Over-the-counter medication · Antidiarrheal / Antacid
bismuth subsalicylate
Also sold as Pepto-Bismol. This medicine can help with traveler's diarrhea.
Data updated 2026-05-15
- 5,567
- FDA reportsLightly reported
- 3
- InteractionsFew interactions
- $0.08
- Generic price (NADAC)
What the data shows
bismuth subsalicylate (Pepto-Bismol) is an over-the-counter Antidiarrheal / Antacid, reported less often than most tracked drugs (5,567 FDA reports), with 3 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
bismuth subsalicylate (Pepto-Bismol) is an over-the-counter Antidiarrheal / Antacid. This medicine can help with traveler's diarrhea.
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach. It works as both an antidiarrheal and an antacid.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.08/unit
Generic Available
Yes (2 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine can help with traveler's diarrhea.
Common side effects
Diarrhea, Nausea, Vomiting
Key warnings
Ask a doctor before giving this medicine to children under 12 years old.
The sections below are summarized in plain English from bismuth subsalicylate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Bismuth subsalicylate works by coating your stomach and intestines. This helps to reduce inflammation and kill certain bacteria that can cause diarrhea. It also helps to reduce the amount of fluid that is secreted into your digestive tract.
Side Effects (from patient reports)
Based on 5,567 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for bismuth subsalicylate, by number of reports
- Chronic Kidney Disease
Chronic Kidney Disease
1,418 reports
- Acute Kidney Injury
Acute Kidney Injury
822 reports
- Renal Failure
Renal Failure
724 reports
- Diarrhoea
Diarrhoea
711 reports
- Nausea
Nausea
615 reports
- End Stage Renal Disease 462
End Stage Renal Disease
462 reports
- Vomiting 399
Vomiting
399 reports
- Fatigue 368
Fatigue
368 reports
- Renal Injury 327
Renal Injury
327 reports
- Gastrooesophageal Reflux Disease 311
Gastrooesophageal Reflux Disease
311 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for bismuth subsalicylate each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where bismuth subsalicylate sits
bismuth subsalicylate has more FDA adverse-event reports than 26% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is bismuth subsalicylate; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 5,567 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
5,567
Reports Mentioning Death
516
9.3% of reports — not proof of cause
Hospitalization Reports
1,477
Top Indication
Gastrooesophageal Reflux Disease
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | CHRONIC KIDNEY DISEASE | 1,418 |
| 2 | ACUTE KIDNEY INJURY | 822 |
| 3 | RENAL FAILURE | 724 |
| 4 | DIARRHOEA | 711 |
| 5 | NAUSEA | 615 |
| 6 | END STAGE RENAL DISEASE | 462 |
| 7 | VOMITING | 399 |
| 8 | FATIGUE | 368 |
| 9 | RENAL INJURY | 327 |
| 10 | GASTROOESOPHAGEAL REFLUX DISEASE | 311 |
| 12 | DEPRESSION | 281 |
| 13 | CONSTIPATION | 259 |
| 14 | PAIN | 255 |
| 16 | ABDOMINAL PAIN | 241 |
| 17 | ABDOMINAL PAIN UPPER | 239 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Ask a doctor before giving this medicine to children under 12 years old.
Known Drug Interactions
Absorption of tetracyclines is impaired by bismuth subsalicylate.
Mechanism: Bismuth subsalicylate prevents your body from properly absorbing the antibiotic into your bloodstream.
Absorption of tetracyclines is impaired by bismuth subsalicylate.
Mechanism: Bismuth subsalicylate stops your body from absorbing doxycycline into your blood. This can prevent the antibiotic from working to kill bacteria.
( 7.1 ) Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. 7.2 Antacids and Iron Preparations Absorption of oral tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron containing preparations [see Dosage and Administration (2.1) ].
Mechanism: Bismuth subsalicylate interferes with how your body takes in the antibiotic, making the medicine less effective at fighting infection.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
How often can I take this medicine?
Can children take this medicine?
How long should I take this medicine?
What should I drink while taking this medicine?
What do I do if I overdose?
Can I take this with other medicines?
What if my symptoms don't improve?
Can this medicine cause side effects?
How should I store this medicine?
What does this medicine treat?
What are the common side effects of bismuth subsalicylate?
Does bismuth subsalicylate interact with other medications?
What drug class is bismuth subsalicylate?
What pregnancy or breastfeeding source fields are listed for bismuth subsalicylate?
Related Medications in Antidiarrheal / Antacid
Other drugs grouped near bismuth subsalicylate - same-class peers and common alternatives.
alosetron
Lotronex
Alosetron (Lotronex) is a medicine for women with severe diarrhea-predominant irritable bowel syndrome (IBS).
Compare with bismuth subsalicylate →
aprepitant
Emend
Aprepitant (Emend) is a medicine that helps prevent nausea and vomiting.
Compare with bismuth subsalicylate →
bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
Compare with bismuth subsalicylate →
cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with bismuth subsalicylate →
dexlansoprazole
Dexilant
Dexlansoprazole (Dexilant) is a medicine that lowers stomach acid.
Compare with bismuth subsalicylate →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for bismuth subsalicylate: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 5,567.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.27%.
- linagliptin Δ 0.01 pts · 17,378 reports · DPP-4 Inhibitor 9.28%death share
- ketoprofen Δ 0.03 pts · 12,302 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 9.23%death share
- aspirin Δ 0.05 pts · 518,554 reports · Antiplatelet / NSAID 9.22%death share
- molnupiravir Δ 0.05 pts · 5,119 reports · Nucleoside Analog (Antiviral) 9.22%death share
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Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for bismuth subsalicylate
The FDA label for bismuth subsalicylate (sold under brand names such as Pepto-Bismol) classifies it as an over-the-counter product in the Antidiarrheal / Antacid class. This medicine can help with traveler's diarrhea. Official labeling lists 5 commonly reported side effects, including Diarrhea, Nausea, Vomiting.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 5,567 voluntary reports. The database also lists 3 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.08.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: November 7, 2018
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages