FDA — authorised 28 September 2006
- Application: NDA050786
- Marketing authorisation holder: LABS JUVISE
- Status: supplemented
🇺🇸 BISMUTH SUBCITRATE POTASSIUM in United States
FDA authorised BISMUTH SUBCITRATE POTASSIUM on 28 September 2006 · 37 US adverse-event reports
Marketing authorisations
FDA — authorised 6 March 2023
- Application: ANDA205770
- Marketing authorisation holder: PH HEALTH
- Local brand name: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 July 2023
- Application: ANDA217511
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- 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: 37
Most-reported reactions
- Headache — 5 reports (13.51%)
- Nausea — 5 reports (13.51%)
- Decreased Appetite — 4 reports (10.81%)
- Diarrhoea — 4 reports (10.81%)
- Dizziness — 4 reports (10.81%)
- Dysgeusia — 3 reports (8.11%)
- Malaise — 3 reports (8.11%)
- Muscular Weakness — 3 reports (8.11%)
- Off Label Use — 3 reports (8.11%)
- Paraesthesia — 3 reports (8.11%)
BISMUTH SUBCITRATE POTASSIUM 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 BISMUTH SUBCITRATE POTASSIUM approved in United States?
Yes. FDA authorised it on 28 September 2006; FDA authorised it on 6 March 2023; FDA authorised it on 3 July 2023.
Who is the marketing authorisation holder for BISMUTH SUBCITRATE POTASSIUM in United States?
LABS JUVISE holds the US marketing authorisation.