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Colcrys (Colchicine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Colcrys (Colchicine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (241)
Death (2)
Life Threatening Events (1)
Disability (2)

Reports by Reaction Type

Diarrhoea (82)Drug Ineffective (62)Nausea (22)Hypoaesthesia (20)Dizziness (18)Paraesthesia (18)Off Label Use (16)Abdominal Pain Upper (14)Rash (12)Insomnia (12)Dyspnoea (11)Drug Effect Decreased (11)

Below are a few examples of reports where side effects / adverse reactions may be related to Colcrys (Colchicine). For a complete list or a specific selection of reports, please use the links above.

Possible Colcrys side effects in 47 year old male

Reported by a physician from United States on 2012-08-27

Patient: 47 year old male

Reactions: Road Traffic Accident, Judgement Impaired

Drug(s) suspected as cause:
Colcrys



Possible Colcrys side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male

Reactions: Joint Effusion, Monarthritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    Indication: Gout
    Start date: 2012-03-09

Colcrys
    Indication: Gout
    Start date: 2012-03-09



Possible Colcrys side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 76 year old female, weighing 60.4 kg (132.8 pounds)

Reactions: Diarrhoea, Asthenia, Feeling Abnormal

Drug(s) suspected as cause:
Allopurinol
    Indication: Blood Uric Acid Increased
    Start date: 2011-09-01

Colcrys
    Indication: Blood Uric Acid Increased
    Start date: 2011-09-01

Niaspan
    Indication: Blood Cholesterol
    Start date: 2011-09-01

Other drugs received by patient: Crestor



Possible Colcrys side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-27

Patient: male, weighing 78.1 kg (171.8 pounds)

Reactions: Diarrhoea, Cough

Drug(s) suspected as cause:
Colchicine
    Administration route: Oral
    Indication: Gout
    Start date: 1972-01-01
    End date: 2012-04-01

Colchicine
    Indication: Familial Mediterranean Fever

Colcrys
    Administration route: Oral
    Indication: Gout
    Start date: 2012-05-01

Colcrys
    Administration route: Oral
    Indication: Familial Mediterranean Fever
    Start date: 2012-04-01
    End date: 2012-05-01

Other drugs received by patient: Potassium Chloride; Furosemide; Aspirin; Plavix; Coreg



Possible Colcrys side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient:

Reactions: International Normalised Ratio Increased, Drug Interaction

Drug(s) suspected as cause:
Colcrys
    Indication: Product Used FOR Unknown Indication

Coumadin
    Indication: Product Used FOR Unknown Indication



Possible Colcrys side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: male, weighing 86.3 kg (189.8 pounds)

Reactions: Tongue Discolouration, Dysphagia, Dyspnoea, Pain in Extremity, Hypoaesthesia, Paraesthesia, Abdominal Pain Upper, Oral Discomfort, Haematochezia, Diarrhoea, Throat Irritation, Dyspepsia, Insomnia, Tooth Disorder, Asthenia

Drug(s) suspected as cause:
Colcrys



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 male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: male, weighing 74.9 kg (164.8 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Colcrys
    Administration route: Oral
    Start date: 2012-04-16
    End date: 2012-04-22

Colcrys
    Administration route: Oral
    Indication: Gout
    Start date: 2012-04-15
    End date: 2012-04-16

Other drugs received by patient: Aleve; Cardizem; Coumadin



Possible Colcrys side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Colcrys



Possible Colcrys side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: male, weighing 122.6 kg (269.7 pounds)

Reactions: Drug Effect Decreased, Diarrhoea, Nausea

Drug(s) suspected as cause:
Colcrys
    Administration route: Oral
    Start date: 2012-04-09

Colcrys
    Administration route: Oral
    Indication: Gout
    Start date: 2011-09-01
    End date: 2011-09-01

Other drugs received by patient: Multi-Vitamin; Aspirin



Possible Colcrys side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: female

Reactions: Diarrhoea, Nausea

Drug(s) suspected as cause:
Colcrys
    Indication: Gout
    Start date: 2012-03-01

Colcrys
    Start date: 2012-01-01



Possible Colcrys side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: male

Reactions: Drug Effect Decreased, Diarrhoea, Nausea

Drug(s) suspected as cause:
Colcrys

Other drugs received by patient: Carvedilol; Hydrochlorothiazide



Possible Colcrys side effects in 75 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: 75 year old female

Reactions: Foot Deformity, Drug Ineffective

Drug(s) suspected as cause:
Colcrys



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 male

Reported by a physician from United States on 2012-07-26

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Colcrys



Possible Colcrys side effects in 71 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: 71 year old female

Reactions: Diverticulum, Diarrhoea, Blood Creatinine Increased

Drug(s) suspected as cause:
Colcrys
    Administration route: Oral
    Indication: Gout
    Start date: 2011-01-01

Uloric
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-04-10



Possible Colcrys side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: LIP Swelling, Diarrhoea, Dizziness, Abdominal Pain Upper

Drug(s) suspected as cause:
Colcrys

Other drugs received by patient: Aspirin; ^water Pill^; Calcium Carbonate; Hectorol; Hydrea; Pravastatin



Possible Colcrys side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: male, weighing 106.7 kg (234.7 pounds)

Reactions: Drug Effect Decreased, Diarrhoea

Drug(s) suspected as cause:
Colcrys
    Administration route: Oral
    Start date: 2012-06-15
    End date: 2012-06-15

Colcrys
    Administration route: Oral
    Indication: Gout
    Start date: 2012-06-16

Other drugs received by patient: Metoprolol Succinate



Possible Colcrys side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: male

Reactions: Hepatic Enzyme Increased

Drug(s) suspected as cause:
Colcrys

Other drugs received by patient: Unspecified Statin



Possible Colcrys side effects in 59 year old male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: 59 year old male, weighing 97.6 kg (214.7 pounds)

Reactions: Hypoaesthesia, Paraesthesia

Drug(s) suspected as cause:
Cephalexin
    Administration route: Oral
    Indication: Joint Swelling
    Start date: 2012-04-25

Colcrys
    Administration route: Oral
    Indication: Joint Swelling
    Start date: 2012-04-25
    End date: 2012-05-03



Possible Colcrys side effects in 82 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: 82 year old female

Reactions: Diarrhoea

Drug(s) suspected as cause:
Colcrys



Possible Colcrys side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Colcrys



Possible Colcrys side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Colcrys



Possible Colcrys side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: male, weighing 73.1 kg (160.8 pounds)

Reactions: Musculoskeletal Stiffness, Joint Stiffness

Drug(s) suspected as cause:
Colcrys
    Administration route: Oral
    Start date: 2012-05-06
    End date: 2012-05-08

Colcrys
    Administration route: Oral
    Indication: Gout
    Start date: 2012-03-01
    End date: 2012-05-05

Other drugs received by patient: Indomethacin CAP; Magnesium Oxide 420 MG; Losartan Potassium; Potassium Chloride; Indomethacin CAP; Methocarbamol



Possible Colcrys side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: male, weighing 63.6 kg (139.8 pounds)

Reactions: Abdominal Pain Upper

Drug(s) suspected as cause:
Colcrys

Other drugs received by patient: Lovastatin; Hydrochlorothiazide; Symbicort; Aspirin; Allopurinol; Folic Acid; Aspirin; Lisinopril



Possible Colcrys side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: female

Reactions: Nausea, Dizziness, Asthenia

Drug(s) suspected as cause:
Colcrys



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 76 year old male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: 76 year old male

Reactions: Muscular Weakness, Hypoaesthesia

Drug(s) suspected as cause:
Colcrys



Possible Colcrys side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: male, weighing 77.2 kg (169.8 pounds)

Reactions: Myalgia

Drug(s) suspected as cause:
Colcrys
    Administration route: Oral
    Indication: Gout
    Start date: 2012-04-09
    End date: 2012-04-01

Colcrys
    Administration route: Oral
    Start date: 2012-05-16

Other drugs received by patient: Allopurinol; Vitamin D



Possible Colcrys side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: male, weighing 78.5 kg (172.8 pounds)

Reactions: Dyspepsia, Chest Pain, Eructation

Drug(s) suspected as cause:
Colcrys

Other drugs received by patient: Stalevo 100; Zoloft; Allopurinol; Klonipine

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