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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.

UROFOLLITROPIN: 101 Adverse Event Reports & Safety Profile

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101
Total FAERS Reports
1 (1.0%)
Deaths Reported
84
Hospitalizations
101
As Primary/Secondary Suspect
1
Disabilities
Discontinued
Status

FDA Application: 019415 ·

First Report: 19980210 · Latest Report: 20250731

What Are the Most Common UROFOLLITROPIN Side Effects?

#1 Most Reported
Ovarian hyperstimulation syndrome
73 reports (72.3%)
#2 Most Reported
Abdominal distension
25 reports (24.8%)
#3 Most Reported
Abdominal pain
20 reports (19.8%)

All UROFOLLITROPIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Ovarian hyperstimulation syndrome 73 72.3% 1 66
Abdominal distension 25 24.8% 0 21
Abdominal pain 20 19.8% 0 16
Ascites 13 12.9% 0 13
Nausea 12 11.9% 0 11
Chest discomfort 10 9.9% 0 8
Dyspnoea 10 9.9% 0 10
Vomiting 10 9.9% 0 8
Oliguria 7 6.9% 0 7
Off label use 5 5.0% 0 4
Pelvic fluid collection 5 5.0% 0 5

Who Reports UROFOLLITROPIN Side Effects? Age & Gender Data

Gender: 97.6% female, 2.4% male. Average age: 32.6 years. Most reports from: CN. View detailed demographics →

Is UROFOLLITROPIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 6 0 6
2015 4 0 4
2016 8 0 8
2017 2 0 2
2019 1 0 0
2021 4 0 4
2022 9 0 9
2023 18 0 15
2024 12 0 10
2025 8 0 8

View full timeline →

What Is UROFOLLITROPIN Used For?

IndicationReports
Ovulation induction 37
In vitro fertilisation 26
Assisted reproductive technology 7
Product used for unknown indication 7
Infertility 6

UROFOLLITROPIN vs Alternatives: Which Is Safer?

UROFOLLITROPIN vs URSODIOL UROFOLLITROPIN vs USTEKINUMAB UROFOLLITROPIN vs USTEKINUMAB-STBA UROFOLLITROPIN vs VADADUSTAT UROFOLLITROPIN vs VALACYCLOVIR UROFOLLITROPIN vs VALBENAZINE UROFOLLITROPIN vs VALBENAZINE DITOSYLATE UROFOLLITROPIN vs VALDECOXIB UROFOLLITROPIN vs VALERIAN UROFOLLITROPIN vs VALGANCICLOVIR

Official FDA Label for UROFOLLITROPIN

Official prescribing information from the FDA-approved drug label.