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Colesevelam Side Effects

In Summary

Commonly reported side effects of colesevelam 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

In addition to its needed effects, some unwanted effects may be caused by colesevelam. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking colesevelam:

Less common:
  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • coma
  • confusion
  • congestion
  • cool, pale skin
  • cough
  • depression
  • diarrhea
  • dizziness
  • dry or sore throat
  • fast heartbeat
  • fever
  • general feeling of discomfort or illness
  • headache
  • hoarseness
  • increased hunger
  • joint pain
  • loss of appetite
  • muscle aches or pain
  • nausea
  • nervousness
  • nightmares
  • pounding in the ears
  • runny nose
  • seizures
  • shakiness
  • shivering
  • slow or fast heartbeat
  • slurred speech
  • sweating
  • tender, swollen glands in the neck
  • trouble with sleeping
  • trouble with swallowing
  • unusual tiredness or weakness
  • voice changes
  • vomiting
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

Minor Side Effects

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

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

Not all side effects for colesevelam may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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