METFORMIN\SITAGLIPTIN: 8,810 Adverse Event Reports & Safety Profile
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8,810
Total FAERS Reports
1,110 (12.6%)
Deaths Reported
2,869
Hospitalizations
8,810
As Primary/Secondary Suspect
678
Life-Threatening
242
Disabilities
Active Ingredient: METFORMIN HYDROCHLORIDE\SITAGLIPTIN PHOSPHATE ·
First Report: 1992 · Latest Report: 20250828
What Are the Most Common METFORMIN\SITAGLIPTIN Side Effects?
#1 Most Reported
Blood glucose increased
709 reports (8.0%)
#2 Most Reported
Acute kidney injury
616 reports (7.0%)
#3 Most Reported
Lactic acidosis
557 reports (6.3%)
All METFORMIN\SITAGLIPTIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Blood glucose increased | 709 | 8.1% | 17 | 150 |
| Acute kidney injury | 616 | 7.0% | 93 | 422 |
| Lactic acidosis | 557 | 6.3% | 132 | 313 |
| No adverse event | 539 | 6.1% | 0 | 1 |
| Diarrhoea | 513 | 5.8% | 24 | 152 |
| Inappropriate schedule of drug administration | 469 | 5.3% | 113 | 186 |
| Product dose omission issue | 452 | 5.1% | 0 | 21 |
| Pancreatic carcinoma | 431 | 4.9% | 280 | 125 |
| Drug ineffective | 384 | 4.4% | 31 | 57 |
| Nausea | 378 | 4.3% | 40 | 118 |
| Diabetes mellitus inadequate control | 364 | 4.1% | 40 | 70 |
| Vomiting | 343 | 3.9% | 32 | 168 |
| Pancreatitis | 307 | 3.5% | 57 | 203 |
| Weight decreased | 284 | 3.2% | 17 | 101 |
| Death | 248 | 2.8% | 247 | 86 |
| Inappropriate schedule of product administration | 245 | 2.8% | 11 | 51 |
| Hypoglycaemia | 240 | 2.7% | 56 | 123 |
| Hyperglycaemia | 236 | 2.7% | 15 | 88 |
| Hyperkalaemia | 233 | 2.6% | 41 | 87 |
| Gastrooesophageal reflux disease | 226 | 2.6% | 59 | 89 |
Who Reports METFORMIN\SITAGLIPTIN Side Effects? Age & Gender Data
Gender: 50.5% female, 49.5% male. Average age: 65.4 years. Most reports from: US. View detailed demographics →
Is METFORMIN\SITAGLIPTIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 0 |
| 2002 | 3 | 0 | 0 |
| 2004 | 1 | 0 | 1 |
| 2005 | 1 | 0 | 0 |
| 2006 | 4 | 1 | 3 |
| 2007 | 26 | 21 | 16 |
| 2008 | 43 | 27 | 27 |
| 2009 | 48 | 31 | 30 |
| 2010 | 72 | 35 | 45 |
| 2011 | 97 | 66 | 62 |
| 2012 | 174 | 83 | 74 |
| 2013 | 271 | 102 | 102 |
| 2014 | 506 | 99 | 224 |
| 2015 | 683 | 103 | 318 |
| 2016 | 527 | 85 | 221 |
| 2017 | 486 | 44 | 172 |
| 2018 | 509 | 75 | 151 |
| 2019 | 463 | 38 | 182 |
| 2020 | 445 | 11 | 170 |
| 2021 | 352 | 18 | 133 |
| 2022 | 277 | 22 | 89 |
| 2023 | 234 | 18 | 102 |
| 2024 | 175 | 7 | 71 |
| 2025 | 99 | 5 | 45 |
What Is METFORMIN\SITAGLIPTIN Used For?
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Official FDA Label for METFORMIN\SITAGLIPTIN
Official prescribing information from the FDA-approved drug label.