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Welchol Side Effects

Generic Name: colesevelam

Note: This document contains side effect information about colesevelam. Some of the dosage forms listed on this page may not apply to the brand name Welchol.

In Summary

Common side effects of Welchol include: constipation. Other side effects include: dyspepsia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to colesevelam: oral powder for suspension, oral tablet

Along with its needed effects, colesevelam (the active ingredient contained in Welchol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking colesevelam:

Less common Incidence not known
  • Bleeding after defecation
  • darkened urine
  • difficulty with swallowing
  • indigestion
  • pain or discomfort in the chest
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pressure in the stomach
  • severe stomach pain
  • swelling of the abdominal or stomach area
  • unable to swallow saliva
  • uncomfortable swelling around the anus
  • yellow eyes or skin

Some side effects of colesevelam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • bloating
  • constipation
  • full or bloated feeling
  • heartburn
  • pain or cramping in the abdomen or stomach
  • stomach discomfort, upset, or pain
Less common
  • Lack or loss of strength
  • sneezing
  • stuffy nose

For Healthcare Professionals

Applies to colesevelam: oral powder for reconstitution, oral tablet

General

The most frequently reported side effects were constipation, dyspepsia, and nausea.[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 11%), flatulence
Common (1% to 10%): Dyspepsia, nausea, vomiting, diarrhea, abdominal pain, abnormal stools, abdominal distension
Uncommon (0.1% to 1%): Dysphagia
Very rare (less than 0.01%): Pancreatitis
Frequency not reported: Intestinal obstruction
Postmarketing reports: Bowel obstruction, esophageal obstruction, fecal impaction, exacerbation of hemorrhoids[Ref]

Metabolic

Common (1% to 10%): Hypertriglyceridemia, hypoglycemia[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, myocardial infarction, aortic stenosis, bradycardia[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, rhinitis, nasopharyngitis, upper respiratory tract infection[Ref]

Other

Common (1% to 10%): Accidental injury, asthenia, flu syndrome/influenza, fatigue, creatine phosphokinase increased
Uncommon (0.1% to 1%): Serum transaminases increased[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, back pain[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Hypersensitivity

In clinical trials of type 2 diabetes, patient who received this drug as an add on to a sulfonylurea discontinued the trial due to body rash and mouth blistering that occurred on the first day of therapy.[Ref]

Frequency not reported: Hypersensitivity reaction[Ref]

References

1. "Product Information. Welchol (colesevelam)" Daiichi Sankyo, Inc., Parsippany, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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