Drug profile
Nitroglycerin
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Apply 1 inch of ointment (375 mg of ointment equivalent to 1.5 mg of
nitroglycerin) intra-anally every 12 hours for up to 3 weeks.
Source: US FDA label for nitroglycerin (NITROGLYCERIN), section 'dosage and
administration', retrieved 2026-08-29
- To obtain a 1.5 mg dose of nitroglycerin, the covered finger is laid alongside the
1-inch dosing line on the carton.
Source: US FDA label for nitroglycerin (NITROGLYCERIN), section 'dosage and
administration', retrieved 2026-08-29
- Apply 1 inch of ointment (375 mg of ointment equivalent to 1.5 mg of
nitroglycerin) intra-anally every 12 hours for up to 3 weeks ( 2 ).
Source: US FDA label for nitroglycerin (NITROGLYCERIN), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- The safety and effectiveness of nitroglycerin ointment, 0.4% in pediatric patients
under 18 years of age have not been established.
Source: US FDA label for nitroglycerin (NITROGLYCERIN), 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 nitroglycerin (NITROGLYCERIN),
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 nitroglycerin (NITROGLYCERIN),
retrieved 2026-08-29
PREGNANCY
- Pregnancy Category C Animal reproduction and teratogenicity studies have not been
conducted with nitroglycerin ointment, 0.4%.
Source: US FDA label for nitroglycerin (NITROGLYCERIN), section 'pregnancy',
retrieved 2026-08-29
- Nitroglycerin was not teratogenic when administered by topical or dietary route.
Source: US FDA label for nitroglycerin (NITROGLYCERIN), section 'pregnancy',
retrieved 2026-08-29
- There are no adequate and well-controlled studies in pregnant women.
Source: US FDA label for nitroglycerin (NITROGLYCERIN), section 'pregnancy',
retrieved 2026-08-29
BREASTFEEDING [ CAUTION ]
The label allows it only when the benefit is judged to outweigh the risk. Read the
quote below.
- It is not known whether nitroglycerin is excreted in human milk.
Source: US FDA label for nitroglycerin (NITROGLYCERIN), section 'nursing mothers',
retrieved 2026-08-29
- Because many drugs are excreted in human milk, caution should be exercised when
nitroglycerin ointment, 0.4% is administered to a nursing woman.
Source: US FDA label for nitroglycerin (NITROGLYCERIN), section 'nursing mothers',
retrieved 2026-08-29
- The latter finding probably reflects delayed development, thus indicating no clear
evidence of a potential teratogenic effect of nitroglycerin. 8.3 Nursing Mothers
It is not known whether nitroglycerin is excreted in human milk.
Source: US FDA label for nitroglycerin (NITROGLYCERIN), section 'use in specific
populations', retrieved 2026-08-29