Drug Safety Information for NATEGLINIDE (Nateglinide)

Safety-related Labeling Changes for STARLIX (NATEGLINIDE) Rx Drug: FDA Link

Adverse Drug Reactions for NATEGLINIDE* (Nateglinide)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with NATEGLINIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Blood glucose increased421
3Weight decreased235
4Decreased appetite189
10Blood glucose decreased122
11Myocardial infarction121
13Drug ineffective*103
14Cardiac failure congestive101
19Oedema peripheral85

* This side effect also appears in "Top 10 Side Effects of NATEGLINIDE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking NATEGLINIDE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Diabetes mellitus*2284
2Type 2 diabetes mellitus806
3Product used for unknown indication642
4Glucose tolerance impaired537
5Blood glucose increased47
7Blood glucose decreased16
8Cerebral infarction15
10Blood glucose abnormal11

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for NATEGLINIDE

Total Reports Filed with FDA: 14406

Number of FDA Adverse Event Reports by Patient Age for NATEGLINIDE

Total Reports Filed with FDA: 14406*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nateglinide (Fastic, Starlix, Starsis, Nateglinide)

Charts are based on 14406 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and NATEGLINIDE Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on NATEGLINIDE's side effects.