May 22 2022

Classification of the active ingredient albuterol or salbutamol


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

Active substance salbutamol has shown teratogenic effects in laboratory mice at doses equivalent to those commonly used in human clinical practice. The most common deformity in these animals is the crack velopalatal, which were free those mice that were treated with low doses subcutaneously (0.025 mg / kg). Oral administration in a high dose (50 mg / kg) produced a high proportion of cranioschisis.

As with most drugs, there are no adequate studies to assess the teratogenic effect in humans. Published observations of malformations concurrent with taking the drug, failed to establish a causal link between the two.

If indicated, the use of salbutamol during pregnancy should be limited to cases where the potential benefits outweigh the potential risks.

Update 18.07.2009

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.