Class | Source | ||
TGA* | ERS/TSANZ task force | ||
| Short-acting beta2 agonists | Overall | – | Unlikely to cause structural anomalies Avoid excessive use |
| Salbutamol | Category A | Compatible (all) | |
| Terbutaline | Category A | Probably safe (all) | |
| Long-acting beta2 agonists | Overall | – | Limited data from humans and animals suggest no risk or low risk salmeterol and formoterol |
| Formoterol | Category B3 | Probably safe (all) Acceptable to continue if symptoms were already controlled with formoterol treatment before conception | |
| Indacaterol | Category B3 | – | |
| Salmeterol | Category B3 Benefits outweigh risk | Probably safe (all) Greater experience of use in pregnancy | |
| Vilanterol | Category B3 | – | |
| Long-acting muscarinic antagonists | Glycopyrronium | Category B2 | – |
| Tiotropium | Category B1 | Compatible (breastfeeding) Probably safe (pregnancy and labour) | |
| Umeclidinium | Category B1 | – | |
| Inhaled corticosteroids | Overall | – | At usual doses, ICSs have not been associated with increased risk of major malformations, intrauterine growth restriction, pre-term delivery or low birthweight Use lowest dose necessary to maintain asthma control Greater volume of pregnancy safety data available for budesonide and beclometasone Any ICS can be continued if asthma was controlled during treatment before conception |
| Beclometasone | Category B3 Benefits outweigh risk | Compatible (all) Beclometasone >1000 microg/day associated with a small risk of congenital malformation in one study | |
| Budesonide | Category A Benefits outweigh risk | Compatible (all) | |
| Fluticasone furoate | Category B3 Benefits outweigh risk | ||
| Ciclesonide | Category B3 | Probably safe (all) | |
| Fluticasone propionate | Category B3 Benefits outweigh risk | Compatible (all) | |
| Mometasone furoate | – | Probably safe (all) | |
| Monoclonal antibody therapy | Overall | – | Very limited evidence |
| Benralizumab | Category B1 | Possibly safe (all) | |
| Dupilumab | Category B1 | Possibly safe (all) | |
| Mepolizumab | Category B1 | Possibly safe (all) | |
| Omalizumab | Category B1 | Probably safe (pregnancy) Possibly safe (labour and breastfeeding) | |
| Leukotriene receptor antagonists | Montelukast | Category B1 | Probably safe (all) |
| Systemic corticosteroids | Prednisolone/prednisone | Category A | Possibly safe (all) Conflicting safety data |
| Intranasal corticosteroids | – | As for inhaled formulations with same molecule | Compatible (breastfeeding) Probably safe (pregnancy and labour) |
| Allergen immunotherapy | – | – | Recommendation against initiating allergen immunotherapy during pregnancy Can be continued during pregnancy if well tolerated before pregnancy |
Additional information
TGA: TGA. Prescribing medicines in pregnancy database. The Australian categorisation system and database for prescribing medicines in pregnancy. [Website] [Accessed February 2025] Australian Government Department of Health and Aged Care Therapeutic Goods Administration.
ERS/TSANZ task force: Middleton PG, Gade EJ, Aguilera C, et al. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J 2020; 55: 1901208.
* Check latest assessment on the TGA database of medicines rated under the Australian categorisation system for prescribing medicines in pregnancy
Category A: Australian categorisation system for prescribing medicines in pregnancy assessment: ‘Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.’ [TGA]
Category B: Australian categorisation system for prescribing medicines in pregnancy assessment: ‘Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.’ [TGA]
Category B3: Australian categorisation system for prescribing medicines in pregnancy assessment: ‘Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.’ [TGA]
Benefits outweigh risk: TGA statement ‘The benefits of asthma control outweigh any potential for an adverse pregnancy outcome’ applies. [TGA]
Compatible (all): ERS/TSANZ task force judgment ‘compatible with all stages of pregnancy, labour, and breastfeeding’. In general, a first-choice option; sufficient anecdotal evidence of very low or non-existent risk to embryo or foetus, based on use during human pregnancies. [Middleton 2020]
Compatible (specified): ERS/TSANZ task force judgment ‘compatible with’ specified stage (pregnancy, labour, or breastfeeding) [Middleton 2020]
Probably safe (all): ERS/TSANZ task force judgment ‘probably safe throughout all stages of pregnancy, labour, and breastfeeding’. In general, characteristics of the medicine or medicines in the same class suggest low risk, but limited trial experience during human pregnancy or breastfeeding. [Middleton 2020]
Probably safe (specified): ERS/TSANZ task force judgment ‘probably safe’ during specified stage [Middleton 2020]
Possibly safe (all): ERS/TSANZ task force judgment ‘possibly safe during all stages of pregnancy, labour, and breastfeeding.’ Considered for second-line use if better-tested treatment options fail. Direct maternal benefit is thought likely to outweigh potential risk during pregnancy and/or breastfeeding, but exact risks are unknown. [Middleton 2020]
Possibly safe (specified): ERS/TSANZ task force judgment ‘possibly safe’ during specified stage. [Middleton 2020]