Favourable safety profile
Real-world evidence from over 30,000 users confirms a low incidence of adverse reactions1.
Contraindications
No universal contraindications.
Warning 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.
Note : 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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[1] Data on file. Flow Neuroscience Real-world reports.