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Index of reports
> Cases with Off Label Use (16)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Colcrys (Colchicine) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Colcrys side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: 47 year old female
Reactions: Off Label Use, Drug Interaction, Rash
Drug(s) suspected as cause:
Amoxicillin
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-08
Colcrys
Indication: Leukocytoclastic Vasculitis
Start date: 2012-06-01
Possible Colcrys side effects in female
Reported by a individual with unspecified qualification from United States on 2012-07-26
Patient: female
Reactions: Off Label Use, Nausea
Drug(s) suspected as cause:
Colcrys
Administration route: Oral
Indication: Behcet's Syndrome
Start date: 2012-03-27
Prednisone
Administration route: Oral
Indication: Autoimmune Disorder
Start date: 2012-04-02
Prednisone
Administration route: Oral
Start date: 2012-03-28
End date: 2012-03-30
Prednisone
Administration route: Oral
Start date: 2012-03-31
End date: 2012-04-01
Other drugs received by patient: Claritin (Childrens)
Possible Colcrys side effects in female
Reported by a individual with unspecified qualification from United States on 2012-07-26
Patient: female, weighing 65.8 kg (144.8 pounds)
Reactions: Pharyngeal Inflammation, Glossodynia, Oral Discomfort, Off Label Use, Throat Irritation, Dyspepsia, Dysphonia, Diarrhoea, Laryngeal Inflammation, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Colcrys
Other drugs received by patient: Synthroid; Enablex; Plaquenil; Xanax; Prednisone; Toprol-XL
Possible Colcrys side effects in female
Reported by a individual with unspecified qualification from United States on 2012-05-10
Patient: female, weighing 54.5 kg (119.9 pounds)
Reactions: Off Label Use, Chest Discomfort, Dyspnoea, Pericarditis, Chest Pain, Pyrexia, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Colchicine
Administration route: Oral
Indication: Behcet's Syndrome
Start date: 2001-01-01
End date: 2011-01-01
Colcrys
Administration route: Oral
Indication: Behcet's Syndrome
Start date: 2011-01-01
Other drugs received by patient: Dapsone; Omeprazole
Possible Colcrys side effects in female
Reported by a individual with unspecified qualification from United States on 2012-02-15
Patient: female
Reactions: Off Label Use, Intraocular Pressure Increased
Drug(s) suspected as cause:
Colcrys
Administration route: Oral
Indication: Pericarditis
Start date: 2012-02-01
Colcrys
Administration route: Oral
Start date: 2011-04-01
End date: 2012-02-01
Prednisone TAB
Administration route: Oral
Indication: Pericarditis
Start date: 2010-01-01
End date: 2011-01-01
Other drugs received by patient: Timolol Maleate
Possible Colcrys side effects in female
Reported by a individual with unspecified qualification from United States on 2012-02-03
Patient: female, weighing 65.4 kg (143.8 pounds)
Reactions: Agitation, Urinary Tract Infection, Mental Status Changes, Delirium, Ammonia Decreased, Amnesia, Convulsion, Off Label Use, Psychotic Disorder, Respiratory Failure, Hydrocephalus, Cerebral Cyst, Myocardial Infarction, Complex Partial Seizures, White Blood Cell Count Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clarithromycin
Administration route: Oral
Indication: Skin Ulcer
Start date: 2011-12-06
End date: 2011-12-14
Colcrys
Administration route: Oral
Indication: Oedema Peripheral
Start date: 2011-08-01
End date: 2011-09-01
Indomethacin
Administration route: Oral
Indication: Oedema Peripheral
Start date: 2011-08-01
End date: 2011-09-01
Other drugs received by patient: Synthroid; Metoprolol; Lasix
Possible Colcrys side effects in 64 year old male
Reported by a physician from United States on 2012-01-30
Patient: 64 year old male
Reactions: Off Label Use, Diarrhoea
Drug(s) suspected as cause:
Colcrys
Other drugs received by patient: Nsaid
Possible Colcrys side effects in male
Reported by a individual with unspecified qualification from United States on 2012-01-30
Patient: male, weighing 72.6 kg (159.8 pounds)
Reactions: Off Label Use, Fatigue, Exercise Tolerance Decreased
Drug(s) suspected as cause:
Colcrys
Other drugs received by patient: None
Possible Colcrys side effects in 64 year old male
Reported by a physician from United States on 2012-01-30
Patient: 64 year old male
Reactions: Off Label Use, Diarrhoea
Drug(s) suspected as cause:
Colcrys
Other drugs received by patient: Nsaid
Possible Colcrys side effects in male
Reported by a individual with unspecified qualification from United States on 2012-01-30
Patient: male, weighing 72.6 kg (159.8 pounds)
Reactions: Off Label Use, Fatigue, Exercise Tolerance Decreased
Drug(s) suspected as cause:
Colcrys
Other drugs received by patient: None
Possible Colcrys side effects in female
Reported by a individual with unspecified qualification from United States on 2012-01-19
Patient: female, weighing 65.4 kg (143.8 pounds)
Reactions: Agitation, Urinary Tract Infection, Mental Status Changes, Delirium, Amnesia, Ammonia Decreased, Convulsion, Off Label Use, Psychotic Disorder, Respiratory Failure, Hydrocephalus, Myocardial Infarction, Cerebral Cyst, Complex Partial Seizures, White Blood Cell Count Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Biaxin
Administration route: Oral
Indication: Skin Ulcer
Start date: 2011-12-06
End date: 2011-12-14
Colcrys
Administration route: Oral
Indication: Oedema Peripheral
Start date: 2011-08-01
End date: 2011-09-01
Indomethacin
Administration route: Oral
Indication: Oedema Peripheral
Start date: 2011-08-01
End date: 2011-09-01
Other drugs received by patient: Lasix; Synthroid; Metoprolol Tartrate
Possible Colcrys side effects in male
Reported by a individual with unspecified qualification from United States on 2011-10-26
Patient: male, weighing 81.7 kg (179.8 pounds)
Reactions: Off Label Use, Malaise, Muscular Weakness, Headache, Memory Impairment
Drug(s) suspected as cause:
Colchicine
Administration route: Oral
Indication: Pericarditis
Start date: 2011-04-01
End date: 2011-07-01
Colcrys
Administration route: Oral
Indication: Pericarditis
Start date: 2011-07-01
End date: 2011-08-20
Colcrys
Indication: Insomnia
Other drugs received by patient: Ibuprofen
Possible Colcrys side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-26
Patient: male, weighing 84.0 kg (184.8 pounds)
Reactions: Off Label Use, Diarrhoea
Drug(s) suspected as cause:
Colcrys
Administration route: Oral
Indication: Pericarditis
Start date: 2011-03-04
End date: 2011-06-14
Colcrys
Administration route: Oral
Start date: 2011-02-11
End date: 2011-02-12
Other drugs received by patient: Plavix; Pradaxa; Lasix; Coreg; Hydrocodone 5 MG / 325 MG; Isorbide; Lisinopril; Prednisone; Aspirin; Multaq
Possible Colcrys side effects in male
Reported by a individual with unspecified qualification from United States on 2011-10-26
Patient: male, weighing 86.3 kg (189.8 pounds)
Reactions: Off Label Use, Urticaria
Drug(s) suspected as cause:
Colcrys
Other drugs received by patient: Fioricet; Niaspan; Clonazepam; Toprol-XL; Zoloft; Aspirin
Possible Colcrys side effects in female
Reported by a individual with unspecified qualification from United States on 2011-10-26
Patient: female, weighing 68.1 kg (149.8 pounds)
Reactions: Off Label Use, Alopecia, Paraesthesia
Drug(s) suspected as cause:
Colcrys
Administration route: Oral
Start date: 2011-06-08
Colcrys
Administration route: Oral
Indication: Pericarditis
Start date: 2011-05-11
End date: 2011-06-07
Other drugs received by patient: Omeprazole; Prednisone
Possible Colcrys side effects in 63 year old female
Reported by a consumer/non-health professional from United States on 2011-10-26
Patient: 63 year old female
Reactions: Off Label Use, Leukopenia
Drug(s) suspected as cause:
Colcrys
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