No black box warning on record for Baclofen

As of the latest FDA labeling reviewed, Baclofen (BACLOFEN) does not carry a black box warning. Standard warnings and precautions still apply — see the full Baclofen medicine page for the complete safety profile.

Other warnings & precautions

WARNINGS a. Neonatal Withdrawal Symptoms: Withdrawal symptoms have been reported starting hours to days after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and oral baclofen i

No black box warning on record for Baclofen

Other warnings & precautions

WARNINGS a. Neonatal Withdrawal Symptoms: Withdrawal symptoms have been reported starting hours to days after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and oral baclofen i

Baclofen Black Box Warning

No black box warning on record for Baclofen

Other warnings & precautions

Baclofen Black Box Warning

No black box warning on record for Baclofen

Other warnings & precautions