Toxicity Data: Oral TDLO (child): 4167 ?g/kg; Oral TDLO (man): 714 ?g/kg/1D (intermittent); Oral TDLO (woman): 10 mg/kg ^F3454.

Ingestion of 750 mg or more by an adult may result in severe toxicity. The effects in overdose are further increased by simultaneous ingestion of alcohol and another psychotropic agent ^{FDA label}. Symptoms of overdose include abnormally low blood pressure, confusion, convulsions, dilated pupils and other eye problems, disturbed concentration, drowsiness, hallucinations, impaired heart function, rapid or irregular heartbeat, reduced body temperature, stupor, and unresponsiveness or coma, among others ^{FDA label}, ^F3454.

Use in pregnancy

For amitriptyline, only limited clinical data are available regarding its use in pregnancy.
Amitriptyline is not recommended during pregnancy unless clearly required and only after careful consideration of both risks and benefits ^{FDA label}.

Use in breastfeeding

Amitriptyline and its metabolites are excreted into breast milk (corresponding to 0.6 % - 1 % of the maternal dose). A risk to the suckling child must be considered. A decision should be made as to whether it is appropriate to discontinue breastfeeding or to discontinue/abstain from the therapy of this medicinal product, considering the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Effects on fertility

Animal studies have shown reproductive toxicity. No data on the effects of amitriptyline on human fertility are available ^{FDA label}.

Mutagenesis and carcinogenesis

The genotoxic potential of amitriptyline has been investigated in various in vitro and in vivo studies. Although these investigations showed
some contradictory results, a potential of amitriptyline to lead to chromosome abnormalities cannot be excluded. Long-term carcinogenicity studies have not been performed to this date ^{FDA label}.