Nateglinide Side Effects
Brand Names: Starlix
Please note - some side effects for Nateglinide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Nateglinide - for the Consumer
Nateglinide
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 Nateglinide:
Seek medical attention right away if any of these SEVERE side effects occur when using Nateglinide:Dizziness; flu-like symptoms (fever, chills, sore throat); joint pain; upper respiratory tract infection.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, unusual nausea or tiredness, yellowing of the skin or eyes); symptoms of low blood sugar (eg, anxiety, chills, fast heartbeat, headache, increased hunger, severe or persistent dizziness or drowsiness, tremors, unusual sweating, vision changes, weakness).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopNateglinide Side Effects - for the Professional
Nateglinide
In clinical trials, approximately 2,600 patients with Type 2 diabetes were treated with 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 Nateglinide patients discontinued due to hypoglycemia. Symptoms suggestive of hypoglycemia have been observed after administration of Nateglinide. These symptoms included sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue and weakness.
Gastrointestinal symptoms, especially diarrhea and nausea, were no more common in patients using the combination of Nateglinide and metformin than in patients receiving metformin alone. Likewise, peripheral edema was no more common in patients using the combination of Nateglinide and rosiglitazone than in patients receiving rosiglitazone alone. The following table lists events that occurred more frequently in Nateglinide patients than placebo patients in controlled clinical trials.
| Preferred Term | PlaceboN=458 | NateglinideN=1441 |
| Upper Respiratory Infection | 8.1 | 10.5 |
| Back Pain | 3.7 | 4.0 |
| Flu Symptoms | 2.6 | 3.6 |
| Dizziness | 2.2 | 3.6 |
| Arthropathy | 2.2 | 3.3 |
| Diarrhea | 3.1 | 3.2 |
| Accidental Trauma | 1.7 | 2.9 |
| Bronchitis | 2.6 | 2.7 |
| Coughing | 2.2 | 2.4 |
| Hypoglycemia | 0.4 | 2.4 |
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 Nateglinide alone, Nateglinide 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.
TopSide Effects by Body System - for Healthcare Professionals
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.
TopMore Nateglinide resources
- Nateglinide Prescribing Information (FDA)
- Nateglinide Professional Patient Advice (Wolters Kluwer)
- Nateglinide Monograph (AHFS DI)
- Nateglinide MedFacts Consumer Leaflet (Wolters Kluwer)
- nateglinide Advanced Consumer (Micromedex) - Includes Dosage Information
- Starlix Prescribing Information (FDA)
- Starlix Consumer Overview
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