Is paliperidone safe to take if I'm pregnant or breastfeeding?

Unborn babies exposed to antipsychotics during the third trimester of pregnancy are at risk for extrapyramidal and withdrawal symptoms after birth. Symptoms reported included agitation, hypertonia, hypotonia, tremor, somnolence, depressed breathing, and feeding disorder. Currently there is no data on the use of paliperidone during pregnancy. Paliperidone should only be used during pregnancy if the potential benefit to the mother outweighs the potential for side effects in the fetus.

A pregnancy exposure registry has been established to monitor the use of atypical antipsychotics, including paliperidone, during pregnancy. All pregnant women treated with atypical antipsychotics are advised to enroll in this pregnancy registry and report any side effects.

Paliperidone is known to enter human milk but its effects on the breastfeeding infant or milk production is not yet known.

What else should I know about paliperidone?

What preparations of paliperidone are available?

Tablets: 1.5, 3, 4, 6, and 9 mg

How should I keep paliperidone stored?

Paliperidone should be stored at room temperature, between 15 C and 30 C (59 F and 86 F).

REFERENCE: FDA Prescribing Information

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