Clinical trials have proven the safety of NeuroStar TMS Therapy®
in treating depressed patients who've had an inadequate response to prior antidepressant medications.
Treatment with NeuroStar TMS Therapy caused few side effects and was generally well
tolerated by patients. The most common side effects reported during clinical trials were headache and scalp
pain or discomfort — generally mild to moderate and occurring less frequently after
the first week of treatment.
Fewer than 5% of patients discontinued treatment with NeuroStar TMS Therapy due
to adverse events.
Over 10,000 active treatments were performed across all NeuroStar® clinical
trials demonstrating its safety1
- No seizures
- No systemic side effects
- No weight gain
- No sexual dysfunction
- No sedation
- No nausea
- No dry mouth
- No adverse effects on concentration or memory
- No device-drug interactions
There is a low risk of seizure with TMS Therapy. The estimated risk of seizure under ordinary clinical use is approximately 1 in 30,000 treatments (0.003% of treatments) or 1 in 1000 patients (0.1% of patients).
Patients should be carefully monitored for worsening symptoms, signs or symptoms of suicidal behavior and/or unusual behavior. Families and caregivers should also be aware of the need to observe patients and notify their treatment provider if symptoms worsen.
NeuroStar TMS Therapy should not be used (is contraindicated) in patients with implanted metallic
devices or non-removable metallic objects in or around the head. NeuroStar TMS Therapy should
be used with caution in patients with implants controlled by physiological signals. This includes pacemakers
and implantable cardioverter defibrillators (ICDs).
Click here to view full prescribing and safety information
Learn about a typical NeuroStar TMS Therapy treatment session.
References:
- Janicak P, et al. Transcranial Magnetic Stimulation (TMS) in the Treatment of Major
Depression: A Comprehensive Summary of Safety Experience from Acute Exposure, Extended
Exposure and During Reintroduction Treatment. Journal of Clinical Psychiatry,
February 2008.
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