What the label lists and what reports show
Silver sulfadiazine side effects
Silver sulfadiazine's FDA label lists its adverse reactions in its own words. FAERS holds 2,276 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 pain (154 reports).
- No generic listed
Check it at the source: the silver sulfadiazine FDA label on DailyMed (effective April 24, 2019, Dr Reddys Laboratories Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsSeveral cases of transient leucopenia have been reported in patients receiving silver sulfadiazine therapy. Leucopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurs within two to four days of initiation of therapy. Rebound to normal leukocyte levels follows onset within two to three days. Recovery is not influenced by continuation of silver sulfadiazine therapy. The incidence of leucopenia in various reports averages about 20%. A higher incidence has been seen in patients treated concurrently with cimetidine. Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis. …
Source: FDA drug label, Dr Reddys Laboratories Inc, effective April 24, 2019 (SPL set 30d6dc33-e457-466b-9159-d8e7cd791820), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,276 reports list silver sulfadiazine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 291 are coded as a death and 784 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 20 reactions below, 1 is 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.
Reports received each year
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?
- Silver sulfadiazine: 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