Starlix Side Effects

Generic Name: nateglinide

Please note - some side effects for Starlix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Starlix - for the Consumer

Starlix

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Starlix:

Changes in vision; dizziness; flu symptoms (fever, chills, sore throat); headache; increased heartbeat; increased hunger; joint pain; nervousness; sweating; tiredness; tremor; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; stomach pain; yellowing of the skin or eyes.

Starlix Side Effects - for the Professional

Starlix

In clinical trials, approximately 2,600 patients with Type 2 diabetes were treated with Starlix® (nateglinide). Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer.

Hypoglycemia was relatively uncommon in all treatment arms of the clinical trials. Only 0.3% of Starlix patients discontinued due to hypoglycemia. Gastrointestinal symptoms, especially diarrhea and nausea, were no more common in patients using the combination of Starlix and metformin than in patients receiving metformin alone. Likewise, peripheral edema was no more common in patients using the combination of Starlix and rosiglitazone than in patients receiving rosiglitazone alone. The following table lists events that occurred more frequently in Starlix patients than placebo patients in controlled clinical trials.

During post-marketing experience, rare cases of hypersensitivity reactions such as rash, itching and urticaria have been reported. Similarly, cases of jaundice, cholestatic hepatitis and elevated liver enzymes have been reported.

Laboratory Abnormalities

Uric Acid: There were increases in mean uric acid levels for patients treated with Starlix alone, Starlix in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dL, 0.45 mg/dL, 0.28 mg/dL, and 0.19 mg/dL. The clinical significance of these findings is unknown.

Side Effects by Body System

General

Nateglinide is generally well tolerated with the incidence of adverse effects similar to placebo. Upper respiratory tract infections, dizziness, flu symptoms, arthropathy, and accidental trauma were reported slightly more frequently than placebo in clinical trials.

Musculoskeletal

Musculoskeletal side effects have included back pain (4.0%) and arthropathy (3.3%).

Respiratory

Respiratory side effects have included upper respiratory infection (10.5%), bronchitis (2.7%), and coughing (2.4%).

Endocrine

There were increases in mean uric acid levels for patients treated with nateglinide alone, nateglinide in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dL, 0.28 mg/dL, 0.28 mg/dL.

Endocrine side effects have included hypoglycemia (2.4%) and increases in uric acid.

Hypersensitivity

Hypersensitivity side effects have included rare cases of rash, itching and urticaria in postmarketing experience.

Hepatic

Hepatic side effects have included post-marketing reports of jaundice, cholestatic hepatitis, and elevated liver enzymes.

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