An encephalopathic syndrome (characterized by weakness, lethargy , fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis , elevated serum enzymes, BUN , and fasting blood sugar) followed by irreversible brain damage has occurred in a few patients treated with lithium plus HALDOL. A causal relationship between these events and the concomitant administration of lithium and HALDOL has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear.
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.