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Starlix (Nateglinide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Starlix (Nateglinide) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (13)
Death (1)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Drug Ineffective (4)Blood Glucose Abnormal (3)Urinary Tract Infection (3)Hypoglycaemic Coma (2)Blood Glucose Increased (2)Renal Failure Acute (2)Localised Infection (2)Metabolic Acidosis (2)Haematuria (2)Renal Injury (1)Hypersensitivity (1)Blood Triglycerides Increased (1)

Possible Starlix side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Zelmac
    Dosage: unk ukn, unk

Starlix
    Dosage: unk ukn, unk



Possible Starlix side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-07-30

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Product Blister Packaging Issue, Road Traffic Accident, Drug Ineffective, Product Colour Issue, Blood Glucose Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Starlix

Other drugs received by patient: Metformin Hydrochloride; Acarbose; Glimepiride



Possible Starlix side effects in female

Reported by a physician from Taiwan, Province of China on 2012-06-07

Patient: female

Reactions: Drug Ineffective, Urinary Tract Infection, Blood Glucose Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Starlix



Possible Starlix side effects in female

Reported by a physician from Taiwan, Province of China on 2012-06-06

Patient: female

Reactions: Drug Ineffective, Urinary Tract Infection, Blood Glucose Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Starlix



Possible Starlix side effects in female

Reported by a physician from Taiwan, Province of China on 2012-06-04

Patient: female

Reactions: Drug Ineffective, Urinary Tract Infection, Blood Glucose Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Starlix



Possible Starlix side effects in female

Reported by a physician from United States on 2012-05-23

Patient: female, weighing 94.3 kg (207.6 pounds)

Reactions: Hypersensitivity, Rash

Drug(s) suspected as cause:
Starlix



Possible Starlix side effects in 47 year old male

Reported by a consumer/non-health professional from Brazil on 2012-04-27

Patient: 47 year old male

Reactions: Localised Infection

Drug(s) suspected as cause:
Starlix



Possible Starlix side effects in 47 year old male

Reported by a consumer/non-health professional from Brazil on 2012-03-28

Patient: 47 year old male

Reactions: Localised Infection

Drug(s) suspected as cause:
Starlix



Possible Starlix side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-03-08

Patient: 74 year old male

Reactions: Metabolic Acidosis, Haematuria, Hypoglycaemic Coma, Renal Failure Acute

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Irbesartan and Hydrochlorothiazide
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 2011-12-01

Amoxicillin + Clavulanate Potassium
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2011-12-31

Voltaren
    Dosage: coated tablets, dragees
    Administration route: Oral
    Indication: Arthralgia
    Start date: 2011-12-31

Diamicron
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Starlix
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Other drugs received by patient: Metformin Hydrochloride; Tramadol HCL



Possible Starlix side effects 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

Drug(s) suspected as cause:
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



Possible Starlix side effects 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

Drug(s) suspected as cause:
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 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

Drug(s) suspected as cause:
Starlix



Possible Starlix side effects in female

Reported by a physician from United States on 2011-10-03

Patient: female, weighing 89.8 kg (197.6 pounds)

Reactions: Renal Injury, Oedema Peripheral, Blood Glucose Increased, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Starlix

Other drugs received by patient: Actos; Glimepiride; Januvia; Metformin HCL

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