Safety

Clinical trials have proven the safety of NeuroStar TMS Therapy in depressed treating patients who have 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 effect reported during clinical trials were headache, scalp pain or discomfort — generally mild to moderate and occurring less frequently after the first week of treatment.

Less 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 safety:

TMS therapy patients drinking coffee
  • 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.

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Next see: Is TMS Therapy Right for me?