Cerebrolysin: Side Effects & Safety

Cerebrolysin has been used clinically since the 1970s with a generally favorable safety profile established across multiple clinical trials. Serious adverse events are rare. The most common side effects are injection-related and typically mild.

• Injection site pain: Most common — particularly with IM injection
• Dizziness: Usually transient
• Headache: Mild, occasional
• Nausea: Uncommon
• Agitation: Rare, more common in dementia patients
• Allergic reactions: Rare, possible given porcine origin

Not FDA-approved. Despite extensive use in 50+ countries, the FDA has required additional large-scale trials meeting Western regulatory standards. Porcine-derived origin raises theoretical prion disease concerns, though no cases have been reported. Some meta-analyses have questioned the quality of individual trials.

• Severe renal impairment
• Epilepsy (may lower seizure threshold)
• Known allergy to porcine products
• Allergic diathesis
• Pregnancy and breastfeeding