Germany bans promethazine prescriptions for young children over safety fears

A common sedative just became off-limits for young kids. Regulators warn of hidden risks—and parents need to know their safer alternatives.

, and Administrator

2025 November 22 . 11:01 PM

1 min read

There is a kid standing on the bed, holding one of the railing, with a hand under his chin. He is... — There is a kid standing on the bed, holding one of the railing, with a hand under his chin. He is wearing a blue jacket. Behind him there is a pillow and bed sheets.

Germany bans promethazine prescriptions for young children over safety fears

Germany has introduced a new safety restriction on promethazine, a widely used medication. The drug will no longer be prescribed to children under six due to concerns over serious side effects. This decision follows a review by the country’s drug regulator, the Federal Institute for Drugs and Medical Devices (BfArM).

Promethazine is commonly prescribed as a sedative for agitation and psychiatric disorders. It also serves as an antihistamine for allergic reactions. Despite its long-standing use, the exact way it produces sedative or antipsychotic effects remains unclear. The drug belongs to the phenothiazine class and has anticholinergic, antiemetic, and strong H1-antihistamine properties.

The updated rules aim to reduce avoidable risks in young patients. Doctors and pharmacists will need to adjust prescriptions and inform parents about the change. Alternative treatments with better safety profiles are already available for the same conditions.