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bismuth subsalicylate

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Brand names: Pepto-Bismol

Antidiarrheal / Antacid OTC

Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach. It works as both an antidiarrheal and an antacid.

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.

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.

How to Take It

Chew the tablets or let them dissolve in your mouth. Adults and children over 12 years can take 2 tablets every 30 minutes or 4 tablets every hour as needed for diarrhea. For upset stomach, heartburn, indigestion, or nausea, take 2 tablets every 30 minutes as needed. Do not take more than 16 tablets in 24 hours. Drink plenty of clear fluids to avoid dehydration.

Pregnancy & Breastfeeding

Ask a doctor if it is safe for you to take this medicine while pregnant or breastfeeding. It is not known if this medicine will harm your unborn baby or pass into your breast milk.

Missed Dose

Take the missed dose as soon as you remember. Do not take more than the maximum daily dose.

Storage

Store at room temperature away from moisture and heat.

Side Effects (from patient reports)

Based on 6,157 FDA adverse event reports.

Long-term kidney disease
1,418
Sudden kidney damage
822
Kidney failure
724
Diarrhea
711
Nausea
615
Kidney failure requiring dialysis
462
Vomiting
399
Tiredness
368
Kidney damage
327
Acid reflux
311

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

Death-Related Reports

516

Hospitalization Reports

1,477

Top Indication

Gastrooesophageal Reflux Disease

Gender Distribution

Female 3,059 (62%)
Male 1,845 (38%)

Age Distribution

0–17 58
18–44 642
45–64 1,288
65–74 639
75+ 590

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
11 DRUG INEFFECTIVE 286
12 DEPRESSION 281
13 CONSTIPATION 259
14 PAIN 255
15 OFF LABEL USE 243

Reactions in Death Reports

DEATH 182
CHRONIC KIDNEY DISEASE 150
END STAGE RENAL DISEASE 130
ACUTE KIDNEY INJURY 120
RENAL FAILURE 98
NAUSEA 91
VOMITING 87
ABDOMINAL DISTENSION 77
ABDOMINAL PAIN 75
OFF LABEL USE 73

Reactions in Hospitalization Reports

NAUSEA 227
DIARRHOEA 202
VOMITING 198
CHRONIC KIDNEY DISEASE 197
ACUTE KIDNEY INJURY 196
RENAL FAILURE 167
OSTEOPOROSIS 140
ABDOMINAL PAIN 136
DYSPNOEA 132
FALL 121

Source: FDA FAERS (Adverse Event Reporting System) 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.

What to do: Talk to your doctor about how to time these medications so the antibiotic can be absorbed correctly.

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.

What to do: Do not take these two medicines at the exact same time. Ask your doctor or pharmacist how to space them out during the day.

( 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.

What to do: Avoid taking these two medicines at the same time so the antibiotic can work correctly.

Common Questions

How often can I take this medicine?
Adults and children over 12 can take a dose every 30 minutes to an hour as needed, but do not exceed 16 tablets in 24 hours.
Can children take this medicine?
Children under 12 should ask a doctor before use.
How long should I take this medicine?
Use until diarrhea stops, but for no more than 2 days.
What should I drink while taking this medicine?
Drink plenty of clear fluids to prevent dehydration.
What do I do if I overdose?
Seek medical attention right away.
Can I take this with other medicines?
Ask a doctor or pharmacist before taking this with other medicines.
What if my symptoms don't improve?
Talk to your doctor if your symptoms do not improve after 2 days.
Can this medicine cause side effects?
Yes, like all medicines, this can cause side effects. Common side effects are listed above.
How should I store this medicine?
Store at room temperature away from moisture and heat.
What does this medicine treat?
This medicine treats diarrhea and upset stomach.
What are the common side effects of bismuth subsalicylate?
The most commonly reported side effects of bismuth subsalicylate include Diarrhea, Nausea, Vomiting, Headache, Constipation. Based on 6,157 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does bismuth subsalicylate interact with other medications?
Yes, bismuth subsalicylate has 3 known drug interactions. Notable interactions include doxycycline, doxycycline hyclate, omadacycline. Always inform your doctor about all medications you are taking.
What drug class is bismuth subsalicylate?
bismuth subsalicylate belongs to the Antidiarrheal / Antacid drug class. It is available over the counter (OTC). This medicine can help with traveler's diarrhea.
Is bismuth subsalicylate safe during pregnancy?
Ask a doctor if it is safe for you to take this medicine while pregnant or breastfeeding. It is not known if this medicine will harm your unborn baby or pass into your breast milk. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Related Medications in Antidiarrheal / Antacid

Other drugs grouped near bismuth subsalicylate — same-class peers and common alternatives.

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Medication Guides

Related Health & Safety Data

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 6,157 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: November 7, 2018

All federal data sources used on this page