Skip to content
Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

HERBALS\SAW PALMETTO: 528 Adverse Event Reports & Safety Profile

Prostate Health & Male Vitality — Naturally

ProstaVive: better flow, better sleep, better energy. 180-day guarantee.

Learn More
528
Total FAERS Reports
97 (18.4%)
Deaths Reported
317
Hospitalizations
528
As Primary/Secondary Suspect
57
Life-Threatening
10
Disabilities

First Report: 200908 · Latest Report: 20250728

What Are the Most Common HERBALS\SAW PALMETTO Side Effects?

#1 Most Reported
Pruritus
37 reports (7.0%)
#2 Most Reported
Product use issue
35 reports (6.6%)
#3 Most Reported
Off label use
33 reports (6.3%)

All HERBALS\SAW PALMETTO Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pruritus 37 7.0% 7 10
Product use issue 35 6.6% 1 6
Off label use 33 6.3% 11 3
Agranulocytosis 28 5.3% 0 28
Eosinophilia 28 5.3% 8 20
Hepatocellular injury 28 5.3% 0 23
Confusional state 27 5.1% 7 27
Cataract 26 4.9% 0 0
Cholestasis 26 4.9% 7 14
Erectile dysfunction 26 4.9% 0 0
Acne 25 4.7% 0 0
Cerebral haemorrhage 22 4.2% 17 5
Interstitial lung disease 22 4.2% 0 22
Pancreatitis acute 22 4.2% 1 20
Vomiting 21 4.0% 0 21
Rash macular 20 3.8% 0 0
Product use in unapproved indication 19 3.6% 4 15
Coma 18 3.4% 17 1
Acute kidney injury 17 3.2% 1 7
Atrial fibrillation 16 3.0% 0 9

Who Reports HERBALS\SAW PALMETTO Side Effects? Age & Gender Data

Gender: 2.5% female, 97.5% male. Average age: 71.9 years. Most reports from: FR. View detailed demographics →

Is HERBALS\SAW PALMETTO Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 7 7 0
2011 8 0 8
2012 3 1 3
2014 6 0 6
2015 63 1 46
2016 23 1 11
2017 48 0 42
2018 94 25 57
2019 75 28 33
2020 50 3 41
2021 31 2 6
2022 13 0 11
2023 29 10 20
2024 23 14 8
2025 17 0 16

View full timeline →

What Is HERBALS\SAW PALMETTO Used For?

IndicationReports
Benign prostatic hyperplasia 181
Product used for unknown indication 150
Prostatic disorder 30
Micturition disorder 29
Prostatic adenoma 25
Prostate cancer 14
Prostatomegaly 13
Suicide attempt 10
Accidental exposure to product by child 8
Dysuria 8

HERBALS\SAW PALMETTO vs Alternatives: Which Is Safer?

HERBALS\SAW PALMETTO vs HERBALS\SENNA LEAF\SENNOSIDES HERBALS\SAW PALMETTO vs HERBALS\SENNOSIDES HERBALS\SAW PALMETTO vs HERBALS\TETRAHYDROCANNABINOL UNSPECIFIED HERBALS\SAW PALMETTO vs HERBALS\TURMERIC HERBALS\SAW PALMETTO vs HERCEPTIN HERBALS\SAW PALMETTO vs HEROIN HERBALS\SAW PALMETTO vs HETASTARCH HERBALS\SAW PALMETTO vs HISTAMINE HERBALS\SAW PALMETTO vs HISTRELIN HERBALS\SAW PALMETTO vs HIZENTRA

Official FDA Label for HERBALS\SAW PALMETTO

Official prescribing information from the FDA-approved drug label.