Medical Editor: John P. Cunha, DO, FACOEP
What Is Nateglinide?
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 Nateglinide if needed. Nateglinide is available in generic form.
What Are Side Effects of Nateglinide?
Nateglinide may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- seizure, and
- yellowing of the skin or eyes
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Nateglinide include:
- upper respiratory tract infection,
- back pain,
- flu symptoms,
- dizziness,
- joint pain or inflammation,
- diarrhea,
- bronchitis,
- coughing,
- weight gain, and
- symptoms of low blood sugar (sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue, and weakness).
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Nateglinide
The recommended starting and maintenance dose of Nateglinide, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals.
What Drugs, Substances, or Supplements Interact with Nateglinide?
Nateglinide 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.
Nateglinide During Pregnancy or Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Nateglinide. Nateglinide 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 Nateglinide passes into breast milk. Breastfeeding while using Nateglinide is not recommended.
Additional Information
Our Nateglinide (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.
QUESTION
______________ is another term for type 2 diabetes. See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- seizure (convulsions); or
- jaundice (yellowing of the skin or eyes).
Common side effects may include:
- runny or stuffy nose, sneezing, cough, cold or flu symptoms;
- diarrhea;
- back pain;
- dizziness; or
- joint pain or stiffness.
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.
SLIDESHOW
Type 2 Diabetes: Signs, Symptoms, Treatments See SlideshowSIDE EFFECTS
The following serious adverse reaction is also described elsewhere in the labeling:
- Hypoglycemia [see WARNINGS AND PRECAUTIONS]
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 | STARLIX | |
| N=458 | N=1441 | |
| Preferred Term | ||
| 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
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].
Weight Gain
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.
Laboratory Test
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.
Postmarketing Experience
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
DRUG INTERACTIONS
Table 2 includes a list of drugs with clinically important drug interactions when concomitantly administered or withdrawn with STARLIX and instructions for managing or preventing them.
Table 2: Clinically Significant Drug Interactions with STARLIX
| Drugs That May Increase the Blood-Glucose-Lowering Effect of STARLIX and Susceptibility to Hypoglycemia | |
| Drugs: | Nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, monoamine oxidase inhibitors, non-selective beta-adrenergic-blocking agents, anabolic hormones (e.g., methandrostenolone), guanethidine, gymnema sylvestre, glucomannan, thioctic acid, and inhibitors of CYP2C9 (e.g., amiodarone, fluconazole, voriconazole, sulfinpyrazone) or in patients known to be poor metabolizers of CYP2C9 substrates, alcohol. |
| Intervention: | Dose reductions and increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs. |
| Drugs and Herbals That May Reduce the Blood-Glucose-Lowering Effect of STARLIX and Increase Susceptibility to Hyperglycemia | |
| Drugs: | Thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, somatostatin analogues (e.g., lanreotide, octreotide), and CYP inducers (e.g., rifampin, phenytoin and St John’s Wort). |
| Intervention: | Dose increases and increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs. |
| Drugs That May Blunt Signs and Symptoms of Hypoglycemia | |
| Drugs: | beta-blockers, clonidine, guanethidine, and reserpine |
| Intervention: | Increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs. |
Read the entire FDA prescribing information for Nateglinide (Nateglinide)
© Nateglinide Patient Information is supplied by Cerner Multum, Inc. and Nateglinide Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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