Favourable Safety Profile
Real-world evidence from over 30,000 users confirms a low incidence of adverse reactions1.
Contraindications
No universal contraindications.
Warnings and Precautions
- Broken/inflamed/infected skin (including, for example, psoriasis) at the electrode site
- Cranial or intracranial implant (e.g. brain clips, deep brain stimulators)
- Craniofacial abnormalities (e.g., congenital deformities, severe trauma, or reconstructive surgeries) which may affect electrode placement
- Epilepsy or history of seizures
- Active suicidal ideation (requires closer monitoring)
- History of hypomania or mania (may require closer monitoring)
Special populations
Other chronic conditions: No known interactions with medications; used by individuals with diabetes, heart disease, hypertension, asthma, co-occurring mental health conditions, neurodivergence, and brain injuries/ disorders without reported safety concerns.
Pregnancy: Not licensed for use; no safety concerns identified in existing studies, research ongoing.
Breastfeeding: Safe to use; no effect on breast milk production.
Postpartum: Appears safe for postpartum depression and successfully used in NHS pilots.
Children and Adolescents: Not licensed for use; studies ongoing for ages 14+
Adverse reactions
Evidence breakdown shown is based on real-world data collected from 28,000 users until June 2024. Please note percentages may vary slightly with time because of the constantly growing number of patients.
Adverse events should be reported. Report forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Flow Neuroscience by emailing support@flowneuroscience.com.
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Reference:
Data on file. Flow Neuroscience Real-world reports.