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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.

SAW PALMETTO: 37 Adverse Event Reports & Safety Profile

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37
Total FAERS Reports
4 (10.8%)
Deaths Reported
19
Hospitalizations
37
As Primary/Secondary Suspect
3
Life-Threatening
3
Disabilities
Boiron
Manufacturer

Route: ORAL · Manufacturer: Boiron · HUMAN OTC DRUG · FDA Label: Available

First Report: 2001 · Latest Report: 20170112

What Are the Most Common SAW PALMETTO Side Effects?

#1 Most Reported
Cholestasis
4 reports (10.8%)
#2 Most Reported
Rectal haemorrhage
3 reports (8.1%)
#3 Most Reported
Interstitial lung disease
3 reports (8.1%)

All SAW PALMETTO Side Effects by Frequency

No side effect data available.

Who Reports SAW PALMETTO Side Effects? Age & Gender Data

Gender: 7.9% female, 92.1% male. Average age: 73.6 years. Most reports from: FR. View detailed demographics →

Is SAW PALMETTO Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2009 3 2 1
2012 1 1 1
2014 7 0 6
2015 9 0 4
2016 7 0 4
2017 2 0 2

View full timeline →

What Is SAW PALMETTO Used For?

IndicationReports
Product used for unknown indication 9
Benign prostatic hyperplasia 8

Official FDA Label for SAW PALMETTO

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

INDICATIONS Condition listed above or as directed by the physician

Dosage & Administration

DOSAGE Adults: Mix 4-6 drops in 1/2 cup of water, take orally three times daily or as directed by a physician. Children (2 years and older): Take half the adult dose.

Warnings

WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use.

Active Ingredient

Sabal serrulata 200CK (**contains 0.443 mg of the active ingredient per pellet)

Inactive Ingredients

INACTIVE INGREDIENTS Active: As Above; Inactive: ENA 50% v/v and Purified Water q.s.