Sitagliptin / Metformin Hydrochloride

Common brands: Janumet Xr, Janumet, Metformin Hydrochloride, Aspirin 325, Aspirin 81

Top reporter: Merck Sharp & Dohme Llc

Nonsteroidal Anti-inflammatory Drug [EPC]Insulin Analog [EPC]HMG-CoA Reductase Inhibitor [EPC]Platelet Aggregation Inhibitor [EPC]Sulfonylurea [EPC]
21,335
Total Reports
5,693
Serious Reports
2,100
Death Reports
30
Reported Reactions
Death Report Ratio: High (9.84%)

Patient Demographics

Male
9,928
Female
9,904

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Sitagliptin / Metformin Hydrochloride.

# Reaction Reports % of Total
1 BLOOD GLUCOSE INCREASED 1,502
7.6%
2 DIARRHOEA 1,377
6.9%
3 NAUSEA 1,095
5.5%
4 DRUG INEFFECTIVE 990
5.0%
5 FATIGUE 890
4.5%
6 ACUTE KIDNEY INJURY 822
4.1%
7 VOMITING 767
3.9%
8 WEIGHT DECREASED 709
3.6%
9 DIZZINESS 634
3.2%
10 PANCREATITIS 626
3.2%
11 DYSPNOEA 617
3.1%
12 INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 617
3.1%
13 NO ADVERSE EVENT 605
3.1%
14 OFF LABEL USE 594
3.0%
15 DEATH 591
3.0%
16 PANCREATIC CARCINOMA 588
3.0%
17 PRODUCT DOSE OMISSION ISSUE 582
2.9%
18 HEADACHE 580
2.9%
19 ASTHENIA 567
2.9%
20 LACTIC ACIDOSIS 549
2.8%
21 PAIN 509
2.6%
22 MALAISE 508
2.6%
23 FALL 472
2.4%
24 HYPERTENSION 456
2.3%
25 PRURITUS 455
2.3%
26 ARTHRALGIA 454
2.3%
27 ABDOMINAL PAIN 423
2.1%
28 DIABETES MELLITUS INADEQUATE CONTROL 417
2.1%
29 DECREASED APPETITE 411
2.1%
30 PAIN IN EXTREMITY 406
2.0%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.