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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.

SAFFLOWER: 82 Adverse Event Reports & Safety Profile

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82
Total FAERS Reports
75 (91.5%)
Deaths Reported
72
Hospitalizations
82
As Primary/Secondary Suspect
66
Life-Threatening
74
Disabilities

First Report: 20181201 · Latest Report: 20250607

What Are the Most Common SAFFLOWER Side Effects?

#1 Most Reported
Somnolence
50 reports (61.0%)
#2 Most Reported
Off label use
49 reports (59.8%)
#3 Most Reported
Hyponatraemia
49 reports (59.8%)

All SAFFLOWER Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Somnolence 50 61.0% 50 42
Condition aggravated 49 59.8% 49 41
Hyponatraemia 49 59.8% 49 41
Off label use 49 59.8% 49 41
General physical health deterioration 48 58.5% 48 40
Stress 48 58.5% 48 40
Multiple organ dysfunction syndrome 46 56.1% 46 38
Anaemia 45 54.9% 45 42
Diabetes mellitus 45 54.9% 45 42
Myasthenia gravis 45 54.9% 45 42
Neuralgia 45 54.9% 45 42
Sepsis 45 54.9% 45 37
Swelling 45 54.9% 45 42
Thrombosis 45 54.9% 45 42
Abdominal distension 43 52.4% 43 36
Bacterial infection 43 52.4% 43 40
Drug hypersensitivity 43 52.4% 43 40
Hypophosphataemia 43 52.4% 43 40
Intentional product misuse 43 52.4% 43 40
Sleep disorder 43 52.4% 43 42

Who Reports SAFFLOWER Side Effects? Age & Gender Data

Gender: 1.1% female, 98.9% male. Average age: 77.6 years. Most reports from: CA. View detailed demographics →

Is SAFFLOWER Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 1 0 0
2020 27 27 25
2021 2 2 1
2025 1 0 1

View full timeline →

What Is SAFFLOWER Used For?

IndicationReports
Constipation 61
Product used for unknown indication 16

Official FDA Label for SAFFLOWER

Official prescribing information from the FDA-approved drug label.