Background
In 2014, a composite pack containing mifepristone‐buccal misoprostol, indicated for use to 63 days gestation replaced the existing regimen for early medical abortion (EMA) in Australia.

Aims
To provide updated efficacy and safety information for the use of mifepristone–buccal misoprostol for EMA in Australia, and assess the effect of patient age and gestational age on efficacy.

Materials and methods
Observational cohort study of 15 008 women attending one of 16 Marie Stopes International clinics in Australia for an EMA (gestational age ≤ 63 days) between 1 March 2013 and 30 September 2015. Administration of 200 mg oral mifepristone in‐clinic was followed 24–48 h later by 800 μg buccal misoprostol self‐administered at home. Method success was defined as complete abortion not requiring surgical intervention.

Results
Follow‐up information was available for 87.14% (13 078/15 008) of women. Likelihood of follow‐up was significantly lower for women from rural or remote locations (adjusted odds ratio, 0.47; P < 0.001). Medical abortion was successful in 95.16% (12 445/13 078) of women with follow‐up. Higher patient and gestational ages were associated (P < 0.001) with a slight increase in method failure. There were 674 serious adverse events (5.15%), mainly due to method failure. Infection (15; 0.11%) and haemorrhage (17; 0.13%) were rare. One death was recorded (<0.01%); however, an association between EMA and cause of death, necrotising pneumonia, was not established. Conclusion Mifepristone–buccal misoprostol is an effective and safe alternative to surgical termination of pregnancy up to 63 days gestation.