Drug profile
Chloramphenicol
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- No adult dose in this label - read the full label before dosing.
Source: Read and found silent: the US FDA label for chloramphenicol
(Chloramphenicol Sodium Succinate), retrieved 2026-08-29
CHILD
- Precaution should be used in therapy of premature and full-term neonates and
infants to avoid “gray syndrome” toxicity. Due to immature metabolic processes in
the neonate and infant, excessive blood levels may result from administration of
the recommended dose. The dosage should be adjusted accordingly or, preferable,
the blood concentration should be determined at appropriate intervals (see ADVERSE
REACTIONS , "Gray Syndrome" ).
Source: US FDA label for chloramphenicol (Chloramphenicol Sodium Succinate),
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 chloramphenicol
(Chloramphenicol Sodium Succinate), 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 chloramphenicol
(Chloramphenicol Sodium Succinate), retrieved 2026-08-29
PREGNANCY
- Pregnancy Category C – Animal reproduction studies have not been conducted with
chloramphenicol.
Source: US FDA label for chloramphenicol (Chloramphenicol Sodium Succinate),
section 'pregnancy', retrieved 2026-08-29
- There are no adequate and well-controlled studies to establish safety of this drug
in pregnancy.
Source: US FDA label for chloramphenicol (Chloramphenicol Sodium Succinate),
section 'pregnancy', retrieved 2026-08-29
- It is not known whether chloramphenicol can cause fetal harm when administered to
a pregnant woman.
Source: US FDA label for chloramphenicol (Chloramphenicol Sodium Succinate),
section 'pregnancy', retrieved 2026-08-29
BREASTFEEDING
- Chloramphenicol is excreted in human milk following oral administration of the
drug.
Source: US FDA label for chloramphenicol (Chloramphenicol Sodium Succinate),
section 'nursing mothers', retrieved 2026-08-29
- Because of the potential for serious adverse reactions in nursing infants from
chloramphenicol, 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
(see ADVERSE REACTIONS, “Gray Syndrome” ).
Source: US FDA label for chloramphenicol (Chloramphenicol Sodium Succinate),
section 'nursing mothers', retrieved 2026-08-29