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BISMUTH SUBCITRATE POTASSIUM
At a glance
| Generic name | BISMUTH SUBCITRATE POTASSIUM |
|---|---|
| Drug class | Nitroimidazole Antimicrobial [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2006 |
Approved indications
Boxed warnings
- WARNING: POTENTIAL FOR CARCINOGENICITY Metronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans [see Warning and Precautions ( 5.1 ) ] . WARNING: POTENTIAL FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Metronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans ( 5.1 ).
Common side effects
- Abnormal feces
- Diarrhea
- Nausea
- Headache
- Dysgeusia
- Dyspepsia
- Vomiting
- Tongue darkening
- Anxiety
- Gastritis
- Gastroenteritis
- Myalgia
Serious adverse events
- Reversible neutropenia (leucopenia)
- Reversible thrombocytopenia
- QT prolongation
- Acute generalized exanthematous pustulosis (AGEP)
- Pancreatitis
- Convulsive seizures
- Encephalopathy
- Aseptic meningitis
- Optic and peripheral neuropathy
- Duodenal ulcer
Key clinical trials
- Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer (PHASE2)
- Bismuth for PCAB-based H. Pylori Eradication
- The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection (NA)
- Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection (PHASE3)
- Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection (PHASE3)
- Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication (NA)
- Helicobacter Pylori and Body Iron in Adults (PHASE4)
- Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BISMUTH SUBCITRATE POTASSIUM CI brief — competitive landscape report
- BISMUTH SUBCITRATE POTASSIUM updates RSS · CI watch RSS