What the label lists and what reports show
Talc side effects
Talc's FDA label lists its adverse reactions in its own words. FAERS holds 420 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is exposure to chemical pollution (305 reports).
- No generic listed
Check it at the source: the talc FDA label on DailyMed (effective June 25, 2025); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling. Pneumonitis and Acute Respiratory Distress Syndrome (ARDS) [see Warnings and Precautions (5.1)] Lead Content [see Warnings and Precautions (5.3)] Asbestos Content [see Warnings and Precautions (5.4)] Common adverse reactions observed with intrapleural use of various talc products are fever and pain. Other adverse reactions include dyspnea, arrhythmia, empyema, pneumonitis and acute respiratory distress syndrome (ARDS). Procedure related adverse reactions such as bleeding, hemothorax, wound infections, atelectasis and pneumonia may occur. _____________ ADVERSE REACTIONS _____________ Common adverse reactions are fever and pain. (6) To report suspected adverse reactions contact Boston Medical Product Inc., at 508-898-9300 and FDA at 1-800-332-1088 or www.fda.gov/medwatch.
Source: FDA drug label, Novatech SA, effective June 25, 2025 (SPL set c94e51d9-beef-4b06-e053-2a95a90a754a), via openFDA; the full label on DailyMed
What do FAERS reports show?
420 reports list talc among the medicines taken, each a report of something that happened, not proof the medicine caused it; 108 are coded as a death and 45 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 24 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Talc: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions