Is Omnaris (ciclesonide) safe to use during pregnancy?

Is Omnaris (Ciclesonide) Safe in Pregnancy?

Omnaris (ciclesonide) has no available safety data for use during pregnancy, but other intranasal corticosteroids with established safety profiles should be preferred. 1

Intranasal Corticosteroid Safety in Pregnancy

Preferred Options with Safety Data

• Budesonide is the preferred intranasal corticosteroid during pregnancy as it carries an FDA Pregnancy Category B designation based on extensive human safety data. 2

• Beclomethasone, fluticasone propionate, and mometasone have accumulated reassuring safety data showing no increased risk of major malformations, preterm delivery, low birth weight, or pregnancy-induced hypertension in meta-analyses. 2

• If a patient is already well-controlled on any intranasal corticosteroid before pregnancy, it is reasonable to continue that medication rather than switching, as no substantial differences in efficacy or safety have been demonstrated among available agents. 2

Ciclesonide-Specific Evidence Gap

• Data about the safety of intranasal ciclesonide (Omnaris) during pregnancy are not available. 1

• For medications with insufficient pregnancy safety data, the risk-benefit ratio must be carefully considered before prescribing, though lack of evidence does not necessarily indicate risk. 3

Clinical Decision Algorithm

When managing rhinitis in pregnancy:

1. If starting intranasal corticosteroid therapy during pregnancy, choose budesonide as the first-line agent due to its Category B status and extensive human data. 2

2. If the patient is already using Omnaris with good disease control before pregnancy, consider switching to budesonide, beclomethasone, fluticasone propionate, or mometasone given the lack of safety data for ciclesonide. 2, 1

3. Administer intranasal corticosteroids at the lowest effective dose when used during pregnancy. 2

4. Untreated rhinitis can affect maternal quality of life, so treatment should not be withheld when clinically indicated—simply choose agents with established safety profiles. 2

Important Caveats

• Most intranasal corticosteroids carry FDA Pregnancy Category C ratings, but observational human data have been reassuring and have not confirmed gestational risk. 2

• The majority of medications used during pregnancy lack adequate safety data, with 97.7% of drugs approved between 2000-2010 having "undetermined" teratogenic risk. 4

• Pregnant women should not be denied necessary treatment due to lack of data alone, but when alternatives with established safety exist, they should be prioritized. 3