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Use of xylometazoline in hospitalised infants: is it safe? A retrospective cohort study
  1. Karlijn J van Stralen1,
  2. Joyce E van Tol1,2,
  3. Saskia N de Wildt3,4,
  4. Matthijs L Becker5,6,
  5. Marlies A van Houten1,2
  1. 1 Spaarne Gasthuis Academy, Spaarne Gasthuis Hospital, Haarlem, The Netherlands
  2. 2 Department of Pediatrics, Spaarne Gasthuis Hospital, Haarlem, The Netherlands
  3. 3 Department of Pharmacology and Toxicology, Radboud Institute of Health Sciences, Nijmegen, The Netherlands
  4. 4 Department of Pediatric Surgery and Intensive Care, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands
  5. 5 Department of Clinical Pharmacy, Spaarne Gasthuis Hospital, Haarlem, The Netherlands
  6. 6 Pharmacy Foundation of Haarlem Hospitals, Haarlem, The Netherlands
  1. Correspondence to Dr Karlijn J van Stralen, Spaarne Gasthuis Academy, Spaarne Gasthuis, Haarlem 2033, Netherlands; kvanstralen{at}


Objective When infants suffer from nasal congestion, xylometazoline spray or drops can be effective to facilitate breathing and drinking. However, case reports on side effects have resulted in international warnings regarding use of xylometazoline in infants. Nevertheless, the incidence of these side effects in hospitalised infants is unknown.

Design Retrospective cohort study.

Setting Teaching hospital between 2017 and 2021.

Patients Infants under 2 years of age.

Exposure Receiving either saline-only (unlimited frequency, concentration 0.9%) or in combination with xylometazoline (maximum three times daily, concentration 0.025%).

Main outcome measures Predefined potential side effects (events), including among others apnoea, nausea, bradycardia, cyanosis and nosebleeds, were extracted from patient records, and the probability to be caused by saline only or xylometazoline–saline was determined using the ADR Probability Scale.

Results We included 898 admitted children during 1285 treatment episodes who received saline with or without xylometazoline. 26 events occurred in the saline-only group (incidence 20.0/100 treatment episodes), and 117 events occurred in the xylometazoline saline group (incidence of 10.5/100 treatment episodes), which was significantly lower (OR 0.47 95% CI 0.29 to 0.75, p=0.002). No definite linked or life-threatening events were found. Three nosebleeds had a probable link to the use of xylometazoline–saline, and all other events could only possibly be linked to saline-only or xylometazoline saline use. The incidence of all events was higher in the saline-only group as compared with the xylometazoline saline group, except nausea, which had a similar occurrence (p=0.65). Results were very similar across (gestational) age groups, gender and reasons for admission.

Conclusion The use of low-dose xylometazoline seems to be safe in hospitalised infants.

  • Respiratory Medicine
  • Therapeutics
  • Toxicology
  • Epidemiology
  • Paediatrics

Data availability statement

Data are available on reasonable request. Data are available on a reasonable request via

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Data availability statement

Data are available on reasonable request. Data are available on a reasonable request via

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  • Contributors KJvS and MAvH had the idea for the study. JvT collected the data, and KJvS and JvT performed the analyses and wrote the first draft of the paper. SNdW and MB provided important infrormation on the interpretation of the data and development of the scores, and KvS, MAvH, SNdW and MB critically revised the manuscript. KJvS is guarantor.

  • Funding This research received no specific grant from any funding agencies in the public, commercial or non-for-profit sector. MAvH and MB were supported by the Spaarne Gasthuis for performing their research.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.