Tesofensine: Side Effects & Safety

Part of the Tesofensine Complete Guide

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Overall Safety Profile

Tesofensine's cardiovascular effects — elevated heart rate and blood pressure — have been the primary barrier to regulatory approval. The FDA and EMA have required additional cardiovascular safety data before approving monoamine reuptake inhibitors for obesity following historical concerns with similar mechanisms.

Reported Side Effects

  • Elevated heart rate: Mean +7–8 bpm at therapeutic doses
  • Dry mouth: Very common (noradrenergic effect)
  • Insomnia: Due to dopamine and norepinephrine elevation
  • Constipation: Serotonergic effect
  • Mood changes: Anxiety, irritability in some participants
  • Blood pressure: Modest increases

Important Limitations

Long-term cardiovascular safety data is absent. The monoamine mechanism raises concerns about abuse potential (dopamine), serotonin syndrome (drug interactions), and cardiovascular events with prolonged use. Not FDA-approved.

Contraindications

  • Uncontrolled hypertension or cardiovascular disease
  • History of stroke or MI
  • Concurrent use of MAOIs or SSRIs (serotonin syndrome risk)
  • Anxiety disorders (may worsen symptoms)
  • Pregnancy and breastfeeding

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Peptides Insider Editorial Team

Our content is reviewed for accuracy and grounded in peer-reviewed research where available. We do not provide medical advice. Always consult a qualified healthcare professional.