ATOSIBAN for Threatened labour: Side Effects & Safety Data

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There are 25 adverse event reports in the FDA FAERS database where ATOSIBAN was used for Threatened labour.

Most Reported Side Effects for ATOSIBAN

Side Effect	Reports	%	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