Drug Safety Information for GLUCOPHAGE XR (Metformin hydrochloride)
Safety-related Labeling Changes for GLUCOPHAGE (METFORMIN HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for GLUCOPHAGE XR (METFORMIN HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for AVANDAMET (METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE) Discontinued Drug: FDA Link
Safety-related Labeling Changes for FORTAMET (METFORMIN HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for RIOMET (METFORMIN HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for GLUMETZA (METFORMIN HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for ACTOPLUS MET (METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for ACTOPLUS MET XR (METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE) Discontinued Drug: FDA Link
Safety-related Labeling Changes for JANUMET (METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE) Rx Drug: FDA Link
Safety-related Labeling Changes for PRANDIMET (METFORMIN HYDROCHLORIDE; REPAGLINIDE) Discontinued Drug: FDA Link
Safety-related Labeling Changes for KOMBIGLYZE XR (METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for JANUMET XR (METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE) Rx Drug: FDA Link
Adverse Drug Reactions for GLUCOPHAGE XR* (Metformin hydrochloride)
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 GLUCOPHAGE XR
(reported in FDA Medwatch/FAERS Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Blood glucose increased | 3940 |
| 2 | Nausea* | 3535 |
| 3 | Weight decreased* | 2595 |
| 4 | Diarrhoea* | 2225 |
| 5 | Vomiting | 1923 |
| 6 | Myocardial infarction | 1706 |
| 7 | Decreased appetite* | 1703 |
| 8 | Dizziness | 1510 |
| 9 | Dyspnoea | 1507 |
| 10 | Renal failure acute | 1429 |
| 11 | Drug ineffective | 1424 |
| 12 | Fatigue | 1411 |
| 13 | Headache* | 1271 |
| 14 | Blood glucose decreased | 1258 |
| 15 | Asthenia | 1253 |
| 16 | Pain | 1161 |
| 17 | Cardiac failure congestive | 1134 |
| 18 | Lactic acidosis | 1115 |
| 19 | Chest pain | 1022 |
| 20 | Cerebrovascular accident | 1013 |
* This side effect also appears in "Top 10 Side Effects of GLUCOPHAGE XR " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking GLUCOPHAGE XR
(associated with FDA Medwatch/FAERS Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Diabetes mellitus* | 20252 |
| 2 | Type 2 diabetes mellitus | 13792 |
| 3 | Product used for unknown indication | 8893 |
| 4 | Polycystic ovaries* | 524 |
| 5 | Type 1 diabetes mellitus | 392 |
| 6 | Glucose tolerance impaired* | 289 |
| 7 | Ill-defined disorder | 215 |
| 8 | Blood glucose abnormal | 179 |
| 9 | Insulin resistance* | 174 |
| 10 | Blood glucose increased | 173 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for GLUCOPHAGE XR
Total Reports Filed with FDA: 160889
Number of FDA Adverse Event Reports by Patient Age for GLUCOPHAGE XR
Total Reports Filed with FDA: 160889*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Metformin hydrochloride (Glucophage xr, Riomet, Glumetza, Fortamet, Glucophage)
Charts are based on 160889 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 GLUCOPHAGE XR Reviews and Review Summary .
Historical 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.