The Basics
What is Haloperidol?
Used to treat severe behavioral problems in children who cannot be treated with psychotherapy or with other medications.
Brand names for Haloperidol
Haldol
How Haloperidol is classified
Antipsychotic Agents, Butyrophenones
Haloperidol During Pregnancy
Haloperidol pregnancy category
Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Haloperidol while pregnant
Rodents given 2 to 20 times the usual maximum human dose of haloperidol by oral or parenteral routes showed an increase in incidence of resorption, reduced fertility, delayed delivery and pup mortality. No teratogenic effect has been reported in rats, rabbits or dogs at dosages within this range, but cleft palate has been observed in mice given 15 times the usual maximum human dose. Cleft palate in mice appears to be a nonspecific response to stress or nutritional imbalance as well as to a variety of drugs, and there is no evidence to relate this phenomenon to predictable human risk for most of these agents. There are no well controlled studies with HALDOL (haloperidol) in pregnant women. There are reports, however, of cases of limb malformations observed following maternal use of HALDOL along with other drugs which have suspected teratogenic potential during the first trimester of pregnancy. Causal relationships were not established in these cases. Since such experience does not exclude the possibility of fetal damage due to HALDOL, this drug should be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus. Infants should not be nursed during drug treatment. Non-Teratogenic Effects Neonates exposed to antipsychotic drugs (including haloperidol) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been selflimited, in other cases neonates have required intensive care unit support and prolonged hospitalization. HALDOL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Taking Haloperidol While Breastfeeding
What are recommendations for lactation if you're taking Haloperidol?
Limited information indicates that maternal doses of haloperidol up to 10 mg daily produce low levels in milk and usually do not affect the breastfed infant. Very limited long-term follow-up data indicate no adverse developmental effects when haloperidol is used alone. However, use with other antipsychotic drugs occasionally might negatively affect the infant. Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.
Maternal / infant drug levels
Limited information indicates that maternal doses of haloperidol up to 10 mg daily produce low levels in milk and usually do not affect the breastfed infant. Very limited long-term follow-up data indicate no adverse developmental effects when haloperidol is used alone. However, use with other antipsychotic drugs occasionally might negatively affect the infant. Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.
Possible effects of Haloperidol on milk supply
Galactorrhea has been reported with haloperidol.[11] Hyperprolactinemia appears to be the cause of the galactorrhea.[11][12][13][14][15][16] The hyperprolactinemia is caused by the drug’s dopamine-blocking action in the tuberoinfundibular pathway.[17] The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Possible alternatives to Haloperidol
Olanzapine, Risperidone.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Stewart RB, Karas B, Springer PK. Haloperidol excretion in human milk. Am J Psychiatry. 1980;137:849-50. PMID: 7386670
2. Whalley LJ, Blain PG, Prime JK. Haloperidol secreted in breast milk. Br Med J. 1981;282:1746-7. PMID: 6786603
3. Kuniyoshi M, Inanaga K. Haloperidol and biperiden plasma levels in a pregnant atypical psychotic woman and a neonate–a case report. Kurume Med J. 1985;32:199-202. PMID: 3835398
4. Ohkubo T, Shimoyama R, Sugawara K. Measurement of haloperidol in human breast milk by high-performance liquid chromatography. J Pharm Sci. 1992;81:947-9. PMID: 1432646
5. Sugawara K, Shimoyama R, Ohkubo T. Determinations of psychotropic drugs and antiepileptic drugs by high-performance liquid chromatography and its monitoring in human breast milk. Hirosaki Med J. 1999;51(Suppl):S81-6.
6. Yoshida K, Smith B, Craggs M et al. Neuroleptic drugs in breast-milk: a study of pharmacokinetics and of possible adverse effects in breast-fed infants. Psychol Med. 1998;28:81-91. PMID: 9483685
7. Yoshida K, Smith B, Craggs M et al. Investigation of pharmacokinetics and possible adverse effects in infants exposed to tricyclic antidepressants in breast-milk. J Affective Disord. 1997;43:225-37. PMID: 9186793
8. Mendhekar DN, Andrade C. Uneventful use of haloperidol and trihehexyphenidyl during three consecutive pregnancies. Arch Womens Ment Health. 2011;14:83-4. PMID: 21116668
9. Uguz F. Breastfed infants exposed to combined antipsychotics: Two case reports. Am J Ther. 2016;23:e1962-4. PMID: 26539905
10. Uguz F. Adverse events in a breastfed infant exposed to risperidone and haloperidol. Breastfeed Med. 2019. 31135176 PMID: 31135176
11. Atmaca M, Kuloglu M, Tezcan E et al. Quetiapine is not associated with increase in prolactin secretion in contrast to haloperidol. Arch Med Res. 2002;33(6):562-5. PMID: 12505103
12. Turkington RW. Prolactin secretion in patients treated with various drugs: phenothiazines, tricyclic antidepressants, reserpine, and methyldopa. Arch Intern Med. 1972;130:349-54. PMID: 4560178
13. Turkington RW. Serum prolactin levels in patients with gynecomastia. J Clin Endocrinol Metab. 1972;34:62-6. PMID: 5061776
14. Fiore L, Scapagnini U, Canonico PL. Effect of dihydroergocryptine and dihydroergocristine on cyclic AMP accumulation and prolactin release in vitro: evidence for a dopaminomimetic action. Horm Res. 1987;25:171-7. PMID: 3032757
15. Crawford AM, Beasley CM Jr, Tollefson GD. The acute and long-term effect of olanzapine compared with placebo and haloperidol on serum prolactin concentrations. Schizophr Res. 1997;26 (1):41-54. PMID: 9376336
16. Langer G, Puhringer W. Haloperidol and droperidol treatment in schizophrenics. Clinical application of the prolactin-model . Acta Psychiatr Belg. 1980;80:574-83. PMID: 7234451
17. Maguire GA. Prolactin elevation with antipsychotic medications: mechanisms of action and clinical consequences. J Clin Psychiatry. 2002;63(suppl 4):56-62. PMID: 11913677
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.