Brand name · Pioglitazone and metformin hydrochloride
Actoplus Met: adverse event reports filed with FDA
558 reports list it as a suspect or interacting product, 2006–2023. Class: Biguanide. Also reported as Actoplus Met Xr.
- 558
- reports as suspect product
- 0% of all reports · about 27 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 89.1%
- marked serious by the reporter
- 81.3% across the class
- 14.3%
- record death among outcomes, as reported
- 80 reports · not verified by FDA
Between March 2006 and June 2023, 558 adverse event reports received by FDA list the brand name Actoplus Met (pioglitazone and metformin hydrochloride) as a suspect or interacting product. Reports that mention it only as a concomitant medication (745) are left out of every figure here.
In the 12 months to June 2026, 0 reports listed it, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 27 reports a year and 0% of the 20,646,523 reports in the database, and 0.5% of the reports for the biguanide class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are bladder cancer (53.9%), death (7.9%) and bladder transitional cell carcinoma (3.4%). A report can list several reactions, so shares add to more than 100%; 129 different terms appear across these reports. Bladder cancer is recorded in 53.9% of these reports, a larger share than in the median biguanide drug (0.1%).
89.1% of the reports are marked serious by the reporter (81.3% across the class); 14.3% record death among the outcomes and 13.6% record hospitalisation, as reported. 34.4% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (22.8%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
Reactions recorded in the reports
share of Actoplus Met reports recording the termmedian drug in biguanide
- Bladder cancer53.9%301
- Deaththe patient died; cause not stated by this term7.9%44
- Bladder transitional cell carcinoma3.4%19
- Blood glucose increasedraised blood sugar reading2.9%16
- Weight increasedweight gain2.9%16
- Weight decreasedweight loss2.3%13
- Cardiac failure congestivecongestive heart failure2.2%12
- Pneumonialung infection2.2%12
- Atrial fibrillationan irregular heart rhythm2%11
- Dyspnoeashortness of breath2%11
- Bladder cancer recurrent1.8%10
- Oedema peripheralswelling of the legs, ankles or hands1.8%10
- Dizzinesslight-headedness or unsteadiness1.4%8
- Haematuriablood in the urine1.4%8
- Astheniaweakness or lack of energy1.3%7
- Blood glucose decreasedlow blood sugar reading1.3%7
- Incorrect dose administeredthe wrong dose was given1.3%7
- Peripheral swellingswelling of the arms or legs1.3%7
- Urinary tract infectionbladder or urinary infection1.3%7
- Nauseafeeling sick1.1%6
- Renal failure acute1.1%6
- Angioedemadeep swelling of skin or mucous membranes0.9%5
- Myocardial infarctionheart attack0.9%5
- Drug dispensing errora dispensing mistake0.7%4
- Lactic acidosisa build-up of lactic acid in the blood0.7%4
- Prostate cancer0.7%4
- Abdominal distensiona bloated abdomen0.5%3
- Abdominal painstomach or belly pain0.5%3
- Abdominal pain upperupper stomach pain0.5%3
Top 30 of 129 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the biguanide class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 116,598 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 92.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Type 2 diabetes mellitus | 361 | 64.7% |
| Diabetes mellitus | 42 | 7.5% |
| Diabetes mellitus non-insulin-dependent | 13 | 2.3% |
| Blood glucose increased | 2 | 0.4% |
| Type 1 diabetes mellitus | 2 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 558 reports.
In context
| Measure | Actoplus Met | Biguanide | All reports |
|---|---|---|---|
| Reports as suspect product | 558 | 116,598 | 20,646,523 |
| Share of that pool | — | 0.5% | 0% |
| Reports, latest 12 months | 0 | — | 1,332,454 |
| Marked serious | 89.1% | 81.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 143 | 139 | 91 |
| Hospitalisation recorded, per 1,000 reports | 136 | 431 | 213 |
| Consumer-filed share | 19.4% | 28.4% | 45.8% |
| Top term, share of reports | Bladder cancer 53.9% | median 0.1% | 0.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the biguanide class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Metformin | generic | 66,495 | 5,178 | 87.1% |
| Metformin hydrochloride | generic | 24,187 | 1,851 | 80.6% |
| Metformin hcl | generic | 11,314 | 0 | 67.2% |
| Janumet | brand | 10,509 | 133 | 64.9% |
| Xigduo | brand | 2,199 | 177 | 76.5% |
| Invokamet | brand | 1,336 | 1 | 60% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Actoplus Met reports
How many adverse event reports has FDA received for Actoplus Met?
558 reports list Actoplus Met as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 745 list it only as a concomitant medication.
What reactions are recorded in Actoplus Met reports?
bladder cancer (53.9%), death (7.9%), bladder transitional cell carcinoma (3.4%), blood glucose increased (2.9%) and weight increased (2.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Actoplus Met was responsible.
How serious are the reports?
89.1% are marked serious by the reporter. Among the outcomes recorded, 14.3% of reports include death and 13.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
lawyer (34.4%), consumer or non-health professional (19.4%) and physician (17.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Actoplus Met rising?
0 reports in the 12 months to June 2026, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Actoplus Met was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Actoplus Met?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Actoplus Met as a suspect or interacting product; reports listing it only as a concomitant medication (745) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.