Drug profile
Mupirocin
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- • For Topical Use Only. • Apply a small amount of PIRNUO cream, with a cotton swab
or gauze pad, to the affected area 3 times daily for 10 days. • Cover the treated
area with gauze dressing if desired. • Re-evaluate patients not showing a clinical
response within 3 to 5 days. • PIRNUO cream is not for intranasal, ophthalmic, or
other mucosal use [see Warnings and Precautions ( 5.2 , 5.6 )] .
Source: US FDA label for mupirocin (Pirnuo), section 'dosage and administration',
retrieved 2026-08-29
CHILD
- The safety and effectiveness of mupirocin cream have been established in the age-
groups of 3 months to 16 years. Use of PIRNUO cream in these age-groups is
supported by evidence from adequate and well-controlled trials of mupirocin cream
in adults with additional data from 93 pediatric subjects studied as part of the
pivotal trials in adults [see Clinical Studies ( 14 )] .
Source: US FDA label for mupirocin (Pirnuo), 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 mupirocin (Pirnuo), 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 mupirocin (Pirnuo), retrieved
2026-08-29
PREGNANCY
- Risk Summary There are insufficient human data to establish whether there is a
drug-associated risk with mupirocin cream in pregnant women.
Source: US FDA label for mupirocin (Pirnuo), section 'pregnancy', retrieved
2026-08-29
- Systemic absorption of mupirocin through intact human skin is minimal following
topical administration of mupirocin cream [see Clinical Pharmacology (12.3)] .
Source: US FDA label for mupirocin (Pirnuo), section 'pregnancy', retrieved
2026-08-29
- No developmental toxicity was observed in rats or rabbits treated with mupirocin
subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day,
respectively (22 and 11 times the human topical dose based on calculations of dose
divided by the entire body surface area).
Source: US FDA label for mupirocin (Pirnuo), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- Mupirocin administered subcutaneously to rats in a pre- and postnatal development
study (dosed during late gestation through lactation) was associated with reduced
offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in
the presence of injection site irritation and/or subcutaneous hemorrhaging.
Source: US FDA label for mupirocin (Pirnuo), section 'use in specific
populations', retrieved 2026-08-29
- The no-observed adverse effect level in this study was 44.2 mg per kg per day,
which is 6 times the human topical dose. 8.2 Lactation Risk Summary It is not
known whether mupirocin is present in human milk, has effects on the breastfed
child, or has effects on milk production.
Source: US FDA label for mupirocin (Pirnuo), section 'use in specific
populations', retrieved 2026-08-29
- The developmental and health benefits of breastfeeding should be considered along
with the mother’s clinical need for PIRNUO cream and any potential adverse effects
on the breastfed child from PIRNUO cream or from the underlying maternal
condition.
Source: US FDA label for mupirocin (Pirnuo), section 'use in specific
populations', retrieved 2026-08-29