FDA
- Status: approved
🇺🇸 SITAGLIPTIN PHOSPHATE in United States
1,948 US adverse-event reports
Marketing authorisations
FDA
- Application: ANDA215155
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA214693
- Marketing authorisation holder: UNICHEM LABS LTD
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA208186
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA214700
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — FILM COATED
- Status: approved
FDA
- Application: ANDA202473
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA202487
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA214784
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA211073
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,948
Most-reported reactions
- Nausea — 267 reports (13.71%)
- Diarrhoea — 253 reports (12.99%)
- Vomiting — 209 reports (10.73%)
- Fatigue — 205 reports (10.52%)
- Blood Glucose Increased — 184 reports (9.45%)
- Malaise — 168 reports (8.62%)
- Asthenia — 166 reports (8.52%)
- Blood Pressure Increased — 166 reports (8.52%)
- Drug Ineffective — 166 reports (8.52%)
- Fall — 164 reports (8.42%)
SITAGLIPTIN PHOSPHATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is SITAGLIPTIN PHOSPHATE approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for SITAGLIPTIN PHOSPHATE in United States?
Marketing authorisation holder not available in our data.