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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.

ATOSIBAN: 601 Adverse Event Reports & Safety Profile

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601
Total FAERS Reports
18 (3.0%)
Deaths Reported
108
Hospitalizations
601
As Primary/Secondary Suspect
20
Life-Threatening

First Report: 20100501 · Latest Report: 20241205

What Are the Most Common ATOSIBAN Side Effects?

#1 Most Reported
Maternal exposure during pregnancy
299 reports (49.8%)
#2 Most Reported
Premature baby
246 reports (40.9%)
#3 Most Reported
Premature delivery
232 reports (38.6%)

All ATOSIBAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Maternal exposure during pregnancy 299 49.8% 2 26
Premature baby 246 40.9% 12 43
Premature delivery 232 38.6% 0 10
Foetal exposure during pregnancy 219 36.4% 15 47
Product use in unapproved indication 177 29.5% 0 1
Delivery 123 20.5% 0 0
Normal labour 123 20.5% 0 0
Low birth weight baby 52 8.7% 4 27
Exposure during pregnancy 50 8.3% 1 18
Acute pulmonary oedema 22 3.7% 0 15
Drug ineffective 22 3.7% 4 5
Off label use 16 2.7% 3 7
Neonatal respiratory distress syndrome 15 2.5% 0 9
Condition aggravated 14 2.3% 6 5
Dyspnoea 13 2.2% 0 10
Inguinal hernia 13 2.2% 0 13
Pleural effusion 13 2.2% 0 12
Anaemia 12 2.0% 0 10
Foetal distress syndrome 12 2.0% 0 9
Hyperbilirubinaemia 12 2.0% 0 11

Who Reports ATOSIBAN Side Effects? Age & Gender Data

Gender: 92.2% female, 7.8% male. Average age: 31.5 years. Most reports from: CA. View detailed demographics →

Is ATOSIBAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 4 1 2
2011 4 0 3
2012 1 0 0
2015 4 0 2
2016 2 0 2
2017 9 0 8
2018 3 0 1
2019 1 0 0
2020 8 0 1
2021 2 0 2
2022 3 0 3
2023 8 0 0
2024 1 0 1

View full timeline →

What Is ATOSIBAN Used For?

IndicationReports
Product used for unknown indication 236
Foetal exposure during pregnancy 117
Tocolysis 70
Threatened labour 25
Uterine contractions during pregnancy 17
Premature labour 14
Prophylaxis 7
Exposure during pregnancy 6
Premature delivery 5

ATOSIBAN vs Alternatives: Which Is Safer?

ATOSIBAN vs ATOVAQUONE ATOSIBAN vs ATOVAQUONE\PROGUANIL ATOSIBAN vs ATRACURIUM ATOSIBAN vs ATRIPLA ATOSIBAN vs ATROPINE ATOSIBAN vs ATROPINE\ATROPINE ATOSIBAN vs ATROPINE\DIPHENOXYLATE ATOSIBAN vs AUBAGIO ATOSIBAN vs AUGMENTIN ATOSIBAN vs AUTOLOGOUS CULTURED CHONDROCYTES

Official FDA Label for ATOSIBAN

Official prescribing information from the FDA-approved drug label.