Haloperidol Pregnancy and Breastfeeding Warnings

Brand names: Haldol, Haldol Decanoate

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Haloperidol Pregnancy Warnings

This drug should be used during pregnancy only if the benefit clearly outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Comments:
-The duration of treatment in pregnant patients should be as short as possible.
-Some experts recommend avoiding use during the first trimester.
-Neonates exposed during the third trimester are at risk of developing severe and/or prolonged side effects (e.g., agitation, hyper/hypotonia, tremor, somnolence, respiratory distress, feeding disorder). The side effects have varied in severity and duration, with some neonates requiring intensive care support and prolonged hospitalization.
-Exposed neonates should be monitored for the signs/symptoms of extrapyramidal syndrome and/or withdrawal.

Animal data have revealed evidence of an increased incidence of resorption, decreased fertility, embryolethality, delayed delivery, decreased brain and body weights, behavioral effects, and pup mortality. Gross malformations (e.g., cleft palate, neural tube defects) occurred in one animal model; these malformations may be the result of concomitant drug exposure, non-specific stress responses, and/or nutritional imbalances. There are reports of limb malformations in infants whose mothers received concomitant drugs with suspected teratogenic potential during the first trimester.

Oral formulations given to male animal models before mating resulted in increased preimplantation loss, decreased fertility, and induced changes in reproductive organs. There are no controlled data in human males.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Haloperidol Breastfeeding Warnings

This drug should not be used unless there are no safer alternatives.

Excreted into human milk: Yes

Comments:
-The American Academy of Pediatrics considers use of this drug in lactation unknown but may be of concern.
-Infants exposed to this drug should be monitored for developmental milestones.

There are isolated cases of extrapyramidal side effects in breastfed infants. In a small study (n=4), breastfed infants had serum concentrations between 0.8 to 2.1 mcg/L after mothers were given doses ranging from 5 to 20 mg. Another study reported that levels of haloperidol in human breast milk were 5 ng/mL after an average maternal dose of 30 mg/day.

See references

Further information

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