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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.

SENNA LEAF: 932 Adverse Event Reports & Safety Profile

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932
Total FAERS Reports
169 (18.1%)
Deaths Reported
285
Hospitalizations
932
As Primary/Secondary Suspect
68
Life-Threatening
14
Disabilities
Boiron
Manufacturer

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

First Report: 19950117 · Latest Report: 20250414

What Are the Most Common SENNA LEAF Side Effects?

#1 Most Reported
Asthma
481 reports (51.6%)
#2 Most Reported
Pain
477 reports (51.2%)
#3 Most Reported
Headache
476 reports (51.1%)

All SENNA LEAF Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Asthma 481 51.6% 121 86
Pain 477 51.2% 97 56
Headache 476 51.1% 102 56
Upper respiratory tract infection 440 47.2% 98 48
Hepatic enzyme increased 423 45.4% 103 4
Hyperhidrosis 423 45.4% 103 4
Immunodeficiency 420 45.1% 102 4
Hypersensitivity 419 45.0% 98 4
Food allergy 417 44.7% 101 4
Rash erythematous 393 42.2% 96 1
Rheumatoid arthritis 393 42.2% 97 1
Constipation 392 42.1% 100 65
Fatigue 384 41.2% 101 52
Off label use 382 41.0% 110 43
Drug hypersensitivity 364 39.1% 96 47
Exposure during pregnancy 353 37.9% 91 4
Fluid retention 344 36.9% 102 4
Temperature regulation disorder 340 36.5% 98 4
Back pain 332 35.6% 95 14
Bursitis 323 34.7% 99 1

Who Reports SENNA LEAF Side Effects? Age & Gender Data

Gender: 92.3% female, 7.7% male. Average age: 54.9 years. Most reports from: CA. View detailed demographics →

Is SENNA LEAF Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 1 0 1
2011 2 0 0
2012 1 0 1
2013 1 0 1
2014 9 3 5
2015 19 1 15
2016 12 6 6
2017 13 0 8
2018 9 0 8
2019 10 0 6
2020 19 11 5
2021 9 0 5
2022 8 2 5
2023 5 2 2
2024 1 0 1
2025 4 0 1

View full timeline →

What Is SENNA LEAF Used For?

IndicationReports
Product used for unknown indication 794
Constipation 46
Pain 8
Laxative supportive care 6
Weight decreased 5

SENNA LEAF vs Alternatives: Which Is Safer?

SENNA LEAF vs SENNA LEAF\SENNOSIDES\SENNOSIDES A AND B SENNA LEAF vs SENNOSIDES SENNA LEAF vs SENNOSIDES A AND B SENNA LEAF vs SENSIPAR SENNA LEAF vs SERETIDE SENNA LEAF vs SEROQUEL SENNA LEAF vs SERTRALINE SENNA LEAF vs SETMELANOTIDE SENNA LEAF vs SEVELAMER SENNA LEAF vs SEVOFLURANE

Official FDA Label for SENNA LEAF

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses: See symptoms on front panel. Relieves ketone breath *

Dosage & Administration

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Active Ingredient

SENNA 200CK HPUS Less than 10 -12 mg athraquinone glycosides per pellet Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).

Inactive Ingredients

lactose, sucrose