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Repaglinide Side Effects

In Summary

Commonly reported side effects of repaglinide include: hypoglycemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to repaglinide: oral tablet

Along with its needed effects, repaglinide 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 repaglinide:

More Common

Less Common

  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain

Incidence Not Known

  • Back, leg, or stomach pains
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloating
  • clay-colored stools
  • constipation
  • cough
  • darkened urine
  • diarrhea
  • difficulty with breathing
  • fever
  • general body swelling
  • general tiredness and weakness
  • indigestion
  • itching or rash
  • joint or muscle pain
  • light-colored stools
  • loss of appetite
  • nosebleeds
  • pains in the side, or abdomen, possibly radiating to the back
  • pale skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • unpleasant breath odor
  • upper right abdominal or stomach pain
  • vomiting
  • vomiting of blood
  • yellow eyes or skin

Some side effects of repaglinide 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

  • Body aches or pain
  • difficulty with moving
  • ear congestion
  • loss of voice
  • muscle stiffness
  • pain in the joints
  • pain or tenderness around the eyes and cheekbones
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tightness of the chest

Less Common

  • Acid or sour stomach
  • belching
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • cough producing mucus
  • heartburn
  • indigestion
  • weight gain

Incidence Not Known

For Healthcare Professionals

Applies to repaglinide: oral tablet

General

The most frequently reported adverse reactions were changes in blood glucose levels; the occurrence of these reactions was dependent on individual factors such as dietary habits, dose, exercise, and stress.[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (up to 31%)[Ref]

In 12 to 24 week clinical trials, hypoglycemia occurred in 31% of patients receiving this drug compared to 7% of placebo-treated patients. In 1 year trials, hypoglycemia occurred in 16% of patients receiving this drug compared to 19% and 20% of glipizide and glyburide patients, respectively.[Ref]

Cardiovascular

Cardiovascular events were evaluated in trials comparing this drug to sulfonylureas. Serious cardiovascular events including ischemia with this drug were higher at 4% than for sulfonylurea drugs (3%). No excess mortality was associated with this increase. Selected cardiovascular events including hypertension, abnormal EKG, MI, arrhythmias, and palpitations were observed at 1% or less and no more frequently with this drug than with comparator drugs.

Trials of this drug in combination with NPH insulin found 6 serious events of myocardial ischemia.[Ref]

Common (1% to 10%): Chest pain, angina, serious cardiovascular events including ischemia

Frequency not reported: Hypertension, abnormal EKG, MI, arrhythmias, palpitations[Ref]

Hypersensitivity

Common (1% to 10%): Allergy

Uncommon (0.1% to 1%): Allergic skin reactions such as rash, urticaria, and pruritus

Frequency not reported: Anaphylactoid reactions[Ref]

Anaphylactoid reactions were reported in less than 1% of patients. Allergic skin reactions such as rash, urticaria, and pruritus have been observed. There is no reason to suspect cross-allergenicity with sulfonylurea drugs due to the difference in chemical structure.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, constipation, vomiting, dyspepsia, tooth disorder

Postmarketing reports: Pancreatitis[Ref]

Nervous system

Very common (10% or more): Headache (up to 11%)

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

Musculoskeletal

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

Respiratory

Very common (10% or more): Upper respiratory infection (up to 16%)

Common (1% to 10%): Sinusitis, rhinitis, bronchitis[Ref]

Hepatic

Postmarketing experience has included reports of severe hepatic dysfunction including jaundice and hepatitis.[Ref]

Frequency not reported: Elevated liver enzymes

Postmarketing reports: Severe hepatic dysfunction including jaundice and hepatitis[Ref]

Hematologic

Thrombocytopenia or leukopenia have been reported in less than 1% of patients.[Ref]

Frequency not reported: Thrombocytopenia, leukopenia

Postmarketing reports: Hemolytic anemia[Ref]

Ocular

Rare (less than 0.1%): Blurred vision

Very rare (less than 0.01%): Refraction disorder[Ref]

Refraction disorders have been known to result due to changes in blood glucose levels.[Ref]

Dermatologic

Postmarketing reports: Alopecia, Stevens-Johnson syndrome[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

References

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

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Prandin (repaglinide)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

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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