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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.

HERBALS: 2,315 Adverse Event Reports & Safety Profile

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2,315
Total FAERS Reports
279 (12.1%)
Deaths Reported
1,105
Hospitalizations
2,315
As Primary/Secondary Suspect
290
Life-Threatening
163
Disabilities

First Report: 1980 · Latest Report: 20250918

What Are the Most Common HERBALS Side Effects?

#1 Most Reported
Off label use
328 reports (14.2%)
#2 Most Reported
Nausea
311 reports (13.4%)
#3 Most Reported
Dyspnoea
239 reports (10.3%)

All HERBALS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 328 14.2% 115 219
Nausea 311 13.4% 93 211
Dyspnoea 239 10.3% 66 104
Constipation 231 10.0% 93 184
Drug ineffective 216 9.3% 60 148
Abdominal pain 214 9.2% 88 162
Pyrexia 198 8.6% 42 164
Vomiting 196 8.5% 86 116
Pain 177 7.7% 25 144
Anaemia 172 7.4% 70 153
Headache 160 6.9% 33 116
Malaise 149 6.4% 8 120
Cough 142 6.1% 13 20
Hyponatraemia 127 5.5% 100 97
Nasopharyngitis 127 5.5% 5 15
Somnolence 127 5.5% 96 83
Erythema 125 5.4% 11 97
Wheezing 124 5.4% 7 15
Muscle spasms 123 5.3% 2 5
Product use in unapproved indication 123 5.3% 52 83

Who Reports HERBALS Side Effects? Age & Gender Data

Gender: 55.5% female, 44.5% male. Average age: 60.2 years. Most reports from: JP. View detailed demographics →

Is HERBALS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 1 0
2001 4 0 4
2004 2 0 0
2005 1 0 0
2006 2 1 2
2007 2 0 2
2009 2 1 1
2010 8 1 8
2011 7 2 6
2012 18 0 15
2013 24 4 14
2014 79 9 45
2015 125 18 62
2016 77 9 50
2017 84 6 32
2018 207 8 65
2019 111 3 55
2020 157 39 75
2021 99 11 54
2022 114 15 58
2023 84 4 42
2024 85 3 42
2025 61 0 25

View full timeline →

What Is HERBALS Used For?

IndicationReports
Product used for unknown indication 911
Constipation 71
Nutritional supplementation 68
Complex regional pain syndrome 35
Pyrexia 29
Covid-19 26
Cough 25
Nasopharyngitis 25
Prophylaxis 24
Upper respiratory tract infection 23

HERBALS vs Alternatives: Which Is Safer?

HERBALS vs HERBALS\MITRAGYNINE HERBALS vs HERBALS\PAULLINIA CUPANA SEED HERBALS vs HERBALS\PLANTAGO INDICA WHOLE HERBALS vs HERBALS\PLANTAGO OVATA LEAF HERBALS vs HERBALS\SAW PALMETTO HERBALS vs HERBALS\SENNA LEAF\SENNOSIDES HERBALS vs HERBALS\SENNOSIDES HERBALS vs HERBALS\TETRAHYDROCANNABINOL UNSPECIFIED HERBALS vs HERBALS\TURMERIC HERBALS vs HERCEPTIN

Official FDA Label for HERBALS

Official prescribing information from the FDA-approved drug label.