Drug profile
Clopidogrel
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Initiate aspirin (75 to 325 mg once daily) and continue in combination with
clopidogrel tablets [ see Clinical Studies ( 14.1 ) ]. • For patients with STEMI,
the recommended dose of clopidogrel tablets is 75 mg once daily orally,
administered in combination with aspirin (75 to 325 mg once daily), with or
without thrombolytics.
Source: US FDA label for clopidogrel (Clopidogrel), section 'dosage and
administration', retrieved 2026-08-29
- Clopidogrel tablets may be initiated with or without a loading dose [ see Clinical
Studies ( 14.1 ) ]. 2.2 Recent MI, Recent Stroke, or Established Peripheral
Arterial Disease The recommended daily dose of clopidogrel tablets is 75 mg once
daily orally, with or without food [ see Clinical Pharmacology ( 12.3 ) ]. 2.3
CYP2C19 Poor Metabolizers CYP2C19 poor metabolizer status is associated with
diminished antiplatelet response to clopidogrel.
Source: US FDA label for clopidogrel (Clopidogrel), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- Safety and effectiveness in pediatric populations have not been established. A
randomized, placebo-controlled trial (CLARINET) did not demonstrate a clinical
benefit of clopidogrel in neonates and infants with cyanotic congenital heart
disease palliated with a systemic-to-pulmonary arterial shunt.
Source: US FDA label for clopidogrel (Clopidogrel), section 'pediatric use',
retrieved 2026-08-29
RENAL IMPAIRMENT
- No dosage adjustment is necessary in elderly patients. 8.6 Renal Impairment
Experience is limited in patients with severe and moderate renal impairment [ see
Clinical Pharmacology ( 12.2 ) ]. 8.7 Hepatic Impairment No dosage adjustment is
necessary in patients with hepatic impairment [ see Clinical Pharmacology ( 12.2 )
].
Source: US FDA label for clopidogrel (Clopidogrel), section 'use in specific
populations', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- No dosage adjustment is necessary in elderly patients. 8.6 Renal Impairment
Experience is limited in patients with severe and moderate renal impairment [ see
Clinical Pharmacology ( 12.2 ) ]. 8.7 Hepatic Impairment No dosage adjustment is
necessary in patients with hepatic impairment [ see Clinical Pharmacology ( 12.2 )
].
Source: US FDA label for clopidogrel (Clopidogrel), section 'use in specific
populations', retrieved 2026-08-29
PREGNANCY [ CAUTION ]
The label allows it only when the benefit is judged to outweigh the risk. Read the
quote below.
- Teratogenic Effects Pregnancy Category B Reproduction studies performed in rats
and rabbits at doses up to 500 and 300 mg/kg/day, respectively (65 and 78 times
the recommended daily human dose, respectively, on a mg/m 2 basis), revealed no
evidence of impaired fertility or fetotoxicity due to clopidogrel.
Source: US FDA label for clopidogrel (Clopidogrel), section 'pregnancy', retrieved
2026-08-29
- There are, however, no adequate and well-controlled studies in pregnant women.
Source: US FDA label for clopidogrel (Clopidogrel), section 'pregnancy', retrieved
2026-08-29
- Because animal reproduction studies are not always predictive of a human response,
clopidogrel should be used during pregnancy only if clearly needed.
Source: US FDA label for clopidogrel (Clopidogrel), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- Studies in rats have shown that clopidogrel and/or its metabolites are excreted in
the milk.
Source: US FDA label for clopidogrel (Clopidogrel), section 'nursing mothers',
retrieved 2026-08-29
- It is not known whether this drug is excreted in human milk.
Source: US FDA label for clopidogrel (Clopidogrel), section 'nursing mothers',
retrieved 2026-08-29
- Because many drugs are excreted in human milk and because of the potential for
serious adverse reactions in nursing infants from clopidogrel, 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 clopidogrel (Clopidogrel), section 'nursing mothers',
retrieved 2026-08-29