🇺🇸 Nifedipine GITS in United States

18 US adverse-event reports

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: 22 April 2025 – 22 April 2026
• Total reports: 18

Most-reported reactions

1. Endometritis — 2 reports (11.11%)
2. Foetal Death — 2 reports (11.11%)
3. Foetal Growth Restriction — 2 reports (11.11%)
4. Hypertension — 2 reports (11.11%)
5. Maternal Exposure During Pregnancy — 2 reports (11.11%)
6. Muscular Weakness — 2 reports (11.11%)
7. Off Label Use — 2 reports (11.11%)
8. Pre-Eclampsia — 2 reports (11.11%)
9. Aphasia — 1 report (5.56%)
10. Arteriosclerosis — 1 report (5.56%)

Source database →

Frequently asked questions

Is Nifedipine GITS approved in United States?

Nifedipine GITS does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Nifedipine GITS in United States?

Peking University First Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.