Is salinase (generic name) safe for use in infants under 1 year of age?

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Last updated: January 5, 2026View editorial policy

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Safety of Saline Nasal Solutions in Infants

Saline nasal irrigation and spray are safe for use in infants under 1 year of age, with evidence supporting their use for nasal congestion and upper respiratory symptoms starting at 3 months of age. 1

Evidence for Safety

The safety profile of saline nasal solutions in infants is well-established:

  • A systematic review of randomized controlled trials (569 participants) found saline nasal irrigation to be a safe treatment in infants ≥3 months and children ≤12 years. 1 No significant adverse events were reported across the included studies.

  • In hospitalized infants under 2 years, saline-only nasal treatment (0.9% concentration, unlimited frequency) demonstrated a favorable safety profile. 2 The incidence of adverse events was actually lower when compared to baseline expectations, with no life-threatening events identified.

  • Saline nasal irrigation provides clinical benefit for rhinological symptoms (nasal congestion, discharge) with a statistically significant improvement (SMD = -0.29 [-0.45; -0.13]). 1 This supports both efficacy and safety when used for its intended purpose.

Clinical Application

Appropriate Use

  • Saline solutions can be administered via spray, drops, or irrigation in infants starting at 3 months of age. 1
  • The concentration should be isotonic (0.9% saline) and can be used with unlimited frequency as needed. 2
  • Long-term use has been shown to decrease the incidence of acute rhinosinusitis and its complications, further supporting its safety profile. 1

Additional Benefits

  • Saline nasal irrigation reduces the need for other medications, including antibiotics, making it a safe first-line approach for nasal congestion. 1
  • The treatment helps remove debris from the nasal cavity and temporarily reduces tissue edema to promote drainage. 3

Important Caveats

Saline nasal spray differs from saline nasal irrigation/lavage in terms of delivery method and volume, though both are considered safe. 3 The evidence base is stronger for irrigation than for simple spray application, but both modalities are used safely in clinical practice.

While generally safe across all infant age groups, the strongest evidence supports use in infants ≥3 months of age. 1 For younger infants, clinical judgment should guide use, though no specific safety concerns have been identified.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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