May 23 2022

Classification of the active ingredient amphetamine


Risk level in pregnancy: This medicine is classified as Category C.

The dextro isomer of amphetamine not seem to have effects on embryonic and fetal morphology in rats at oral doses up to 16 mg / kg in the phase of organogenesis. However, observations on fetal malformations have been published when administered parenterally in high doses. These doses also resulted in toxicity in pregnant animals.

At usual doses in human clinical, laboratory animals exposed during gestation or shortly after, may suffer alteration of functions such as memory impairment or learning, motor disturbances and sexual behavior.

Infants exposed in utero to amphetamines have an increased risk of prematurity and low birth weight. Occasionally may have a withdrawal syndrome with agitation, laxity and dysphoria.

The use of dextroamphetamine in pregnant women is justified only if the potential benefits were clearly superior to the potential hazards of the substance.

Update 10.12.2010

Meaning of category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.