ASPIRIN. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5613638-0
Health Professional from UNITED STATES reported COLCHICUM problem on Jan 16, 2008. Male patient, 79 years of age, was diagnosed with gout and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, pancreatitis acute, renal cyst, splenomegaly. COLCHICUM dosage: 1MG/DAILY;. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5550531-6
COLCHICUM problem was reported by a Physician from UNITED STATES on Nov 26, 2007. Male patient, 34 years of age, was diagnosed with behcet's syndrome and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: acute promyelocytic leukaemia, anaemia, aphthous stomatitis, ecchymosis, exercise tolerance decreased, haematuria, haemorrhagic diathesis, leukopenia, rash pustular. COLCHICUM dosage: 1 MG/DAY. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5573240-6
Physician from FRANCE reported COLCHICUM problem on Dec 13, 2007. Female patient, 45 years of age, was diagnosed with familial mediterranean fever and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: neuromyopathy, optic neuropathy. COLCHICUM dosage: 2 MG, DAILY; 1 MG, DAILY. During the same period patient was treated with COLCHICUM JTL LIQ. Patient was hospitalized. Patient recovered.

Colchicum Side Effects Report #5485482-9
COLCHICUM problem was reported by a Physician from TAIWAN, PROVINCE OF CHINA on Oct 02, 2007. Male patient, 48 years of age, was diagnosed with gouty arthritis and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: electrolyte imbalance, hypocalcaemia, hypomagnesaemia, hypophosphataemia, overdose, renal failure acute. COLCHICUM dosage: unknown. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5491843-4
Physician from UNITED STATES reported COLCHICUM problem on Oct 09, 2007. Male patient, 30 years of age, weighting 216.1 lb, was diagnosed with suicide attempt and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, circulatory collapse, completed suicide, intentional overdose. COLCHICUM dosage: 50 TABLETS,30MG(MAX DOSE 39.6MG), ORAL. Patient died on 01/01/2000.
Colchicum Side Effects Report #5500131-9
COLCHICUM problem was reported by a Consumer or non-health professional from AUSTRALIA on Oct 17, 2007. Male patient, 79 years of age, was diagnosed with gout and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: pancreatitis acute. COLCHICUM dosage: unknown. During the same period patient was treated with DILTIAZEM, VALACYCLOVIR, NICORANDIL, BISOPROLOL FUMARATE, DEFEROSIROX, FRUSEMIDE, GLYCERYL TRINITRATE. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5468219-9
Physician from TURKEY reported COLCHICUM problem on Sept 14, 2007. Female patient, child 3 years of age, was diagnosed with accident and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: accidental exposure, accidental overdose, disseminated intravascular coagulation, loss of consciousness, multi-organ failure, partial seizures. COLCHICUM dosage: 20-25 TABLETS(0.9MG/KG)MAXIMALLY, ORAL. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5473163-7
COLCHICUM problem was reported by a Health Professional from TURKEY on Sept 20, 2007. Male patient, 34 years of age, was diagnosed with behcet's syndrome and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: acute promyelocytic leukaemia. COLCHICUM dosage: 1 MG, DAILY. Patient was hospitalized. Patient recovered.

Colchicum Side Effects Report #5420605-9
Physician from GERMANY reported COLCHICUM problem on Aug 10, 2007. Male patient, 57 years of age, was diagnosed with ill-defined disorder, hypertension and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: hepatic failure, hypovolaemic shock, ileus paralytic, multi-organ failure, pancreatitis necrotising, pulmonary embolism, renal failure acute, respiratory distress, sepsis. COLCHICUM dosage: unknown. During the same period patient was treated with COVERSUM, RANITIC. Patient died on 11/12/2003.
Colchicum Side Effects Report #5420855-1
COLCHICUM problem was reported by a Physician from ISRAEL on Aug 07, 2007. Male patient, 53 years of age, weighting 163.1 lb, was diagnosed with familial mediterranean fever and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: haemorrhoidal haemorrhage, hepatic steatosis, microcytic anaemia, rectal haemorrhage. COLCHICUM dosage: unknown. During the same period patient was treated with ANGIOMAX, OMEPRAZOLE, MICROPIRIN, PLAVIX, NORMALOL, ENALAPRIL, SIMVASTATIN. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5729765-3
Health Professional from GERMANY reported COLCHICUM problem on Apr 25, 2008. Female patient, 24 years of age, was diagnosed with familial mediterranean fever and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: myopathy toxic, renal failure, rhabdomyolysis. COLCHICUM dosage: 1 MG, DAILY, ORAL. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5740284-0
COLCHICUM problem was reported by a Health Professional from TURKEY on May 02, 2008. Male patient, 30 years of age, was diagnosed with familial mediterranean fever, hyperlipidaemia and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: myopathy, polyneuropathy. COLCHICUM dosage: 1.5 MG, DAILY. During the same period patient was treated with SIMVASTATIN. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5741352-X
Health Professional from TURKEY reported COLCHICUM problem on May 02, 2008. Male patient, 41 years of age, was diagnosed with familial mediterranean fever, hyperlipidaemia and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: myopathy, polyneuropathy. COLCHICUM dosage: 1 MG, DAILY. During the same period patient was treated with ATORVASTATIN CALCIUM. Patient was hospitalized. Patient recovered.

Colchicum Side Effects Report #5725911-6
COLCHICUM problem was reported by a Health Professional from UNITED STATES on Apr 14, 2008. Female patient, 56 years of age, was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: chest pain, diarrhoea, infusion related reaction, vomiting. COLCHICUM dosage: 2MGX1X WEEKLY FOR 6 WEEKS. Patient was hospitalized. Patient died.
Colchicum Side Effects Report #5725914-1
Health Professional from UNITED STATES reported COLCHICUM problem on Apr 14, 2008. Female patient, 56 years of age, was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anuria, blood smear test abnormal, bradycardia, cardiac arrest, cardiotoxicity, chest pain, diarrhoea. COLCHICUM dosage: 2MGX1X WEEKLY FOR 6 WEEKS. Patient was hospitalized. Patient died.
Colchicum Side Effects Report #5725932-3
COLCHICUM problem was reported by a Health Professional from UNITED STATES on Apr 14, 2008. Female patient, 77 years of age, was diagnosed with back pain and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: abdominal pain, acidosis, cardiac arrest, cardiotoxicity, hepatic enzyme increased, hepatic function abnormal. COLCHICUM dosage: 2MG EVERY OTHER DAY FOR 6 DAY. Patient was hospitalized. Patient died.
Colchicum Side Effects Report #5350555-8
Consumer or non-health professional from UNITED STATES reported COLCHICUM problem on May 21, 2007. Male patient, 66 years of age, was diagnosed with gout and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: myopathy, ophthalmoplegia, paralysis flaccid, quadriplegia, sepsis. COLCHICUM dosage: 0.6 MG TWICE DAILY. Patient was hospitalized. Patient died.
Colchicum Side Effects Report #5371021-X
COLCHICUM problem was reported by a Physician from UNITED KINGDOM on June 14, 2007. Male patient, 65 years of age, was diagnosed with gout and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: multi-organ failure. COLCHICUM dosage: 1.5 MG, DAILY,. Patient died.
Colchicum Side Effects Report #5375709-6
Health Professional from NEW ZEALAND reported COLCHICUM problem on June 19, 2007. Male patient, 20 years of age, was diagnosed with completed suicide and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: abdominal pain, coagulopathy, diarrhoea, hypotension, hypoxia, intentional overdose, multi-organ failure, oliguria, tachycardia. COLCHICUM dosage: 40 MG, SINGLE, ORAL. Patient was hospitalized. Patient died.
Colchicum Side Effects Report #5375710-2
COLCHICUM problem was reported by a Health Professional from NEW ZEALAND on June 19, 2007. Male patient, 46 years of age, was diagnosed with intentional overdose, suicide attempt and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: hypotension, intentional overdose, metabolic acidosis. COLCHICUM dosage: unknown. During the same period patient was treated with COLCHICUM JTL LIQ, ALLOPURINOL, NAPROSYN. Patient was hospitalized. Patient recovered.
Colchicum Side Effects Report #5375714-X
Health Professional from NEW ZEALAND reported COLCHICUM problem on June 19, 2007. Male patient, 59 years of age, was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: accidental overdose, arrhythmia, cardiac arrest, poisoning, shock. COLCHICUM dosage: 18 MG, SINGLE, ORAL. Patient was hospitalized. Patient died.
Colchicum Side Effects Report #5376615-3
COLCHICUM problem was reported by a Health Professional from NEW ZEALAND on June 19, 2007. Female patient, 15 years of age, was diagnosed with completed suicide and was treated with COLCHICUM. After drug was administered, patient experienced the following problems/side effects: coagulopathy, diarrhoea, haemodialysis, multi-organ failure, overdose, vomiting. COLCHICUM dosage: 30 MG, SINGLE, ORAL. Patient was hospitalized. Patient died.
Colchicum Side Effects


