Silver Sulfadiazine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: June 17, 2025

Silver Sulfadiazine

Sulfonamides

US FDA

Drug class: Sulfonamides
Availability: Prescription only
Routes: Topical
Markets covered: 1
Products on record: 2
FDA reports (12 mo): 112

D06BASulfonamides

Overview

Plain-language summary, compiled from the cited regulatory records

Silver sulfadiazine is a topical antimicrobial drug belonging to the sulfonamide class [1]. It is approved for use as an adjunct in the prevention and treatment of wound sepsis in individuals with second and third-degree burns [1]. This medication works by inhibiting the growth of a broad spectrum of bacteria, which is crucial in managing burn wound infections [1].

The drug is available under various brand names [N]. In the past 12 months, there have been 112 adverse event reports associated with silver sulfadiazine [2]. The most frequently reported adverse events include off-label use, use in unapproved indications, decreased appetite, diarrhea, and fatigue [2].

This is not medical advice. Consult a qualified healthcare professional.

Regulatory status by market

Market	Regulator	Products	Last revision
US United States	FDA	2	June 17, 2025

USUnited States· FDA

2 products

Uses

USOfficial regulatory label· revised February 10, 2025[1]

INDICATIONS AND USAGE
Silver sulfadiazine cream, USP 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.

How to take

Drug interactions

Known interactions involving Silver Sulfadiazine. Select one for details. This list is informational and not a complete interaction checker.

Prilocaine Benzocaine Cocaine Collagenase Clostridium Histolyticum Lidocaine Proparacaine Tetracaine

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]FDA DailyMed · 0084786a-09a3-46… · revised February 10, 2025 [PDF]
[2]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

USOfficial regulatory label· Adverse reactions· revised February 10, 2025[1]

ADVERSE REACTIONS
Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy. 1,2,3 Leukopenia 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.
An increased 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.
Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial-thickness burns by preventing conversion of the partial thickness to full thickness by sepsis.
However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.

USOfficial regulatory label· Warnings and precautions· revised February 10, 2025[1]

WARNINGS
Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur.
Some of the reactions which have been associated with sulfonamides are as follows: blood dyscrasias including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, and hemolytic anemia; dermatologic and allergic reactions, including life-threatening cutaneous reactions [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and exfoliative dermatitis]; gastrointestinal reactions, hepatitis and hepatocellular necrosis; CNS reactions; and toxic nephrosis.
There is a potential cross-sensitivity between silver sulfadiazine and other sulfonamides. If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction.
Fungal proliferation in and below the eschar may occur. However, the incidence of clinically reported fungal superinfection is low. The use of silver sulfadiazine cream, USP 1% in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

This is not medical advice. Consult a qualified healthcare professional.