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Nateglinide Safety Reports submitted to FDA

Total Nateglinide reports: 26.
Nateglinide FDA safety alerts: No.
Reported deaths: 3    Reported hospitalizations: 23.
Take Nateglinide Side Effects Survey or Share Your Nateglinide Story.
Reported Nateglinide Side Effects: dizziness, loss of consciousness, disease progression, chest pain, abdominal pain upper, diarrhoea, decreased appetite, body mass index decreased, blood albumin decreased, altered state of consciousness, weight decreased.
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Nateglinide Side Effects Report #5196619-3
Physician from AUSTRALIA reported NATEGLINIDE problem on Dec 22, 2006. Female patient, 74 years of age, was diagnosed with glucose tolerance impaired, cardiovascular disorder and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: headache, pleurisy, pneumonia. NATEGLINIDE dosage: unknown. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5241184-5
NATEGLINIDE problem was reported by a Physician from UNITED KINGDOM on Feb 08, 2007. Male patient, 59 years of age, weighting 137.8 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder, hypertension, hypercholesterolaemia and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: convulsion, fall, hypoglycaemia. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN, ADIZEM, SIMVASTATIN. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5305316-2
Physician from JAPAN reported NATEGLINIDE problem on Apr 12, 2007. Male patient, 74 years of age, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, gastric cancer, gastric operation, gastric ulcer, gastrooesophageal reflux disease. NATEGLINIDE dosage: 180 MG/DAY. During the same period patient was treated with ACTOS, TAKEPRON, KINEDAK, AMARYL. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5306855-0
NATEGLINIDE problem was reported by a Physician from JAPAN on Apr 24, 2007. Male patient, 74 years of age, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, gastric cancer, gastric operation, gastric ulcer, gastrooesophageal reflux disease. NATEGLINIDE dosage: 180 MG/DAY. During the same period patient was treated with ACTOS, TAKEPRON, KINEDAK, AMARYL. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5317624-X
Physician from CHILE reported NATEGLINIDE problem on Apr 26, 2007. Male patient, 69 years of age, weighting 191.8 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: angina unstable, arterial injury, arterial occlusive disease, cardiac enzymes increased, chest pain, disease progression, myocardial infarction. NATEGLINIDE dosage: unknown. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5327042-6
NATEGLINIDE problem was reported by a Physician from UNITED STATES on May 07, 2007. Male patient, 77 years of age, weighting 144.0 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, abdominal distension, abdominal tenderness, benign colonic neoplasm, bradycardia, cardiac pacemaker insertion, colectomy, disease progression, inflammation. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5327767-2
Physician from RUSSIAN FEDERATION reported NATEGLINIDE problem on May 10, 2007. Female patient, 59 years of age, weighting 217.6 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: angina pectoris, autoimmune thyroiditis, blood cholesterol increased, cardiac failure, chest pain, coronary artery disease, dyspnoea, hepatic steatosis, high density lipoprotein decreased. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5332447-3
NATEGLINIDE problem was reported by a Physician from RUSSIAN FEDERATION on May 17, 2007. Female patient, 59 years of age, weighting 217.6 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: angina pectoris, autoimmune thyroiditis, blood cholesterol increased, cardiac failure, chest pain, coronary artery disease, dyspnoea, hepatic steatosis, high density lipoprotein decreased. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5341476-5
Physician from UNITED STATES reported NATEGLINIDE problem on May 24, 2007. Female patient, 74 years of age, weighting 244.5 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder, hypertension and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: loss of consciousness. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN, ATENOLOL. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5356939-6
NATEGLINIDE problem was reported by a Physician from CHILE on June 07, 2007. Male patient, 69 years of age, weighting 191.8 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: angina unstable, arterial injury, arterial occlusive disease, cardiac enzymes increased, chest pain, disease progression, glucose tolerance impaired, myocardial infarction, vascular bypass graft. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5360122-8
Physician from JAPAN reported NATEGLINIDE problem on June 15, 2007. Male patient, 65 years of age, was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: pancreatic carcinoma. NATEGLINIDE dosage: unknown. Patient died on 03/02/2006.

Nateglinide Side Effects Report #5368192-8
NATEGLINIDE problem was reported by a Physician from UNITED STATES on June 14, 2007. Female patient, 74 years of age, weighting 244.5 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder, hypertension and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: dizziness, loss of consciousness, weight decreased. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN, ATENOLOL. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5369995-6
Physician from JAPAN reported NATEGLINIDE problem on June 15, 2007. Female patient, 69 years of age, was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: lung neoplasm malignant. NATEGLINIDE dosage: unknown. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5374327-3
NATEGLINIDE problem was reported by a Physician from JAPAN on June 26, 2007. Male patient, 65 years of age, was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, ascites, aspartate aminotransferase increased, bile duct stent insertion, bile duct t-tube insertion, biliary dilatation, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased. NATEGLINIDE dosage: unknown. During the same period patient was treated with METFORMINE. Patient was hospitalized. Patient died on 03/02/2006.

Nateglinide Side Effects Report #5095087-X
Consumer or non-health professional from UNITED KINGDOM reported NATEGLINIDE problem on Aug 24, 2006. Female patient, 66 years of age, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: dizziness, dyspnoea, fluid retention, food craving, nausea, weight increased. NATEGLINIDE dosage: 60 MG, TID. During the same period patient was treated with AQUEOUS CREAM, ASPIRIN, EMULSIDERM, FLUARIX, LORATADINE, METFORMIN HYDROCHLORIDE, PNEUMOVAX, RAMIPRIL. Patient recovered.

Nateglinide Side Effects Report #5381742-0
NATEGLINIDE problem was reported by a Physician from JAPAN on July 05, 2007. Male patient, 65 years of age, was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, ascites, aspartate aminotransferase increased, bile duct stent insertion, bile duct t-tube insertion, biliary dilatation, blood alkaline phosphatase increased, blood bilirubin increased, blood chloride decreased. NATEGLINIDE dosage: unknown. During the same period patient was treated with METFORMINE. Patient was hospitalized. Patient died on 03/02/2006.

Nateglinide Side Effects Report #5411757-5
Health Professional from JAPAN reported NATEGLINIDE problem on Aug 03, 2007. Male patient, 61 years of age, was diagnosed with diabetes mellitus and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, blood albumin decreased, blood pressure decreased, body mass index decreased, body temperature decreased, decreased appetite, diarrhoea, electrocardiogram abnormal, glycosylated haemoglobin increased. NATEGLINIDE dosage: 270 MG, UNK. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5417750-0
NATEGLINIDE problem was reported by a Physician from UNITED STATES on Aug 09, 2007. Female patient, 74 years of age, weighting 244.5 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder, hypertension and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: dizziness, loss of consciousness, weight decreased. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN, ATENOLOL. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5417782-2
Physician from UNITED STATES reported NATEGLINIDE problem on Aug 09, 2007. Female patient, 74 years of age, weighting 244.5 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder, hypertension and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: dizziness, loss of consciousness, weight decreased. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN, ATENOLOL. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5419071-9
NATEGLINIDE problem was reported by a Health Professional from JAPAN on Aug 10, 2007. Male patient, 61 years of age, was diagnosed with diabetes mellitus and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, blood albumin decreased, blood pressure decreased, body mass index decreased, body temperature decreased, decreased appetite, diarrhoea, electrocardiogram abnormal, glycosylated haemoglobin increased. NATEGLINIDE dosage: 270 MG, UNK. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5432981-1
Physician from UNITED STATES reported NATEGLINIDE problem on Aug 22, 2007. Male patient, 74 years of age, weighting 227.1 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder, hypertension and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: cervical vertebral fracture, contusion, fall, hypotension, loss of consciousness, skin laceration, syncope. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN, FELODIPINE. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5442613-4
NATEGLINIDE problem was reported by a Pharmacist from JAPAN on Aug 16, 2007. Female patient was diagnosed with diabetes mellitus and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: dizziness, pancreatitis. NATEGLINIDE dosage: 270 MG, UNK. During the same period patient was treated with MICARDIS, BASEN. Patient recovered.

Nateglinide Side Effects Report #5445885-5
Health Professional from JAPAN reported NATEGLINIDE problem on Aug 30, 2007. Male patient, 61 years of age, was diagnosed with diabetes mellitus and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, bladder irrigation, blood albumin decreased, blood creatinine decreased, blood potassium decreased, blood sodium decreased, body mass index decreased, decreased appetite, diarrhoea. NATEGLINIDE dosage: 270 MG QD. During the same period patient was treated with GLUCOBAY, MELBIN, FAMOTIDINE, ALDACTONE, LASIX, METHYCOBAL. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5450857-0
NATEGLINIDE problem was reported by a Physician from UNITED KINGDOM on Sept 04, 2007. Male patient, 68 years of age, weighting 196.2 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, nephrolithiasis, ureteral stent insertion. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5453666-1
Physician from UNITED KINGDOM reported NATEGLINIDE problem on Sept 11, 2007. Male patient, 68 years of age, weighting 196.2 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, nephrolithiasis, renal colic, ureteral stent insertion. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN. Patient was hospitalized. Patient recovered.

Nateglinide Side Effects Report #5470575-2
NATEGLINIDE problem was reported by a Physician from UNITED STATES on Sept 18, 2007. Male patient, 67 years of age, weighting 267.6 lb, was diagnosed with glucose tolerance impaired, cardiovascular disorder, hypertension and was treated with NATEGLINIDE. After drug was administered, patient experienced the following problems/side effects: arrhythmia, disease progression, dizziness, extrasystoles, implantable defibrillator insertion, palpitations, presyncope, sinus bradycardia, ventricular extrasystoles. NATEGLINIDE dosage: unknown. During the same period patient was treated with VALSARTAN, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE, LASIX. Patient was hospitalized. Patient recovered.


Drug Information: Nateglinide Oral

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a699057.html

(nuh tay' gli nide)

Why is this medication prescribed?

Nateglinide is used alone or in combination with other medications to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) in people whose diabetes cannot be controlled by diet and exercise alone. Nateglinide belongs to a class of drugs called meglitinides. Nateglinide helps your body regulate the amount of glucose (sugar) in your blood. It decreases the amount of glucose by stimulating the pancreas to release insulin.

How should this medicine be used?

Nateglinide comes as a tablet to take by mouth. It is usually taken three times daily. Take nateglinide any time from 30 minutes before a meal to just before the meal. If you skip a meal, you need to skip the dose of nateglinide. If you add a meal, add a dose of nateglinide. Your doctor may gradually increase your dose, depending on your response to nateglinide. Monitor your blood glucose closely. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nateglinide exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor.

Nateglinide controls diabetes but does not cure it. Continue to take nateglinide even if you feel well. Do not stop taking nateglinide without talking with your doctor.

Other uses for this medicine

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking nateglinide,

  • tell your doctor and pharmacist if you are allergic to nateglinide or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially albuterol (Proventil, Ventolin); allergy or cold medications; aspirin and nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn); beta-blockers such as propranolol (Inderal); chloramphenicol (Chloromycetin); chlorpromazine (Thorazine); corticosteroids such as dexamethasone (Decadron), methylprednisolone (Medrol), or prednisone (Deltasone, Orasone); diuretics ('water pills'); epinephrine; estrogens; fluphenazine (Prolixin); isoniazid (Rifamate); medications that contain alcohol or sugar; mesoridazine (Serentil); niacin; oral contraceptives (birth control pills); perphenazine (Trilafon); phenelzine (Nardil); probenecid (Benemid); prochlorperazine (Compazine); promazine (Sparine); promethazine (Phenergan); terbutaline (Brethine, Bricanyl); thioridazine (Mellaril); thyroid medication; tranylcypromine (Parnate); trifluoperazine (Stelazine); triflupromazine (Vesprin); trimeprazine (Temaril); and vitamins or herbal products.
  • tell your doctor if you have or have ever had liver or pituitary disease, adrenal insufficiency, diabetic ketoacidosis, neuropathy (disease of the nervous system), or if you have been told you have type 1 diabetes mellitus (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) .
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking nateglinide, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nateglinide.
  • tell your doctor if you have fever, infection, injury, or illness with vomiting or diarrhea. These may affect your blood sugar level.

What special dietary instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. Calorie reduction, weight loss, and exercise will help control your diabetes and will also make nateglinide work better. It is important to eat a healthful diet. Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking nateglinide..

What should I do if I forget a dose?

Before you start taking nateglinide, ask your doctor what to do if you forget to take a dose. Write these directions down so you can refer to them later. As a general rule, if you have just begun to eat a meal, take the missed dose as soon as you remember it. However, if you have finished eating, or if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:

  • shakiness
  • dizziness or lightheadedness
  • sweating
  • nervousness or irritability
  • sudden changes in behavior or mood
  • headache
  • numbness or tingling around the mouth
  • weakness
  • pale skin
  • hunger
  • clumsy or jerky movements

If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.

  • confusion
  • seizures
  • loss of consciousness

Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):

  • extreme thirst
  • frequent urination
  • extreme hunger
  • weakness
  • blurred vision

If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of the these symptoms:

  • dry mouth
  • upset stomach and vomiting
  • shortness of breath
  • breath that smells fruity
  • decreased consciousness

Nateglinide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • nasal congestion
  • runny nose
  • joint aches
  • back pain
  • constipation
  • cough
  • flu-like symptoms

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to nateglinide. Your doctor will also tell you how to check your response to this medication by measuring your blood or urine sugar levels at home. Follow these instructions carefully.

Keep yourself and your clothes clean. Wash cuts, scrapes, and other wounds quickly, and do not let them get infected.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

  • Starlix®

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headache, pleurisy, pneumonia convulsion, fall, hypoglycaemia abdominal pain upper, gastric cancer, gastric operation, gastric ulcer, gastrooesophageal reflux disease, was diagnosed with glucose tolerance impaired, cardiovascular disorder and was diagnosed with glucose tolerance impaired, cardiovascular disorder, hypertension, hypercholesterolaemia and