This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Welchol (Colesevelam) 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 (58)
Life Threatening Events (2)
Disability (3)
Reports by Reaction Type
Constipation (11),
Weight Decreased (8),
Off Label Use (6),
Dizziness (6),
Gastrointestinal Pain (6),
Diarrhoea (6),
Bronchial Secretion Retention (5),
Headache (5),
Treatment Noncompliance (5),
Nausea (5),
Drug Hypersensitivity (5),
Incorrect Drug Administration Duration (5)
Below are a few examples of reports where side effects / adverse reactions may be related to Welchol (Colesevelam). For a complete list or a specific selection of reports, please use the links above.
Possible Welchol side effects in
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient:
Reactions: Drug Ineffective, Pain in Extremity, Asthenia
Drug(s) suspected as cause:
Zetia
Dosage: 10 mg, qd
Administration route: Oral
Indication: Blood Cholesterol Increased
Start date: 2010-01-01
Welchol
Indication: Blood Cholesterol Increased
Other drugs received by patient: Vagifem
Possible Welchol side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Welchol
Dosage: 625 mg, bid
Administration route: Oral
Celebrex
Nasonex
Dosage: unk
Tricor
Vioxx
Possible Welchol side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: male
Reactions: Flushing, Fatigue
Drug(s) suspected as cause:
Niaspan
Dosage: at bedtime
Administration route: Oral
Indication: Blood Triglycerides Increased
Welchol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Aspirin; OTC NON Flush Niacin; Livalo; Unknown Hypertension Medication
Possible Welchol side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: female
Reactions: Myalgia
Drug(s) suspected as cause:
Niaspan
Indication: Product Used FOR Unknown Indication
Welchol
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Oxybutynin; Cozaar
Possible Welchol side effects in
Reported by a physician from United States on 2012-08-01
Patient:
Reactions: Intestinal Obstruction
Drug(s) suspected as cause:
Welchol
Possible Welchol side effects in 48 year old male
Reported by a individual with unspecified qualification from United States on 2012-07-27
Patient: 48 year old male, weighing 86.2 kg (189.6 pounds)
Reactions: Colitis, Abdominal Pain Upper
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Welchol
Possible Welchol side effects in 38 year old female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: 38 year old female, weighing 86.0 kg (189.2 pounds)
Reactions: Weight Decreased, Pyoderma Gangrenosum, Conjunctivitis, Crohn's Disease, Female Genital Tract Fistula, Tremor, Cholelithiasis, Fungal Infection, Arthralgia, Fibromyalgia, Abscess, Adhesion, Rectal Abscess, Arthritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Welchol
Dosage: 1875 mg (625 mg,tid), per oral; 1250 mg (625 mg, bid, per oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Humira
Dosage: 40 mg (40 mg, biw), subcutaneous;
Indication: Crohn's Disease
Start date: 2009-01-01
End date: 2010-01-01
Humira
Dosage: 40 mg (40 mg, biw), subcutaneous;
Indication: Crohn's Disease
Start date: 2010-01-01
End date: 2010-08-01
Humira
Dosage: 40 mg (40 mg, biw), subcutaneous;
Indication: Crohn's Disease
Start date: 2010-11-05
Prednisone
Dosage: unk
Start date: 2012-02-01
Vancomycin
Dosage: unk
Indication: Infection Prophylaxis
Start date: 2008-01-01
End date: 2008-01-01
Other drugs received by patient: Flagyl; Cyanocobalamin; Fish OIL; Fentanyl; Zinc Oxide; Vigran (Ergocalciferol, Ascorbic Acid, Pyridoxine Hydrochloride, Thiam; Morphine; Zolpidem Tartrate
Possible Welchol side effects in 80 year old female
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: 80 year old female, weighing 79.4 kg (174.6 pounds)
Reactions: Nausea, Headache
Drug(s) suspected as cause:
Welchol
Possible Welchol side effects in 34 year old male
Reported by a individual with unspecified qualification from United States on 2012-07-10
Patient: 34 year old male, weighing 88.5 kg (194.6 pounds)
Reactions: Vomiting
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Welchol
Dosage: 625 1/day po
Administration route: Oral
Indication: Blood Cholesterol Increased
Start date: 2012-07-03
End date: 2012-07-04
Welchol
Dosage: 625 1/day po
Administration route: Oral
Indication: Blood Glucose Increased
Start date: 2012-07-03
End date: 2012-07-04
Welchol
Dosage: 625 1/day po
Administration route: Oral
Indication: Blood Triglycerides Increased
Start date: 2012-07-03
End date: 2012-07-04
Other drugs received by patient: Vitmains; Trilipix; Aciphex; Unisom
Possible Welchol side effects in 54 year old male
Reported by a individual with unspecified qualification from United States on 2012-07-05
Patient: 54 year old male, weighing 87.5 kg (192.6 pounds)
Reactions: Weight Decreased, Coeliac Disease, Diarrhoea, Dehydration
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Benicar HCT
Dosage: 40/12.5mg (qd),per oral ; 1/2 (40/12.5mg) tablet (1/2 (40/12.5mg) tablet qd),per oral
Administration route: Oral
Indication: Hypertension
End date: 2012-01-01
Benicar HCT
Dosage: 40/12.5mg (qd),per oral ; 1/2 (40/12.5mg) tablet (1/2 (40/12.5mg) tablet qd),per oral
Administration route: Oral
Indication: Hypertension
Start date: 2012-06-20
Welchol
Dosage: 3750 mg (1250 mg,tid),per oral
Administration route: Oral
Indication: Diarrhoea
Start date: 2012-01-01
Welchol
Dosage: 3750 mg (1250 mg,tid),per oral
Administration route: Oral
Indication: Blood Cholesterol Increased
Start date: 2012-01-01
Other drugs received by patient: Xanax; Lipitor; Prozac (Fluoxetine) (Fluoxetine)
Possible Welchol side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: female
Reactions: Dyspepsia, Oropharyngeal Pain
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Welchol
Other drugs received by patient: Nexium; Prinpro; Zestril
Possible Welchol side effects in 56 year old male
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: 56 year old male, weighing 190.5 kg (419.1 pounds)
Reactions: Oral Pain, Tongue Blistering
Drug(s) suspected as cause:
Welchol
Dosage: 1300 mg bid po
Administration route: Oral
Indication: Diarrhoea
Start date: 2012-06-15
End date: 2012-06-30
Welchol
Dosage: 1300 mg bid po
Administration route: Oral
Indication: Pain
Start date: 2012-06-15
End date: 2012-06-30
Possible Welchol side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-07-02
Patient: 62 year old female
Reactions: Bronchial Secretion Retention, Constipation, Treatment Noncompliance, Off Label Use, Incorrect Drug Administration Duration, Gastrointestinal Pain, Disease Recurrence, Bronchitis
Drug(s) suspected as cause:
Welchol
Dosage: 625 mg, unk
Indication: Blood Cholesterol Increased
Start date: 2012-04-27
Prevacid 24 HR
Dosage: 15 mg, qd
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2011-08-01
Other drugs received by patient: Vitamins NOS
Possible Welchol side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-28
Patient: female, weighing 39.0 kg (85.9 pounds)
Reactions: Pyoderma Gangrenosum, Weight Decreased, Ileostomy, Injection Site Haematoma, Drug Ineffective, Pain, Anal Fistula, Fibromyalgia, Adhesion, Rectal Abscess, Inappropriate Schedule of Drug Administration, Subcutaneous Abscess, Crohn's Disease, Incorrect Dose Administered, Joint Dislocation, Injection Site Pain, Female Genital Tract Fistula, Tremor, Anxiety, Cholelithiasis, Renal Failure, Arthralgia, Conjunctivitis Infective, Fungal Skin Infection, Arthritis
Drug(s) suspected as cause:
Humira
Indication: Crohn's Disease
Welchol
Indication: Product Used FOR Unknown Indication
Humira
End date: 2010-08-01
Humira
Start date: 2010-11-05
End date: 2011-10-01
Humira
Start date: 2009-01-01
Other drugs received by patient: Vitamin B-12; Benefiber; Prednisone TAB; Multi-Vitamin; Ambien; Probiotic; Vitamin D; Oxycodone HCL; Morphine; Fish OIL; Prednisone TAB; Prilosec; Fentanyl-100; Zinc Sulfate; Vancomycin; Anti-Diarrheal
Possible Welchol side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-28
Patient: female
Reactions: Gastrointestinal Pain, Nausea, Nervousness
Drug(s) suspected as cause:
Lyrica
Dosage: unk
Administration route: Oral
End date: 2012-06-01
Lyrica
Dosage: 50 mg, 3x/day
Administration route: Oral
Indication: Neuralgia
Start date: 2008-01-01
Lyrica
Dosage: reduced dose
Administration route: Oral
Start date: 2012-04-01
Welchol
Dosage: unk
Indication: Diarrhoea
Possible Welchol side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient: 62 year old female
Reactions: Off Label Use, Gastrointestinal Pain, Incorrect Drug Administration Duration, Disease Recurrence, Bronchial Secretion Retention, Bronchitis, Constipation, Treatment Noncompliance
Drug(s) suspected as cause:
Prevacid 24 HR
Dosage: 15 mg, qd
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2011-08-01
Welchol
Dosage: 625 mg, unk
Indication: Blood Cholesterol Increased
Start date: 2012-04-27
Other drugs received by patient: Vitamins NOS
Possible Welchol side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: 62 year old female
Reactions: Bronchial Secretion Retention, Constipation, Treatment Noncompliance, Off Label Use, Gastrointestinal Pain, Incorrect Drug Administration Duration, Disease Recurrence, Bronchitis
Drug(s) suspected as cause:
Prevacid 24 HR
Dosage: 15 mg, qd
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2011-08-01
Welchol
Dosage: 625 mg, unk
Indication: Blood Cholesterol Increased
Start date: 2012-04-27
Other drugs received by patient: Vitamins NOS
Possible Welchol side effects in 73 year old male
Reported by a individual with unspecified qualification from United States on 2012-06-13
Patient: 73 year old male, weighing 109.8 kg (241.5 pounds)
Reactions: Neuropathy Peripheral, Chest Discomfort, Pain in Extremity, Diarrhoea, Muscle Spasms, Venous Occlusion, Arrhythmia
Drug(s) suspected as cause:
Welchol
Dosage: per oral
Administration route: Oral
Indication: Bile Acid Malabsorption
Azor
Dosage: 5/40mg (qd), per oral
Administration route: Oral
Indication: Hypertension
Start date: 2012-03-01
Tribenzor
Dosage: per oral
Administration route: Oral
Indication: Hypertension
End date: 2012-03-01
Other drugs received by patient: Simvastatin; Benicar
Possible Welchol side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-05
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Tricor
Dosage: unk
Celebrex
Dosage: unk
Welchol
Dosage: 625 mg, 2x/day
Administration route: Oral
Nasonex
Dosage: unk
Vioxx
Dosage: unk
Possible Welchol side effects in female
Reported by a individual with unspecified qualification from United States on 2012-06-04
Patient: female, weighing 64.9 kg (142.7 pounds)
Reactions: Arthropathy, Fatigue, Vision Blurred
Drug(s) suspected as cause:
Welchol
Crestor
Possible Welchol side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-30
Patient: male
Reactions: Multi-Organ Failure, Malaise, Cardiac Failure, Immobile
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Lasix
Dosage: 40 mg
Indication: Cardiac Disorder
Advair Diskus 250 / 50
Dosage: inh
Indication: Chronic Obstructive Pulmonary Disease
Welchol
Dosage: 625 mg
Indication: Gastrointestinal Disorder
Nexium
Dosage: 40 mg
Indication: Gastrooesophageal Reflux Disease
Verapamil
Dosage: 360 mg
Indication: Cardiac Disorder
Coumadin
Dosage: 5 mg
Indication: Cardiac Disorder
Spiriva
Indication: Chronic Obstructive Pulmonary Disease
Nitrostat
Dosage: 0.4 mg
Indication: Cardiac Disorder
Toprol-XL
Dosage: 100 mg
Indication: Cardiac Disorder
Toviaz
Dosage: 8 mg
Indication: Bladder Disorder
Digoxin
Dosage: 0.125 mg
Indication: Cardiac Disorder
Possible Welchol side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-23
Patient: male
Reactions: Multi-Organ Failure, Malaise, General Physical Health Deterioration, Immobile, Cardiac Disorder
Drug(s) suspected as cause:
Advair Diskus 100 / 50
Indication: Chronic Obstructive Pulmonary Disease
Welchol
Dosage: 625mg unknown
Indication: Gastrointestinal Disorder
Coumadin
Dosage: 5mg unknown
Indication: Cardiac Disorder
Digoxin
Dosage: .125mg unknown
Indication: Cardiac Disorder
Nitrostat
Dosage: .4mg unknown
Indication: Cardiac Disorder
Toprol-XL
Dosage: 100mg unknown
Indication: Cardiac Disorder
Toviaz
Dosage: 8mg unknown
Indication: Bladder Disorder
Nexium
Dosage: 40mg unknown
Indication: Gastrooesophageal Reflux Disease
Spiriva
Indication: Chronic Obstructive Pulmonary Disease
Verapamil
Dosage: 360mg unknown
Indication: Cardiac Disorder
Lasix
Dosage: 40mg unknown
Indication: Cardiac Disorder
Possible Welchol side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: 62 year old female
Reactions: Off Label Use, Incorrect Drug Administration Duration, Gastrointestinal Pain, Disease Recurrence, Bronchial Secretion Retention, Bronchitis, Constipation, Treatment Noncompliance
Drug(s) suspected as cause:
Prevacid 24 HR
Dosage: 15 mg, qd
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2011-08-01
Welchol
Dosage: 625 mg, unk
Indication: Blood Cholesterol Increased
Start date: 2012-04-27
Other drugs received by patient: Vitamins NOS
Possible Welchol side effects in 62 year old female
Reported by a consumer/non-health professional from United States on 2012-05-21
Patient: 62 year old female
Reactions: Off Label Use, Gastrointestinal Pain, Incorrect Drug Administration Duration, Disease Recurrence, Bronchial Secretion Retention, Treatment Noncompliance, Constipation
Drug(s) suspected as cause:
Prevacid 24 HR
Dosage: 15 mg, qd
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2011-08-01
Welchol
Dosage: 625 mg, unk
Indication: Blood Cholesterol Increased
Start date: 2012-04-27
Other drugs received by patient: Vitamins NOS
Possible Welchol side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-16
Patient: male
Reactions: Multi-Organ Failure
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Welchol
Indication: Gastrointestinal Disorder
Advair Diskus 100 / 50
Dosage: 250/50
Indication: Chronic Obstructive Pulmonary Disease
Lasix
Indication: Cardiac Disorder
Spiriva
Indication: Chronic Obstructive Pulmonary Disease
Verapamil
Toprol-XL
Administration route: Oral
Indication: Cardiac Disorder
Nitrostat
Indication: Cardiac Disorder
Coumadin
Indication: Cardiac Disorder
Toviaz
Indication: Bladder Disorder
Digoxin
Indication: Cardiac Disorder
Possible Welchol side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-16
Patient: female, weighing 39.0 kg (85.9 pounds)
Reactions: Pyoderma Gangrenosum, Weight Decreased, Injection Site Haematoma, Drug Ineffective, Pain, Anal Fistula, Fibromyalgia, Adhesion, Rectal Abscess, Subcutaneous Abscess, Crohn's Disease, Injection Site Pain, Joint Dislocation, Female Genital Tract Fistula, Tremor, Anxiety, Cholelithiasis, Renal Failure, Conjunctivitis Infective, Arthralgia, Fungal Skin Infection, Arthritis
Drug(s) suspected as cause:
Humira
Indication: Crohn's Disease
Humira
Start date: 2009-01-01
Humira
End date: 2010-08-01
Humira
Start date: 2010-11-05
End date: 2011-10-01
Welchol
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Morphine; Prilosec; Ambien; Benefiber; Fentanyl-100; Oxycodone HCL; Fish OIL; Prednisone TAB; Anti-Diarrheal; Probiotic; Prilosec; Welchol; Vitamin B-12; Zinc Sulfate; Multi-Vitamin; Vancomycin; Oxycodone HCL; Prednisone TAB; Vitamin D
Possible Welchol side effects in 77 year old male
Reported by a consumer/non-health professional from United States on 2012-05-14
Patient: 77 year old male, weighing 86.2 kg (189.6 pounds)
Reactions: Rash
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Welchol
Possible Welchol side effects in 66 year old female
Reported by a consumer/non-health professional from United States on 2012-04-25
Patient: 66 year old female, weighing 88.0 kg (193.6 pounds)
Reactions: Pain in Extremity, Drug Ineffective, Drug Hypersensitivity
Drug(s) suspected as cause:
Lipitor
Dosage: unk
Administration route: Oral
Indication: Hypercholesterolaemia
Welchol
Dosage: unk
Indication: Blood Cholesterol Increased
Possible Welchol side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-25
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Nasonex
Dosage: unk
Tricor
Dosage: unk
Celebrex
Dosage: unk
Vioxx
Dosage: unk
Welchol
Dosage: 625 mg, 2x/day
Administration route: Oral
Possible Welchol side effects in female
Reported by a physician from United States on 2012-04-17
Patient: female
Reactions: Renal Failure
Drug(s) suspected as cause:
Welchol
Other drugs received by patient: ACE-I (Ace Inhibitor Nos)
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