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Starlix (Nateglinide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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. 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 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.

Common Adverse Events (≥ 2% in Starlix® patients) in Starlix® Monotherapy Trials (% of patients)
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 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 A cid: 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.



REPORTS OF SUSPECTED STARLIX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Starlix. The information is not vetted and should not be considered as verified clinical evidence.

Possible Starlix side effects / adverse reactions in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-01

Patient: 65 year old male

Reactions: Emotional Distress, Dyspnoea

Suspect drug(s):
Starlix



Possible Starlix side effects / adverse reactions in 66 year old female

Reported by a physician from Brazil on 2011-11-23

Patient: 66 year old female weighing 61.5 kg (135.3 pounds)

Reactions: Glycosylated Haemoglobin Increased, Thyroid Cancer, Blood Triglycerides Increased, Uveitis

Suspect drug(s):
Starlix

Other drugs received by patient: Amaryl; Methotrexate; Insulin Glargine; Fosamax; Glimepiride; Meticorten; Osteocalcin; Cibrato; Metformin; Prednisone TAB; Oroxadin; Lipitor; Protos



Possible Starlix side effects / adverse reactions in 74 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-03-06

Patient: 74 year old male

Reactions: Malaise, Metabolic Acidosis, Haematuria, Hypoglycaemic Coma, Decreased Appetite, Loss of Consciousness, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Diamicron
    Dosage: 60 mg, daily
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Starlix
    Dosage: 60 mg, daily
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Amoxicillin and Clavulanate Potassium
    Dosage: 1250 mg, unk
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2011-12-31

Voltaren
    Dosage: 1 df, once/single
    Administration route: Oral
    Indication: Arthralgia
    Start date: 2011-12-31

Irbesartan + Hydrochlorothiazide
    Dosage: 150 mg, daily (concentration: 150/12.5)
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 2011-12-01

Other drugs received by patient: Tramadol Hydrochloride; Metformin HCL



See index of all Starlix side effect reports >>

Drug label data at the top of this Page last updated: 2013-01-31

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