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Epidemiological data suggest that there may be an association between the use of carbamazepine during pregnancy and congenital malformationsincluding spina bifidaThere have also been reports that associate carbamazepine with developmental disorders and congenital anomaliese.gcraniofacial defectscardiovascular malformationsand anomalies involving various body systemsDevelopmental delays based on neurobehavioral assessments have been reportedWhen treating or counseling women of childbearing potentialthe prescribing physician will wish to weigh the benefits of therapy against the risksIf this drug is used during pregnancyor if the patient becomes pregnant while taking this drugthe patient should be apprised of the potential hazard to the fetus.

Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnantThis registry is collecting information about the safety of antiepileptic drugs during pregnancyTo enrollpatients can call the toll free number 1-888-233-2334see WARNINGSUsage in Pregnancy subsection

Oral LD50 in animalsmg/kgmice1100 to 3750rats3850 to 4025rabbits1500 to 2680guinea pigs920.

Urinary frequencyacute urinary retentionoliguria with elevated blood pressureazotemiarenal failureand impotenceAlbuminuriaglycosuriaelevated BUNand microscopic deposits in the urine have also been reportedThere have been rare reports of impaired male fertility and/or abnormal spermatogenesis.

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