DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Welchol (Colesevelam) - Side Effect Reports to FDA

 
 



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 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 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

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

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 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 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 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 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 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 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 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 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)

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012