Salicylic Acid: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Salicylic Acid. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Nausea12%
Diarrhea6.8%
Abdominal pain6.8%
Melena3%
Upper respiratory infection2.3%
Constipation1.9%
Anorexia1.5%
Asthenia1.5%
Vomiting1.5%
Discolored tongue*1.5%
Headache1.5%
Dyspepsia1.5%
Dizziness1.5%
Stool abnormality**1.1%
Duodenal ulcer1.1%
Sinusitis1.1%
Taste perversion***1.1%
Flatulence1.1%
Gi hemorrhage1.1%
Pain1.1%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

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…

Source: FDA labeling via NIH DailyMed (set 0c809fa5…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.