Is it safe to use Otrivin (xylometazoline) during pregnancy?

Otrivin (Xylometazoline) Use During Pregnancy

Otrivin (xylometazoline) should be avoided during pregnancy due to insufficient safety data, though short-term use for severe nasal congestion may be considered when benefits clearly outweigh risks, particularly after the first trimester.

Safety Profile and Evidence

The available evidence for xylometazoline use in pregnancy is extremely limited:

• No formal pregnancy safety classification exists for xylometazoline in major obstetric or rheumatology guidelines 1
• Animal studies show potential risks, placing it in the former FDA Category C classification (similar to hydroxyzine, which is recommended to be avoided in pregnancy) 2
• Lack of controlled human studies means the teratogenic potential and fetal effects remain unknown 3, 4

Clinical Considerations

Why Caution is Warranted

• Systemic absorption occurs with nasal decongestants, potentially affecting uterine blood flow through vasoconstriction 3
• First trimester exposure carries highest risk for any medication, as this is the period of organogenesis when congenital malformations are most likely to occur 1
• Most pregnant women overestimate medication risks, but in this case, the lack of safety data justifies caution 5

When Use Might Be Considered

If nasal congestion is severe enough to impact maternal health (inability to sleep, eat, or breathe adequately):

• Limit to second and third trimesters when organogenesis is complete 1
• Use the lowest effective dose for the shortest duration possible 3, 4
• Maximum 3 times daily at 0.025% concentration based on pediatric safety data 6
• Duration should not exceed 3-5 days to prevent rebound congestion and minimize fetal exposure 3

Safer Alternatives

Saline nasal spray (0.9%) is the preferred first-line treatment for nasal congestion in pregnancy:

• No systemic absorption or fetal risk 6, 3
• Can be used unlimited times daily throughout all trimesters 6
• Effective for symptom relief when used frequently 3, 4

Other Options

• Chlorpheniramine has the longest safety record among antihistamines if allergic rhinitis is the cause 2
• Loratadine and cetirizine are former FDA Category B drugs with more favorable safety profiles than xylometazoline 2
• Non-pharmacological measures including humidifiers, nasal strips, and elevation of the head during sleep 3, 4

Common Pitfalls to Avoid

• Do not assume OTC medications are automatically safe - approximately 10% of birth defects are linked to medication exposure during pregnancy 4
• Avoid combination cold medications that may contain multiple active ingredients, increasing exposure risks 3
• Do not use beyond 3-5 days even if symptoms persist, as this increases systemic exposure without additional benefit 3
• Discuss all OTC medication use with your healthcare provider before starting, as individual risk-benefit assessment is essential 3, 4, 7

Bottom Line

Start with saline nasal spray as the safest option 6, 3. If xylometazoline is absolutely necessary due to severe symptoms affecting maternal well-being, use only after the first trimester, at the lowest dose, for the shortest duration (maximum 3-5 days), and only after discussing with your obstetrician 1, 3.