Drug Safety Information for ACTOPLUS MET (Metformin hydrochloride; pioglitazone hydrochloride)

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

Adverse Drug Reactions for ACTOPLUS MET* (Metformin hydrochloride; pioglitazone 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 ACTOPLUS MET
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Bladder cancer116
2Blood glucose increased106
3Nausea91
4Weight decreased74
5Flushing54
6Dizziness43
7Blood glucose decreased42
8Vomiting39
9Asthenia37
10Decreased appetite36
11Dyspnoea36
12Fatigue36
13Diarrhoea32
14Drug ineffective31
15Weight increased31
16Oedema peripheral29
17Headache28
18Pruritus25
19Arthralgia23
20Chest pain22

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

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

Reason # of FDA Reports
1Type 2 diabetes mellitus941
2Diabetes mellitus454
3Product used for unknown indication315
4Insulin-requiring type 2 diabetes mellitus21
5Diabetes mellitus management19
6Glucose tolerance impaired10
7Diabetes mellitus inadequate control9
8Blood glucose increased7
9Type 1 diabetes mellitus6
10Osteoporosis3

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


Types of Adverse Events for ACTOPLUS MET

Total Reports Filed with FDA: 3807


Number of FDA Adverse Event Reports by Patient Age for ACTOPLUS MET

Total Reports Filed with FDA: 3807*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Metformin hydrochloride; pioglitazone hydrochloride (Actoplus met xr, Actoplus met)

Charts are based on 3807 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 ACTOPLUS MET 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 ACTOPLUS MET's side effects.