Cerebrolysin is not a single peptide. It is a preparation of peptides and amino acids made from pig brain, sold as an injectable solution by EVER Neuro Pharma of Unterach, Austria, and licensed for stroke, brain injury and dementia in a number of European and Asian countries. It has no FDA approval and no US label. On the research-peptide shelf it is sold as if it were one compound, which is the first thing to know about its side-effect record: everything below describes the licensed product given in hospital, by vein or muscle, to patients with brain disease.
The licensed amounts and the registered schedules are on our Cerebrolysin dosage page, and the efficacy record sits on our cognitive peptides page. This page is about harms.
What the maker's own handbook says
With no US label to read, the closest thing to an official adverse-reaction source is the manufacturer. Its 2023 treatment handbook (document CERE/INT/08/2023/17, published on cerebrolysin.com) carries a short safety section, and three things in it are specific:
- Injection speed. "Other minor side effects could be increased heart rate, blood pressure and arrhythmia — related to the speed of administration (this is very common in IV bolous [sic])." The handbook's answer is slower delivery: a 100 mL infusion over 30 to 45 minutes, no longer than an hour.
- Fever. "In rare cases a fever may occur, especially after stroke." The handbook links it to infusion speed and to contamination: "Microbiological contaminants may grow in Cerebrolysin once the ampoule has been opened."
- Interactions. It flags possible additive effects with antidepressants and MAO inhibitors, and states that high doses of MAO inhibitors combined with 30 mL or more of Cerebrolysin "have been reported to increase blood pressure."
The contamination line deserves a second look from anyone buying the research version. The licensed product is a sterile, single-use ampoule, and the maker still treats an opened ampoule as a growth medium. Research-market Cerebrolysin is often sold in multi-draw formats with no stated preservative.
Two different epilepsy rules in one document
The handbook lists contraindications twice, and the two lists differ:
| Where in the handbook | Neurological contraindication | Kidney contraindication |
|---|---|---|
| Section 5, "Special warnings" (page 9) | Status epilepticus | Severe renal failure |
| Prescribing summary (back page) | Epilepsy | Severe renal impairment |
Status epilepticus is a prolonged, continuous seizure emergency; epilepsy is the long-term condition. One document therefore excludes a far larger group than the other. On page 10 the handbook adds that seizures after stroke or brain injury "are not a contra-indication" and that "there is no evidence, that Cerebrolysin causes seizures." Anyone with a seizure history reading only one version will reach a different answer from someone reading the other.
The kidney rule is precise: Cerebrolysin should not be given at KDIGO GFR categories 4 and 5, which is an estimated GFR below 30 mL/min/1.73 m².
The controlled record
Two Cochrane reviews pool the randomised trials.
| Review | Trials, people | Adverse-event finding | Certainty |
|---|---|---|---|
| Acute ischaemic stroke, CD007026.pub7 (2023) | 3 trials, 1,335 | Non-fatal serious adverse events RR 2.39 (1.10 to 5.23); total serious adverse events RR 1.16 (0.81 to 1.66); deaths RR 0.96 | Moderate |
| Vascular dementia, CD008900.pub3 (2019) | 2 trials, 379 | Adverse effects RR 0.91 (0.29 to 2.85) | Very low |
The stroke review's authors call the first finding "a potential increase in non-fatal serious adverse events." Its dose-specific breakdown, which isolates the 30 mL a day for ten days schedule, is set out on the dosage page and is not repeated here. The dementia review describes "no suggestion of adverse effects" but rates the evidence very low and the included trials at high risk of bias.
Three registry trials with posted adverse-event tables
ClinicalTrials.gov held 43 Cerebrolysin registrations on 5 October 2026; three post results with adverse-event tables.
- Vascular dementia, 20 mL vs saline (NCT00947531, sponsor EVER Neuro Pharma). 117 on Cerebrolysin, 115 on saline. Serious adverse events: 3 against 0. No other event reached the trial's 5% reporting threshold in either arm.
- Alzheimer's disease, Cerebrolysin vs donepezil vs both (NCT00911807, sponsor EVER Neuro Pharma). Serious adverse events 1 (Cerebrolysin alone), 1 (combination) and 2 (donepezil alone). The commonest other events in the Cerebrolysin-alone arm were agitation (9), dizziness (6), anorexia, confusional state, insomnia and nasopharyngitis (5 each). The registry posts counts without the number at risk per arm, so rates cannot be computed from it.
- Acute ischaemic stroke, three arms of 20 (NCT02149875, Shanghai 6th People's Hospital). Serious adverse events 7 on Cerebrolysin, 8 on butylphthalide, 11 on placebo; fever 3, 5 and 4; anaemia 4, 5 and 2.
None of the three is large enough to detect an uncommon harm, and two were run by the manufacturer. Together they show what the Cochrane figures show: day-to-day adverse events in Cerebrolysin arms look like those in comparison arms, and serious events are where any signal sits.
FDA's adverse-event database
The openFDA endpoint returned 80 unique reports naming Cerebrolysin on 5 October 2026.
- 71 list it as a concomitant drug only.
- 9 list it as a suspect, and in every one of them other drugs are listed too — most often escitalopram and risperidone.
- Five of the nine carry an identical list of 16 terms (visual hallucination, restlessness, tremor, parkinsonism, mania, Korsakoff's syndrome and others). Identical term lists across reports usually mean one case filed several times as follow-ups, not five patients.
- One suspect report records a death.
- The largest share came from Egypt (22), then Romania (10) and Poland (7), where Cerebrolysin is prescribed; two record the United States as the country of occurrence.
The database cannot tell a reaction to Cerebrolysin from the course of the dementia or the psychiatric drugs it was given with. Why report counts for research-market compounds run so low is covered on our peptide side-effects overview.
What is not established
- Any adverse-event rate in people without stroke, brain injury or dementia, which is where the research market sells it.
- Effects of subcutaneous use, a route that appears in research-market listings and in none of the licensed documents or trials found here.
- Whether a research-market vial labelled Cerebrolysin contains the licensed preparation. It is a mixture rather than a defined molecule, so a purity percentage on a certificate cannot confirm identity; what a certificate can and cannot show is on our how to read a COA page.
- Effects in pregnancy, which the trials excluded.
What Cerebrolysin is and how it is made is covered in Peptide Lexicon's Cerebrolysin entry. Anyone who has used Cerebrolysin and has symptoms — especially a fast or irregular heartbeat, fever or a seizure — should tell a doctor what the vial said and where it came from.
Sources and dates
- EVER Neuro Pharma. Cerebrolysin Treatment Handbook, 2023 (CERE/INT/08/2023/17), cerebrolysin.com — sections 5 (special warnings) and "Handling of specific medical conditions", and the prescribing summary. Read 2026-10-05.
- Ziganshina LE, et al. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2023;10:CD007026.pub7. PMID 37818733.
- Cui S, et al. Cerebrolysin for vascular dementia. Cochrane Database Syst Rev. 2019;11:CD008900.pub3. PMID 31710397 (abstract, adverse-effects finding). Read 2026-10-05.
- ClinicalTrials.gov NCT00947531, NCT00911807 and NCT02149875 — adverse-events modules; registry search "cerebrolysin" (43 studies). Read via API v2, 2026-10-05.
- openFDA drug adverse-event endpoint, medicinal product "cerebrolysin" — all 80 reports retrieved and split by drug characterisation. Run 2026-10-05.
Corrections go to the contact page.