Atosiban: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 1, 2026🚩 Report this page

Atosiban

Other Gynecologicals

Sold as Tractocile

GB MHRAEU EMA

Drug class: Other Gynecologicals
Availability: See label
Markets covered: 2
Products on record: 9

Overview

Atosiban is an active pharmaceutical ingredient in the Other Gynecologicals group (G02CX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	7	May 1, 2026
EU European Union	EMA	2	June 20, 2024

GBUnited Kingdom· MHRA

7 products

Uses

GBOfficial regulatory label· revised January 9, 2026[1]

Atosiban accord injection is indicated to delay imminent pre-term birth in pregnant adult women with: - regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes - a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50% - a gestational age from 24 until 33 completed weeks - a normal foetal heart rate

How to take

EUEuropean Union· EMA

2 products

Uses

EUOfficial regulatory label· revised June 20, 2024[2]

Atosiban is indicated to delay imminent pre-term birth in pregnant adult women with: - regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes - a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50% - a gestational age from 24 until 33 completed weeks - a normal foetal heart rate

How to take

Sources & citations

[1]MHRA (UK) · PL200750398 · revised January 9, 2026
[2]European Medicines Agency · EMEA/H/C/002329 · revised June 20, 2024

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised January 9, 2026[1]

Possible adverse reactions of atosiban were described for the mother during the use of atosiban in clinical trials. In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials. The observed adverse reactions were generally of a mild severity.
The most commonly reported adverse reaction in the mother is nausea (14 %). For the newborn, the clinical trials did not reveal any specific adverse reactions of atosiban. The infant adverse reactions were in the range of normal variation and were comparable with both placebo and betamimetic group incidences.
The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
MedDRA System Organ Class (SOC) Very common Common Uncommon Rare Immune system disorders Allergic reaction Metabolism and nutrition disorders Hyperglycaemia Psychiatric disorder Insomnia Nervous system disorders Headache, Dizziness Cardiac disorders Tachycardia Vascular disorders Hypotension, Hot flush Gastrointestinal disorders Nausea Vomiting Skin and subcutaneous tissue disorders Pruritis, Rash Reproductive system and breast disorder Uterine haemorrhage, uterine atony General disorders and administration site conditions Injection site reaction Pyrexia Post-marketing experience Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other medicinal products with tocolytic activity, like calcium antagonists and betamimetics, and/or in women with multiple pregnancy, have been reported post-marketing.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

GBOfficial regulatory label· Warnings and precautions· revised January 9, 2026[1]

When atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits of delaying delivery should be balanced against the potential risk of chorioamnionitis. There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys.
Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine. 2). There is only limited clinical experience in the use of atosiban in multiple pregnancies or the gestational age group between 24 and 27 weeks, because of the small number of patients treated.
The benefit of atosiban in these subgroups is therefore uncertain. 2). In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of Atosiban accord injection depends on the assessment of fetal maturity.
Monitoring of uterine contractions and fetal heart rate during administration of atosiban and in case of persistent uterine contractions should be considered. As an antagonist of oxytocin, atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored.
However, inadequate uterus contraction postpartum was not observed during the clinical trials. Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and betamimetics are known to be associated with increased risk of pulmonary oedema.
8).

This is not medical advice. Consult a qualified healthcare professional.