Adverse Event Profile: Saw Palmetto

Source: FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System Total Events: 16 Serious Events: 11 Date Range: 20040402 to 20231128

Top Reported Reactions

  • HOSPITALISATION: 2
  • Blood folate increased: 1
  • Disturbance in attention: 1
  • Mania: 1
  • Bradycardia: 1
  • Nausea: 1
  • Vomiting: 1
  • CHOKING SENSATION: 1
  • COUGH: 1
  • DYSPHONIA: 1
  • DYSPNOEA: 1
  • PROSTATIC SPECIFIC ANTIGEN ABNORMAL: 1
  • UROLOGICAL EXAMINATION: 1
  • Brain stem haemorrhage: 1
  • Cerebrovascular accident: 1
  • Death: 1
  • Pulmonary embolism: 1
  • Abdominal pain: 1
  • Prostate cancer: 1
  • Prostatic specific antigen increased: 1

Outcomes

  • Other Serious or Important Medical Event: 7
  • Hospitalization: 6
  • Visited a Health Care Provider: 4
  • Life Threatening: 2
  • Disability: 2
  • Other Serious Outcome: 2
  • Other Outcome: 1
  • Visited Emergency Room: 1
  • Death: 1

Products Involved (11 unique)

  • MEGA MEN ENERGY VITAPAK PROGRAM SAW PALMETTO FORMU
  • NATURE'S BOUNTY SAW PALMETTO
  • NATURES BOUNTY SAW PALMETTO
  • PURITAN'S PRIDE FLOW GUARD SAW PALMETTO
  • PURITAN'S PRIDE SAW PALMETTO EXTRACT
  • PURITANS PRIDE EXTRA STRENGTH PROSTA-METTO SAW PAL
  • PURITANS PRIDE PROSTA-METTO SAW PALMETTO COMPLEX
  • SAW PALMETTO
  • SAW PALMETTOS
  • SWANSON WHOLE HERB SAW PALMETTO PROSTRATE HEALTH
  • Saw Palmetto

Disclaimer

This data is from the FDA CAERS database. A report does not mean the supplement caused the adverse event. Reports may be incomplete, duplicated, or unrelated. This is for safety awareness only.