Xylometazoline

Topical nasal vasoconstrictor, imidazoline derivative

ATC code: R01AA07

Brand names: Otrivin, Sudafed Blocked Nose Spray

Updated 24 Sep 2026 · Methodology

Indications

Nasal congestion

Second line

Xylometazoline clears congestion for 6 to 8 hours. The AEMPS ficha técnica frames the indication as temporary local relief of nasal congestion: adults and adolescents from 12 years get the 1 mg/ml spray, one spray per nostril twice a day and up to three times if needed; children from 6 to 12 years have a separate 0.5 mg/ml form. The 2016 Cochrane review of decongestants showed that in adults with a cold a single dose gives small relief of breathing, while in children no benefit is visible. The practical limit is 3 to 5 consecutive days: beyond it drug-induced rhinitis begins. Before buying, the ficha advises assessment for people with heart and vascular disease, hypertension, diabetes, thyroid disease, prostate enlargement, and for those taking tricyclic or tetracyclic antidepressants.

Sources

ICD-10: R09.8

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Chronic rhinosinusitis

Not recommended

In chronic rhinosinusitis a vasoconstrictor spray looks logical: the sinuses are blocked, so drainage should be opened. That treatment has no evidence base. The European EPOS 2020 paper builds chronic rhinosinusitis management on intranasal corticosteroids and saline rinses, and topical decongestants as standalone treatment are not part of it – their role is limited to short episodes of acute congestion. Chronic disease calls for a different conversation: polyps, allergy, anatomy, rarely fungal involvement, and some patients go to a surgeon. A permanent spray only lengthens that road and adds drug-induced rhinitis on top of the underlying disease. If xylometazoline was offered as treatment for chronic sinusitis, consider seeking a second opinion from an ear, nose and throat specialist.

Sources

ICD-10: J32.9 · ICD-11: CA0A

Non-allergic rhinitis

Not recommended

A bottle of xylometazoline that lives in a bag for months is the classic picture of drug-induced rhinitis. The mucosal vessels answer constant constriction with rebound dilation, the nose blocks harder, the person sprays more often and the loop locks in. The European EPOS 2020 paper on rhinosinusitis directly lists prolonged use of topical decongestants among the causes of chronic nasal obstruction. That is exactly why the AEMPS ficha técnica limits the course to a few days. Three things break the loop: stopping the drug, rinsing the nose with saline, and an intranasal corticosteroid prescribed by a doctor while the lining recovers. The first 5 to 7 days after stopping are the hardest. If a vasoconstrictor spray is advised to be «kept handy» for months, consider seeking a second opinion.

Sources

ICD-10: J30.0 · ICD-11: CA08.1

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

A sympathomimetic with marked alpha-adrenergic activity on nasal mucosal receptors. After a spray the vessels narrow, the swelling subsides and the nose and nasopharynx open; in people with sinusitis drainage from the sinuses improves as well. Xylometazoline differs from oxymetazoline in its shorter-acting molecule: the effect lasts 6 to 8 hours, so adults are given up to three applications a day. Pediatric forms hold half the concentration, 0.5 mg/ml, and are allowed from 6 years. The property that forbids long use is shared across the group: the mucosa answers regular vasoconstriction with rebound dilation, and congestion returns stronger than before.

Safety

Contraindications

Hypersensitivity to xylometazoline and other adrenergic decongestants
State after transsphenoidal hypophysectomy or other surgery exposing the dura mater
Children under 6 years for the 0.5 mg/ml form and under 12 years for the 1 mg/ml form
Pregnancy and breastfeeding

Serious adverse effects

Drug-induced rhinitis with prolonged use
Systemic allergic reactions
Palpitations, tachycardia, rise in blood pressure
Agitation and sleep disturbance, especially in children

Common adverse effects

Burning in the nose and throat
Dryness and irritation of the nasal lining
Sneezing
Nosebleed
Headache

Pregnancy: can you take Xylometazoline?

Absorption from the nasal lining is small, but the available data do not allow fetal risk to be excluded. Xylometazoline is not used in pregnancy.

Breastfeeding: can you take Xylometazoline?

Whether xylometazoline passes into breast milk is unknown; no harm to the infant has been described, yet the product is not recommended while breastfeeding.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions2 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

MajorIMAOclass named in the label
«inhibidores de la monoaminooxidasa (IMAO)»
AEMPS, section 4.5 · Open on CIMA
MajorMethyldopa
«Metildopa.»
AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Xylometazoline used for?

Xylometazoline is evaluated for the following indications with varying evidence strength: Nasal congestion (evidence tier B), Chronic rhinosinusitis (evidence tier D), Non-allergic rhinitis (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Xylometazoline?

Common side effects of Xylometazoline (≥ 1 in 100): Burning in the nose and throat, Dryness and irritation of the nasal lining, Sneezing, Nosebleed, Headache. See the Safety section for uncommon and serious reactions.

Is Xylometazoline safe during pregnancy?

Absorption from the nasal lining is small, but the available data do not allow fetal risk to be excluded. Xylometazoline is not used in pregnancy.

Is Xylometazoline compatible with breastfeeding?

Whether xylometazoline passes into breast milk is unknown; no harm to the infant has been described, yet the product is not recommended while breastfeeding.

Who should not take Xylometazoline?

Xylometazoline is contraindicated in: Hypersensitivity to xylometazoline and other adrenergic decongestants; State after transsphenoidal hypophysectomy or other surgery exposing the dura mater; Children under 6 years for the 0.5 mg/ml form and under 12 years for the 1 mg/ml form; Pregnancy and breastfeeding. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

AEMPS / CIMA

Other drugs in this group

Fluticasone furoate (nasal), Interferon alpha-2b (nasal formulations), Mometasone furoate (nasal), Oxymetazoline, Pseudoephedrine