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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.

CYPROTERONE: 784 Adverse Event Reports & Safety Profile

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784
Total FAERS Reports
42 (5.4%)
Deaths Reported
296
Hospitalizations
784
As Primary/Secondary Suspect
47
Life-Threatening
75
Disabilities

Active Ingredient: CYPROTERONE ACETATE ·

First Report: 1982 · Latest Report: 20250701

What Are the Most Common CYPROTERONE Side Effects?

#1 Most Reported
Meningioma
378 reports (48.2%)
#2 Most Reported
Headache
116 reports (14.8%)
#3 Most Reported
Dementia alzheimer's type
96 reports (12.2%)

All CYPROTERONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Meningioma 378 48.2% 6 168
Headache 116 14.8% 0 90
Dementia alzheimer's type 96 12.2% 0 0
Off label use 91 11.6% 5 48
Fatigue 66 8.4% 3 59
Asthenia 53 6.8% 0 50
Paraesthesia 53 6.8% 4 45
Product use in unapproved indication 51 6.5% 7 19
Dizziness 48 6.1% 0 34
Visual impairment 48 6.1% 0 42
Nausea 43 5.5% 2 35
Pain 40 5.1% 3 36
Depression 37 4.7% 3 31
Cognitive disorder 34 4.3% 1 33
Migraine 34 4.3% 0 34
Memory impairment 33 4.2% 2 29
Balance disorder 32 4.1% 1 31
Epilepsy 32 4.1% 1 29
Arthralgia 30 3.8% 0 29
Diplopia 30 3.8% 1 22

Who Reports CYPROTERONE Side Effects? Age & Gender Data

Gender: 75.7% female, 24.3% male. Average age: 46.9 years. Most reports from: FR. View detailed demographics →

Is CYPROTERONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 4 0 4
2002 11 0 10
2004 5 0 4
2005 9 1 6
2007 7 0 7
2008 6 0 4
2009 4 0 3
2010 7 2 2
2011 5 1 1
2012 7 2 4
2013 25 0 16
2014 25 0 21
2015 36 0 26
2016 32 0 10
2017 54 5 34
2018 43 3 30
2019 89 10 15
2020 16 0 1
2021 12 0 2
2022 5 0 1
2023 18 1 6
2024 5 0 0
2025 3 0 3

View full timeline →

What Is CYPROTERONE Used For?

IndicationReports
Prostate cancer 164
Product used for unknown indication 113
Transgender hormonal therapy 85
Hirsutism 64
Hyperandrogenism 29
Acne 27
Antiandrogen therapy 22
Paraphilia 22
Androgenetic alopecia 21
Alopecia 19

CYPROTERONE vs Alternatives: Which Is Safer?

CYPROTERONE vs CYPROTERONE\ETHINYL ESTRADIOL CYPROTERONE vs CYSTEAMINE CYPROTERONE vs CYTARABINE CYPROTERONE vs CYTARABINE\DAUNORUBICIN CYPROTERONE vs DABIGATRAN CYPROTERONE vs DABIGATRAN ETEXILATE CYPROTERONE vs DABRAFENIB CYPROTERONE vs DABRAFENIB\TRAMETINIB CYPROTERONE vs DACARBAZINE CYPROTERONE vs DACLATASVIR

Official FDA Label for CYPROTERONE

Official prescribing information from the FDA-approved drug label.