Drug
Saw Palmetto
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Nocturia | 15 | 12.7 | 12.8 | signal |
| 2 | Erectile Dysfunction | 31 | 12.4 | 12.5 | signal |
| 3 | Sexual Dysfunction | 14 | 12.3 | 12.4 | signal |
| 4 | Prostatic Specific Antigen Increased | 15 | 11.1 | 11.2 | signal |
| 5 | Micturition Urgency | 11 | 10.0 | 10.0 | signal |
| 6 | Libido Decreased | 12 | 9.9 | 10.0 | signal |
| 7 | Mitral Valve Incompetence | 9 | 8.2 | 8.2 | signal |
| 8 | Coronary Artery Disease | 24 | 8.1 | 8.2 | signal |
| 9 | Hyperlipidaemia | 9 | 7.7 | 7.7 | signal |
| 10 | Pollakiuria | 31 | 7.6 | 7.7 | signal |
| 11 | Body Height Decreased | 8 | 7.6 | 7.6 | signal |
| 12 | Supraventricular Tachycardia | 7 | 7.5 | 7.5 | signal |
| 13 | Hypotonia | 7 | 7.2 | 7.2 | signal |
| 14 | Incontinence | 7 | 6.8 | 6.8 | signal |
| 15 | Intervertebral Disc Degeneration | 6 | 6.6 | 6.6 | signal |
| 16 | Arteriosclerosis | 6 | 6.5 | 6.5 | signal |
| 17 | Post Procedural Haemorrhage | 7 | 6.1 | 6.2 | signal |
| 18 | Dysuria | 22 | 6.1 | 6.2 | signal |
| 19 | Malignant Melanoma | 8 | 6.1 | 6.1 | signal |
| 20 | Gingival Bleeding | 8 | 6.0 | 6.0 | signal |
| 21 | Flushing | 59 | 5.9 | 6.1 | signal |
| 22 | Coordination Abnormal | 8 | 5.8 | 5.9 | signal |
| 23 | Rotator Cuff Syndrome | 7 | 5.6 | 5.6 | signal |
| 24 | Blood Thyroid Stimulating Hormone Increased | 5 | 5.6 | 5.6 | signal |
| 25 | Atrial Fibrillation | 52 | 5.5 | 5.6 | signal |
| 26 | Squamous Cell Carcinoma | 5 | 5.4 | 5.5 | signal |
| 27 | Coronary Artery Occlusion | 7 | 5.2 | 5.2 | signal |
| 28 | Macular Degeneration | 6 | 5.2 | 5.2 | signal |
| 29 | Musculoskeletal Pain | 26 | 5.0 | 5.1 | signal |
| 30 | Initial Insomnia | 5 | 5.0 | 5.0 | signal |
| 31 | Anorexia | 6 | 4.7 | 4.7 | signal |
| 32 | Multi-organ Failure | 8 | 4.7 | 4.7 | signal |
| 33 | Blood Count Abnormal | 7 | 4.7 | 4.7 | signal |
| 34 | Tooth Fracture | 5 | 4.6 | 4.7 | signal |
| 35 | Local Swelling | 8 | 4.6 | 4.7 | signal |
| 36 | Blood Triglycerides Increased | 8 | 4.6 | 4.6 | signal |
| 37 | Tendonitis | 7 | 4.6 | 4.6 | signal |
| 38 | Jaundice | 12 | 4.6 | 4.6 | signal |
| 39 | Head Injury | 14 | 4.5 | 4.6 | signal |
| 40 | Scab | 5 | 4.5 | 4.5 | signal |
| 41 | Myocardial Ischaemia | 5 | 4.5 | 4.5 | signal |
| 42 | Muscle Tightness | 7 | 4.4 | 4.4 | signal |
| 43 | Subdural Haematoma | 6 | 4.3 | 4.3 | signal |
| 44 | Product Substitution Issue | 24 | 4.3 | 4.3 | signal |
| 45 | Faeces Discoloured | 9 | 4.3 | 4.3 | signal |
| 46 | Glaucoma | 8 | 4.3 | 4.3 | signal |
| 47 | Hospice Care | 4 | 4.2 | 4.2 | signal |
| 48 | Tendon Rupture | 5 | 4.1 | 4.1 | signal |
| 49 | Ageusia | 10 | 4.1 | 4.1 | signal |
| 50 | Brain Injury | 4 | 4.1 | 4.1 | signal |
| 51 | Basal Cell Carcinoma | 6 | 3.9 | 3.9 | signal |
| 52 | International Normalised Ratio Increased | 11 | 3.9 | 3.9 | signal |
| 53 | Middle Insomnia | 7 | 3.9 | 3.9 | signal |
| 54 | Dysgeusia | 28 | 3.8 | 3.9 | signal |
| 55 | Musculoskeletal Disorder | 7 | 3.7 | 3.8 | signal |
| 56 | Cardiac Failure Congestive | 29 | 3.7 | 3.7 | signal |
| 57 | Anger | 12 | 3.6 | 3.6 | signal |
| 58 | Activities Of Daily Living Impaired | 7 | 3.6 | 3.6 | signal |
| 59 | Anosmia | 5 | 3.5 | 3.5 | signal |
| 60 | Haemorrhage Intracranial | 5 | 3.4 | 3.4 | signal |
| 61 | Grand Mal Convulsion | 3 | 3.3 | 3.3 | no signal |
| 62 | Abasia | 8 | 3.3 | 3.3 | signal |
| 63 | Intraocular Pressure Increased | 4 | 3.2 | 3.2 | signal |
| 64 | Abnormal Dreams | 8 | 2.9 | 3.0 | signal |
| 65 | Device Occlusion | 4 | 2.9 | 3.0 | no signal |
| 66 | Myocardial Infarction | 48 | 2.8 | 2.8 | signal |
| 67 | Pharmaceutical Product Complaint | 7 | 2.7 | 2.7 | signal |
| 68 | Drug Administration Error | 8 | 2.6 | 2.6 | signal |
| 69 | Drug Effect Decreased | 14 | 2.6 | 2.6 | signal |
| 70 | Incorrect Drug Administration Duration | 7 | 2.5 | 2.5 | signal |
| 71 | Poisoning | 3 | 2.4 | 2.4 | no signal |
| 72 | Palmar-plantar Erythrodysaesthesia Syndrome | 5 | 2.2 | 2.2 | no signal |
| 73 | Product Quality Issue | 27 | 2.1 | 2.1 | signal |
| 74 | Bone Loss | 3 | 2.0 | 2.0 | no signal |
| 75 | Inappropriate Schedule Of Drug Administration | 14 | 2.0 | 2.0 | no signal |
| 76 | Gynaecomastia | 6 | 2.0 | 2.0 | no signal |
| 77 | Drug Dose Omission | 29 | 1.8 | 1.8 | no signal |
| 78 | Prostate Cancer | 11 | 1.4 | 1.4 | no signal |
| 79 | Application Site Pruritus | 3 | 1.4 | 1.4 | no signal |
| 80 | Incorrect Dose Administered By Device | 3 | 1.2 | 1.2 | no signal |
| 81 | Drug Withdrawal Syndrome | 10 | 1.2 | 1.2 | no signal |
| 82 | Product Adhesion Issue | 3 | 0.9 | 0.9 | no signal |
| 83 | Bladder Cancer | 5 | 0.9 | 0.9 | no signal |