Applies to nateglinide: oral tablet.

Serious side effects of Nateglinide

Along with its needed effects, nateglinide 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 nateglinide:

More common

• Ear congestion
• cough
• difficulty in breathing
• loss of voice
• sneezing
• sore throat
• stuffy or runny nose

Less common

• Chest tightness
• cough producing mucus
• diarrhea
• general discomfort or illness
• shivering
• sweating
• trouble sleeping
• vomiting

Incidence not known

• Anxiety
• blurred vision
• chills
• clay-colored stools
• cold sweats
• coma
• confusion
• cool, pale skin
• dark urine
• depression
• dizziness
• fast heartbeat
• fever
• headache
• increased hunger
• loss of appetite
• nausea
• nervousness
• nightmares
• seizures
• shakiness
• slurred speech
• stomach pain
• unusual tiredness or weakness
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Other side effects of Nateglinide

Some side effects of nateglinide 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:

Less common

• Back pain
• dizziness
• joint pain
• muscle aches and pains

incidence not known

• Hives, itching, skin rash
• redness of the skin

For Healthcare Professionals

Applies to nateglinide: oral tablet.

General

The most frequently reported adverse events included upper respiratory tract infections and symptoms of hypoglycemia.^[Ref]

Metabolic

Common (1% to 10%): Hypoglycemia

Frequency not reported: Increases in mean uric acid level^[Ref]

Hypoglycemia has been reported and has generally been mild and corrected by intake of carbohydrates. In comparative clinical trials, hypoglycemia was reported in 10.4%, 14.5%, 6.9%, 19.8%, and 4.1% in patients receiving nateglinide alone, nateglinide plus metformin, metformin alone, glyburide alone, and placebo, respectively.

Mean uric acid levels were increased in patient receiving this drug as monotherapy. The difference from placebo in treated patients was 0.29 mg/dL, 0.45 mg/dL, 0.28 mg/dL, and 0.19 mg/dL in patients receiving nateglinide alone, nateglinide plus metformin, metformin alone, glyburide alone, respectively. The clinical significance of these findings is unknown.^[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, bronchitis, coughing^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions such as rash, itching, and urticaria^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, nausea

Uncommon (0.1% to 1%): Vomiting^[Ref]

Gastrointestinal symptoms, especially diarrhea and nausea, were no more common in patients using this drug in combination with metformin than in patients receiving metformin alone.^[Ref]

Hepatic

Postmarketing reports: Elevated liver enzymes, jaundice, cholestatic hepatitis^[Ref]

Nervous system

Common (1% to 10%): Dizziness^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthropathy^[Ref]

Cardiovascular

Frequency not reported: Peripheral edema^[Ref]

Peripheral edema was no more common in patients using this drug in combination with rosiglitazone than in patients receiving rosiglitazone alone.^[Ref]

Dermatologic

Postmarketing reports: Erythema multiforme^[Ref]

Immunologic

Common (1% to 10%): Flu symptoms^[Ref]

Other

Common (1% to 10%): Accidental trauma^[Ref]