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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.

DUTASTERIDE\TAMSULOSIN: 1,103 Adverse Event Reports & Safety Profile

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1,103
Total FAERS Reports
115 (10.4%)
Deaths Reported
255
Hospitalizations
1,103
As Primary/Secondary Suspect
32
Life-Threatening
14
Disabilities

First Report: 20000910 · Latest Report: 20250301

What Are the Most Common DUTASTERIDE\TAMSULOSIN Side Effects?

#1 Most Reported
Dizziness
101 reports (9.2%)
#2 Most Reported
Hypotension
82 reports (7.4%)
#3 Most Reported
Urinary retention
80 reports (7.3%)

All DUTASTERIDE\TAMSULOSIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dizziness 101 9.2% 3 32
Hypotension 82 7.4% 1 17
Urinary retention 80 7.3% 0 7
Drug ineffective 67 6.1% 1 8
Death 61 5.5% 61 4
Fall 47 4.3% 12 19
Gait disturbance 43 3.9% 0 2
Cerebral hypoperfusion 41 3.7% 0 0
Atrial fibrillation 39 3.5% 0 18
Prostate cancer 38 3.5% 4 5
Speech disorder 38 3.5% 2 2
Constipation 37 3.4% 0 2
Dysphagia 36 3.3% 0 12
Dyspnoea 33 3.0% 0 9
Syncope 33 3.0% 0 15
Condition aggravated 32 2.9% 3 9
Hypomagnesaemia 32 2.9% 0 16
Malaise 32 2.9% 2 11
Feeling cold 30 2.7% 0 0
Acute kidney injury 29 2.6% 23 5

Who Reports DUTASTERIDE\TAMSULOSIN Side Effects? Age & Gender Data

Gender: 1.8% female, 98.2% male. Average age: 73.4 years. Most reports from: BR. View detailed demographics →

Is DUTASTERIDE\TAMSULOSIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2006 4 0 1
2010 5 0 1
2011 1 0 0
2012 4 0 0
2013 27 0 5
2014 71 5 25
2015 88 5 30
2016 41 5 7
2017 43 1 10
2018 56 24 17
2019 44 1 9
2020 31 2 10
2021 47 4 7
2022 25 2 13
2023 19 0 8
2024 28 0 22
2025 3 0 1

View full timeline →

What Is DUTASTERIDE\TAMSULOSIN Used For?

IndicationReports
Product used for unknown indication 526
Benign prostatic hyperplasia 313
Prostatomegaly 83
Prostatic disorder 60
Prostate cancer 10
Dysuria 9
Prostatic specific antigen increased 7
Urinary retention 7

DUTASTERIDE\TAMSULOSIN vs Alternatives: Which Is Safer?

DUTASTERIDE\TAMSULOSIN vs DUVELISIB DUTASTERIDE\TAMSULOSIN vs DYDROGESTERONE DUTASTERIDE\TAMSULOSIN vs EBASTINE DUTASTERIDE\TAMSULOSIN vs ECALLANTIDE DUTASTERIDE\TAMSULOSIN vs ECONAZOLE DUTASTERIDE\TAMSULOSIN vs ECULIZUMAB DUTASTERIDE\TAMSULOSIN vs EDARAVONE DUTASTERIDE\TAMSULOSIN vs EDETATE DUTASTERIDE\TAMSULOSIN vs EDOXABAN DUTASTERIDE\TAMSULOSIN vs EDOXABAN TOSILATE

Official FDA Label for DUTASTERIDE\TAMSULOSIN

Official prescribing information from the FDA-approved drug label.