Adverse effect · Cerebrolysin

How common is serious adverse events with Cerebrolysin?

A
Grade A — established in humansCochrane review: 3 RCTs, 1,335 participants · effect size: moderate · adverse
Short answerEstablished in humans. Cochrane review: 3 RCTs, 1,335 participants point the same way: a moderate effect. Non-fatal serious adverse events were more than twice as common on Cerebrolysin, and more so at the higher cumulative dose — moderate-certainty evidence.

What the studies show

Non-fatal serious adverse events were more than twice as common on Cerebrolysin, and more so at the higher cumulative dose — moderate-certainty evidence.

“This comprised fatal SAEs (RR 0.90, 95% CI 0.59 to 1.38; 3 trials, 1335 participants; moderate-certainty evidence) and an increase in the total number of people with non-fatal SAEs (RR 2.39, 95% CI 1.10 to 5.23; 3 trials, 1335 participants; moderate-certainty evidence).”

Verbatim, from the abstractZiganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev, 2023;10:CD007026

Several well-run randomised trials in people, pointing the same way. You can plan around this. It still says nothing about whether the effect is worth the side effects for you.

  1. 1
    Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke.Cochrane Database Syst Rev, 2023;10:CD007026Seven RCTs, 1,773 participants.

In context

Cerebrolysin is a mixture of short peptides and amino acids extracted from pig brain, made in Austria and given as a course of daily intravenous infusions for stroke, dementia and brain injury in Russia, China, Eastern Europe and Asia. It is not approved in the United States, the United Kingdom or EU-wide. The Cochrane review of seven stroke trials found no effect on death and a doubling of non-fatal serious adverse events; the Cochrane review of six vascular-dementia trials found a small cognitive benefit on very low-quality evidence that may be too small to matter.

Cerebrolysin is approved in austria, russia, china and others; not us/uk/eu-wide. Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is Cerebrolysin proven to cause serious adverse events?
Yes, as far as human trials can show it: Cochrane review: 3 RCTs, 1,335 participants. LYO grades this outcome A.
What studies are behind the grade?
Non-fatal serious adverse events were more than twice as common on Cerebrolysin, and more so at the higher cumulative dose — moderate-certainty evidence.
Is Cerebrolysin approved for this?
Cerebrolysin is an approved medicine (Approved in Austria, Russia, China and others; not US/UK/EU-wide); whether this particular outcome is a licensed indication is stated on the compound page's regulation section.

Other outcomes for Cerebrolysin

Written and maintained by LYO Research — how pages are written and checked. Reviewed 10 September 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →