Drug profile
Silver Sulfadiazine
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Prompt institution of appropriate regimens for care of the burned patient is of
prime importance and includes the control of shock and pain. The burn wounds are
then cleansed and debrided; silver sulfadiazine cream, USP 1% is then applied
under sterile conditions. The burn areas should be covered with silver
sulfadiazine cream, USP 1% at all times. The cream should be applied once to twice
daily to a thickness of approximately one sixteenth of an inch.
Source: US FDA label for silver (Silver Sulfadiazine), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- Safety and effectiveness in children have not been established. (See
CONTRAINDICATIONS )
Source: US FDA label for silver (Silver Sulfadiazine), section 'pediatric use',
retrieved 2026-08-29
RENAL IMPAIRMENT
- No kidney-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for silver (Silver Sulfadiazine),
retrieved 2026-08-29
HEPATIC IMPAIRMENT
- No liver-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for silver (Silver Sulfadiazine),
retrieved 2026-08-29
PREGNANCY
- TERATOGENIC EFFECTS: Pregnancy Category B.
Source: US FDA label for silver (Silver Sulfadiazine), section 'pregnancy',
retrieved 2026-08-29
- A reproductive study has been performed in rabbits at doses up to three to ten
times the concentration of silver sulfadiazine in silver sulfadiazine cream, USP
1% and has revealed no evidence of harm to the fetus due to silver sulfadiazine.
Source: US FDA label for silver (Silver Sulfadiazine), section 'pregnancy',
retrieved 2026-08-29
- There are, however, no adequate and well-controlled studies in pregnant women.
Source: US FDA label for silver (Silver Sulfadiazine), section 'pregnancy',
retrieved 2026-08-29
BREASTFEEDING
- It is not known whether silver sulfadiazine cream, USP 1% is excreted in human
milk.
Source: US FDA label for silver (Silver Sulfadiazine), section 'nursing mothers',
retrieved 2026-08-29
- However, sulfonamides are known to be excreted in human milk and all sulfonamides
derivatives are known to increase the possibility of kernicterus.
Source: US FDA label for silver (Silver Sulfadiazine), section 'nursing mothers',
retrieved 2026-08-29
- Because of the possibility for serious adverse reactions in nursing infants from
sulfonamides, a decision should be made whether to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug to the
mother.
Source: US FDA label for silver (Silver Sulfadiazine), section 'nursing mothers',
retrieved 2026-08-29