Salicylic Acid: Side Effects, Uses & Monitoring
The components of Bismuth Subsalicylate Chewable Tablets/ Metronidazole Tablets/Tetracycline Hydrochloride Capsules (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride), in combination with an H2 antago
- Data source
- FDA labeling via NIH DailyMed (label 0c809fa5…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Nausea | 12% |
| Diarrhea | 6.8% |
| Abdominal pain | 6.8% |
| Melena | 3% |
| Upper respiratory infection | 2.3% |
| Constipation | 1.9% |
| Anorexia | 1.5% |
| Asthenia | 1.5% |
| Vomiting | 1.5% |
| Discolored tongue* | 1.5% |
| Headache | 1.5% |
| Dyspepsia | 1.5% |
| Dizziness | 1.5% |
| Stool abnormality** | 1.1% |
| Duodenal ulcer | 1.1% |
| Sinusitis | 1.1% |
| Taste perversion*** | 1.1% |
| Flatulence | 1.1% |
| Gi hemorrhage | 1.1% |
| Pain | 1.1% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
The components of Bismuth Subsalicylate Chewable Tablets/ Metronidazole Tablets/Tetracycline Hydrochloride Capsules (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride), in combination with an H2 antagonist, are indicated for the eradication of H. pylori for treatment of patients with H. pylori infection and duodenal ulcer disease (active or a history of duodenal ulcer). The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence in patients with active duodenal ulcer disease (see CLINICAL STUDIES and DOSAGE AND ADMINISTRATION ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules and other antibacterial drugs, Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local…
Conditions associated with Salicylic Acid in labeling
Frequently Asked Questions
What is Salicylic Acid used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Salicylic Acid?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Salicylic Acid. Individual risk varies.
Does Salicylic Acid require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Salicylic Acid.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.