Medical Editor: John P. Cunha, DO, FACOEP
Starlix (nateglinide) is an oral diabetes medicine used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Other diabetes medicines are sometimes used in combination with Starlix if needed. Starlix is available in generic form. Common side effects of Starlix include:
- upper respiratory tract infection,
- back pain,
- flu symptoms,
- joint pain or inflammation,
- weight gain, and
- symptoms of low blood sugar (sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue, and weakness).
The recommended starting and maintenance dose of Starlix, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals. Starlix may interact with isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, and diet pills, medicines to treat asthma, medicines to treat colds or allergies, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, guanethidine, fluconazole, amiodarone, miconazole, oxandrolone, sympathomimetics, somatropin, rifampin, phenytoin, St John's wort, or probenecid. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Starlix. Starlix is generally not recommended for use during pregnancy. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor to manage blood sugar while pregnant. Your doctor may change diabetes treatment during your pregnancy. It is unknown if Starlix passes into breast milk. Breastfeeding while using Starlix is not recommended.
Our Starlix (nateglinide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reaction is also described elsewhere in the labeling:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, approximately 2,600 patients with type 2 diabetes mellitus were treated with STARLIX. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer. Table 1 shows the most common adverse reactions associated with STARLIX.
Table 1: Adverse Reactions other than Hypoglycemia (%) occurring Greater than or Equal to 2% in STARLIX-Treated Patients from Pool of 12 to 64 week Placebo Controlled Trials
|Upper Respiratory Infection||8.1||10.5|
Episodes of severe hypoglycemia (plasma glucose less than 36 mg/dL) were reported in two patients treated with STARLIX. Non-severe hypoglycemia occurred in 2.4 % of STARLIX treated patients and 0.4 % of placebo treated patients [see WARNINGS AND PRECAUTIONS].
Patients treated with STARLIX had statistically significant mean increases in weight compared to placebo. In clinical trials, the mean weight increases with STARLIX 60 mg (3 times daily) and STARLIX 120 mg (3 times daily) compared to placebo were 1.0 kg and 1.6 kg respectively.
Increases in 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 following adverse reactions have been identified during post-approval use of STARLIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Hypersensitivity reactions: Rash, itching, and urticaria
- Hepatobiliary Disorders: Jaundice, cholestatic hepatitis, and elevated liver enzymes
Read the entire FDA prescribing information for Nateglinide (Nateglinide)