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Bismuth Side Effects

The most commonly reported side effects of bismuth include nausea, diarrhoea, and vomiting, based on 2,331 FDA adverse event reports from 2004 to 2025. 4.4% of reports found the drug to be ineffective.

Bismuth side effects

Percentages show how often each reaction appears relative to total reports for bismuth.

1
Nausea10.2%237
2
Diarrhoea8.0%186
3
Vomiting7.4%172
4
Off Label Use6.9%161
5
Abdominal Pain6.1%142
6
Headache6.0%140
7
Pruritus5.5%128
8
Dyspnoea5.1%118
9
Somnolence4.5%104
10
Asthenia4.4%103
11
Drug Ineffective4.4%103
12
Dizziness4.2%98
13
Abdominal Distension4.2%98
14
Constipation4.1%95
15
Pyrexia4.0%94

These are voluntary reports and do not establish that bismuth caused these reactions.

Report severity

83.0%Serious1,934 reports
39.2%Hospitalizations913 reports
10.0%Fatal233 reports

Seriousness is determined by the reporter, not by OpenClaim.

Bismuth drug interactions

Other drugs that appear in adverse event reports alongside bismuth. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Metronidazole49.8%1,161
2
Tetracycline43.8%1,022
3
Omeprazole15.0%349
4
Amoxicillin9.7%225
5
Lansoprazole8.6%201
6
Furazolidone7.4%172
7
Rabeprazole-sodium6.6%153
8
Acetaminophen6.5%151
9
Clarithromycin5.7%133
10
Insulin5.0%116
11
Pantoprazole-sodium4.7%109
12
Esomeprazole4.6%107
13
Ondansetron4.5%105
14
Gabapentin4.5%104
15
Warfarin4.4%103

Taken alongside

1
Acetaminophen11.5%269
2
Omeprazole11.4%266
3
Metronidazole8.8%204
4
Ergocalciferol8.5%198
5
Tetracycline8.2%192
6
Aspirin8.1%189
7
Pantoprazole-sodium7.3%169
8
Amlodipine6.9%162
9
Ondansetron5.7%133
10
Levothyroxine-sodium5.3%124
11
Albuterol5.1%118
12
Atorvastatin-calcium4.8%113
13
Ibuprofen4.6%108
14
Loperamide-hydrochloride4.6%107
15
Metformin4.5%106

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports bismuth side effects

54.3% of bismuth adverse event reports involve female patients and 37.9% involve male patients. The largest age group is adult at 66%. These figures reflect who reports side effects, not underlying risk.

Sex

Female54.3%
Male37.9%
Unknown7.8%

Age group

< 20.1%
2–110.5%
12–171.3%
18–6466.1%
65+32.0%

What is bismuth used for

Conditions and purposes for which patients were taking bismuth when the adverse event was reported.

Abdominal DiscomfortAbdominal InfectionAbdominal PainAbdominal Pain UpperAnal FissureAntacid TherapyAntidiarrhoeal Supportive CareAnxietyAbdominal DiscomfortAbdominal PainAdverse EventAnaemiaAnalgesic TherapyAntacid TherapyBacterial Infection

Showing 15 of 120 indications

Bismuth brand names and reporting trend

Bismuth is sold under brand names including Helidac, Pylera.

Brand names

Helidac762
Pylera664

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking bismuth with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.