Decongestant nasal sprays
Small trials found decongestant sprays opened the nose for hours in colds, more than placebo, and modestly cut ear pain on flights. Adding one to a nasal steroid gave mixed results. Trials of daily use disagreed on rebound congestion. Case reports link overuse to stroke and heart events, and swallowing by small children to slowed heart rate and breathing.
- Status
- Sold over the counter in the US under FDA's nasal decongestant monograph, which lists oxymetazoline, xylometazoline, phenylephrine, naphazoline and other topical decongestants. Labels direct use for no more than 3 days, oxymetazoline from age 6 and phenylephrine 0.5% from age 12. FDA's 2024 proposal to remove phenylephrine covers the oral form only, not nasal sprays.
- Also called
- oxymetazoline, Afrin, Afrin No Drip, Zicam Extreme Congestion, Vicks Sinex, Mucinex Sinus-Max nasal spray, xylometazoline, Otrivin, phenylephrine nasal spray, Neo-Synephrine, naphazoline, Privine, topical nasal decongestant, imidazoline decongestant, rebound congestion, rhinitis medicamentosa, nasal spray addiction
- Taken for
- stuffy nose, nasal congestion from a cold, sinus congestion and pressure, hay fever congestion, ear pain on flights, adding to a nasal steroid spray, nosebleeds, breathing through the nose to sleep
Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on
Shown to help1
Reported risks7
- LimitedSmall trials disagree. Some found rebound swelling after 3 to 30 days of oxymetazoline, others found none after 10 days to 4 weeks. The labels warn of it.How often is not known
- LimitedOne trial found 14 days of oxymetazoline cut nasal airflow and the spray's effect, reversed by adding fluticasone. Other trials found no loss of effect over 1 to 4 weeks.How often is not known
- LimitedSmall trials found the preservative benzalkonium chloride caused nasal swelling over a month and changed nasal reactivity after 10 days.How often is not known
- LimitedThe labels warn of brief burning, stinging, sneezing and more nasal discharge. In cold trials, adverse events matched placebo, about 12.5% in each group.How often is not known
- LimitedCase reports: heavy or long-term overuse of oxymetazoline or xylometazoline sprays was followed by cardiac arrest, heart muscle injury, hypertensive crisis and stroke.How often is not known
- LimitedCase reports: in small children, 1 to 2 mL of oxymetazoline caused slow heart rate and depressed breathing. An upside-down bottle delivered 20 to 30 times more in lab tests.How often is not known
- LimitedLinked in a case-control study to a few uncommon birth defects with early-pregnancy decongestant use, in hypothesis-generating analyses that included nasal decongestants.How often is not known
What people take it for, and what was found
Shown to help1
Stuffy nose from a cold
Small trials found decongestants eased cold congestion slightly more than placebo, and xylometazoline spray raised nasal airflow for up to 10 hours.
The numbers and sources
- Effect
- Pooling two multi-dose trials, one oral and one topical, subjective congestion was better than placebo about 3 hours after the last dose (SMD 0.49, 95% CI 0.07 to 0.92, low quality), a small effect. Single-dose trials could not be pooled [1]. In a trial of xylometazoline 0.1%, one spray three times a day for up to 10 days, nasal conductance at 1 hour was 384 against 226 cm3/s on saline placebo, and stayed higher for up to 10 hours. Total cold symptom scores and patient satisfaction also favored xylometazoline [2].
- Population
- 1,838 participants in 15 trials, 14 of them in adults only, 4 using topical decongestants (3 oxymetazoline, 1 xylometazoline) [1]; 61 adults with a common cold [2].
- Sources
- [1], [2]
- Caveats
- Most trials in [1] used oral pseudoephedrine, and the topical and oral effects could not be separated [1]. The xylometazoline trial is small. No modern placebo-controlled trial of phenylephrine nasal spray was located.
Mixed results2
Adding a decongestant spray to a nasal steroid
Mixed results: one meta-analysis found no added benefit over a nasal steroid alone, while a review of four trials found more relief of congestion with oxymetazoline added.
Compared with a nasal steroid alone [3][4]; placebo and oxymetazoline alone [5]
The numbers and sources
- Effect
- Across 6 trials of chronic rhinitis, a decongestant added to a nasal steroid did not change total nasal symptom score (SMD -0.85, 95% CI -2.09 to 0.40), congestion score (SMD -0.13) or quality of life, or nasal patency after 1 week. Adverse events did not differ (RR 1.09, 95% CI 0.73 to 1.62) [3]. A review of 4 trials of oxymetazoline with a nasal steroid found greater improvement in congestion than control groups, without rhinitis medicamentosa [4]. In one 4-week trial in perennial allergy, nightly fluticasone furoate plus oxymetazoline lowered total nasal symptom score (median 143) against placebo (262) and oxymetazoline alone (219), and gave higher nasal volume (15.8 against 12.1 and 12.4 mL). No rhinitis medicamentosa appeared over 2 weeks of follow-up [5].
- Population
- 1,071 patients in 6 randomized trials [3]; 838 patients in 4 randomized trials [4]; 60 adults with perennial allergic rhinitis [5].
- Sources
- [3], [4], [5]
- Caveats
- The two reviews overlap and reached opposite conclusions. [3] found wide confidence intervals.
Ear pain and blockage on flights
Mixed results: oxymetazoline spray before flying cut ear barotrauma modestly against placebo, by about a quarter, with inconsistent results across symptoms.
Compared with placebo [6][7]; oral pseudoephedrine [7]
The numbers and sources
- Effect
- In 2 trials, oxymetazoline lowered the risk of otic barotrauma (RR 0.75, 95% CI 0.57 to 0.99, P = 0.05), with moderate heterogeneity (I2 53%) and inconsistent effects on ear pain, blockage and hearing loss. Oral pseudoephedrine in 3 trials lowered it more (RR 0.55) [6]. In one airport trial, barotrauma symptoms were reported by 64% on oxymetazoline 0.05%, 71% on placebo and 34% on pseudoephedrine 120 mg [7].
- Population
- 490 adults in 4 double-blind randomized trials run 1992 to 1998 [6]; 124 adult air travelers with a history of ear pain on flights [7].
- Sources
- [6], [7]
- Caveats
- The trials are old and small [6]. One review.
Claimed, not studied in people1
Sinus infections in children
Not studied in people. A Cochrane search found no trial of decongestants in children with acute sinusitis. Labels list sinus congestion as a use from age 6.
No study in people. This rests on how it acts in the body.
The numbers and sources
- Effect
- Of 662 studies screened, none met the review's criteria, so there is no evidence on whether decongestants, antihistamines or nasal irrigation help children with acute sinusitis [8]. The oxymetazoline label lists temporary relief of sinus congestion and pressure as a use, by shrinking swollen nasal membranes, from age 6 [9].
- Population
- Children under 18 with acute sinusitis, no eligible trials [8].
- Sources
- [8], [9]
- Caveats
- The label use rests on how the drug narrows nasal blood vessels, not on a pediatric sinusitis trial.
Doses studied
FDA's monograph lists oxymetazoline, xylometazoline, phenylephrine, naphazoline, ephedrine, levmetamfetamine and propylhexedrine as topical nasal decongestant ingredients, each within set dosage limits [28]. FDA's November 2024 proposal to remove phenylephrine as a decongestant applies to the oral form, and FDA states it does not cover the nasal spray form [27]. The oxymetazoline 0.05% label directs 2 or 3 sprays in each nostril no more often than every 10 to 12 hours, no more than 2 doses in 24 hours, for adults and children 6 and older, and no more than 3 days [9]. The phenylephrine 0.5% label directs 2 or 3 sprays in each nostril no more often than every 4 hours, from age 12, for no more than 3 days [10]. The xylometazoline cold trial used 0.1%, one spray three times a day for up to 10 days [2]. Rebound trials used oxymetazoline 0.05% for 7 days [11], 10 days [12], 14 days at 200 mcg three times a day [13], and 4 weeks once nightly or three times daily [5][14][15]. The airplane trial used one dose 30 minutes before departure [7].
Risks
Reported risks5
The benzalkonium chloride preservative
Small trials found the preservative benzalkonium chloride caused nasal swelling over a month and changed nasal reactivity after 10 days.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Over 28 days, a spray of benzalkonium chloride alone raised nasal mucosal swelling, and it and placebo raised nasal reactivity less than oxymetazoline did [16]. Over 10 days, oxymetazoline with benzalkonium chloride lowered histamine sensitivity, and oxymetazoline without it did not. Neither caused rebound [12]. The Afrin and Neo-Synephrine labels list benzalkonium chloride among inactive ingredients [9][10].
- Population
- 30 healthy adults [16]; 35 adults with vasomotor rhinitis [12].
- Sources
- [16], [12], [9], [10]
- Caveats
- Small trials. The clinical meaning of the reactivity changes is not established.
Burning, stinging and other short-term effects
The labels warn of brief burning, stinging, sneezing and more nasal discharge. In cold trials, adverse events matched placebo, about 12.5% in each group.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- The labels state temporary burning, stinging, sneezing or more nasal discharge may occur, and that sharing a container may spread infection [9][10]. In 7 cold trials, adverse events occurred in 125 per 1,000 on a decongestant and 126 per 1,000 on placebo (OR 0.98, 95% CI 0.68 to 1.40), and only one of those trials was of a topical spray [1]. In the xylometazoline trial, 8 adverse events occurred on the drug and 11 on placebo [2].
- Population
- Adults with colds in 7 trials [1]; 61 adults [2].
- Sources
- [9], [10], [1], [2]
- Caveats
- The pooled rate is mostly from oral decongestants [1]. The labels give no rate for burning or stinging.
High blood pressure, heart attack and stroke with overuse
Case reports: heavy or long-term overuse of oxymetazoline or xylometazoline sprays was followed by cardiac arrest, heart muscle injury, hypertensive crisis and stroke.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- A 27-year-old man had a ventricular fibrillation cardiac arrest after excessive oxymetazoline use, with normal coronary arteries [19]. A 64-year-old woman had chest pain and raised cardiac biomarkers after oxymetazoline [20]. A young man had posterior circulation strokes after 10 years of xylometazoline misuse [21], and a 40-year-old woman died of a hemorrhagic stroke with xylometazoline in her blood [22]. A case report describes hypertensive crisis with end-organ damage after decongestant spray abuse [23]. The labels say to ask a doctor before use with heart disease, high blood pressure, thyroid disease, diabetes or trouble urinating from an enlarged prostate [9][10].
- Population
- Single case reports [19][20][21][22][23].
- Sources
- [19], [20], [21], [22], [23], [9], [10]
- Caveats
- Case reports cannot show cause or give a rate. Most involved use far above label doses.
Children: overdose and swallowing
Case reports: in small children, 1 to 2 mL of oxymetazoline caused slow heart rate and depressed breathing. An upside-down bottle delivered 20 to 30 times more in lab tests.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- In overdoses as small as 1 to 2 mL, oxymetazoline toxicity in children included bradycardia and respiratory depression. Inverting the container delivered 20 to 30 times the volume of an upright spray in an in vitro model [24]. The American Academy of Pediatrics reports cardiac and respiratory complications with oxymetazoline in children, notes the label approval is for ages 6 and older, and states adequate pediatric pharmacokinetic studies are lacking [25]. The label says to get medical help or contact a Poison Control Center right away if swallowed, and to ask a doctor for children under 6 [9].
- Population
- Pediatric case reports summarized in [24][25]; laboratory spray model [24].
- Sources
- [24], [25], [9]
- Caveats
- No rate is available. The dose measurement was in a lab model, not in children [24].
Pregnancy
Linked in a case-control study to a few uncommon birth defects with early-pregnancy decongestant use, in hypothesis-generating analyses that included nasal decongestants.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Among 12,734 infants with malformations and 7,606 without, analyses with multiple comparisons identified a small number of associations between first-trimester oral and intranasal decongestants and specific birth defects. Phenylephrine was linked to endocardial cushion defect (OR 8.0, 95% CI 2.5 to 25.3, 4 exposed cases) [26]. The labels say to ask a health professional before use in pregnancy [9][10].
- Population
- Mothers of infants in the US and Canada, 1993 to 2010 [26].
- Sources
- [26], [9], [10]
- Caveats
- Observational, with many comparisons and few exposed cases. The abstract does not say which phenylephrine findings were for the nasal route [26].
Mixed results2
Rebound congestion (rhinitis medicamentosa)
Small trials disagree. Some found rebound swelling after 3 to 30 days of oxymetazoline, others found none after 10 days to 4 weeks. The labels warn of it.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- In healthy volunteers, 30 days of oxymetazoline once nightly or three times daily caused rebound mucosal swelling (0.8 and 1.1 mm) and evening stuffiness scores of 43 of 100 [14]. A month of oxymetazoline raised nasal stuffiness and reactivity more than placebo [16]. Over 7 days, baseline airway resistance rose by day 3 in both oxymetazoline groups, with a similar trend on the vehicle spray [11]. In contrast, 4 weeks of oxymetazoline three times daily caused no increase in nasal blockage against placebo [15], 10 days caused no rebound in people with vasomotor rhinitis [12], and 4 weeks nightly with or without fluticasone furoate showed no rhinitis medicamentosa [5]. A French expert panel found the evidence discordant [17]. A review written by manufacturer employees found no rebound after 7 days of oxymetazoline or 10 days of xylometazoline [18]. The labels state frequent or prolonged use may cause congestion to recur or worsen, and limit use to 3 days [9][10].
- Population
- 20 healthy adults [14]; 30 healthy adults [16]; 50 healthy adults [11]; 30 healthy adults [15]; 35 adults with vasomotor rhinitis [12]; 60 adults with perennial allergy [5]; published studies reviewed in [17][18].
- Sources
- [14], [16], [11], [15], [12], [5], [17], [18], [9], [10]
- Caveats
- Every trial was small and most were in healthy volunteers, not people already overusing sprays. No trial gives a rate of rhinitis medicamentosa. [18] was funded by and written by staff of Haleon, which sells xylometazoline.
Weaker effect with daily use
One trial found 14 days of oxymetazoline cut nasal airflow and the spray's effect, reversed by adding fluticasone. Other trials found no loss of effect over 1 to 4 weeks.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- After 14 days of oxymetazoline 200 mcg three times a day, peak nasal inspiratory flow fell by 47.9 L/min against day 1 (95% CI 31.9 to 63.9), and the dose-response curve shifted down. Three days of fluticasone propionate 200 mcg twice daily raised inspiratory flow by 45 L/min [13]. No tolerance to oxymetazoline developed over 7 days [11], and the decongestant response was unchanged after 4 weeks three times daily [15].
- Population
- 19 healthy adults in a crossover trial [13]; 50 healthy adults [11]; 30 healthy adults [15].
- Sources
- [13], [11], [15]
- Caveats
- Small trials in healthy volunteers.
Related
Sources
- Deckx L, De Sutter AI, Guo L, Mir NA, van Driel ML. Nasal decongestants in monotherapy for the common cold. Cochrane Database of Systematic Reviews. 2016. https://doi.org/10.1002/14651858.cd009612.pub2
- Eccles R, Eriksson M, Garreffa S, Chen SC. The nasal decongestant effect of xylometazoline in the common cold. American Journal of Rhinology. 2008. https://doi.org/10.2500/ajr.2008.22.3202
- Khattiyawittayakun L, Seresirikachorn K, Chitsuthipakorn W, et al. Effects of decongestant addition to intranasal corticosteroid for chronic rhinitis: a systematic review and meta-analysis. International Forum of Allergy & Rhinology. 2018. https://doi.org/10.1002/alr.22193
- Neighbors CL, Salvador CF, Zhu B, Camacho M, Tsai P. Intranasal corticosteroid and oxymetazoline for chronic rhinitis: a systematic review. The Journal of Laryngology & Otology. 2022. https://doi.org/10.1017/s0022215121003364
- Baroody FM, Brown D, Gavanescu L, DeTineo M, Naclerio RM. Oxymetazoline adds to the effectiveness of fluticasone furoate in the treatment of perennial allergic rhinitis. Journal of Allergy and Clinical Immunology. 2011. https://doi.org/10.1016/j.jaci.2011.01.037
- AlGhamdi MA, Katib RI, Bawazir RO, et al. Efficacy of Pseudoephedrine and Oxymetazoline in Preventing Otic Barotrauma: A Systematic Review and Meta-Analysis. Otology & Neurotology. 2026. https://doi.org/10.1097/mao.0000000000004905
- Jones JS, Sheffield W, White LJ, Bloom MA. A double-blind comparison between oral pseudoephedrine and topical oxymetazoline in the prevention of barotrauma during air travel. The American Journal of Emergency Medicine. 1998. https://doi.org/10.1016/s0735-6757(98)90097-3
- Shaikh N, Wald ER. Decongestants, antihistamines and nasal irrigation for acute sinusitis in children. Cochrane Database of Systematic Reviews. 2014. https://doi.org/10.1002/14651858.cd007909.pub4
- U.S. Food and Drug Administration. AFRIN ORIGINAL PUMP MIST (oxymetazoline hydrochloride) nasal spray, drug facts label. 2025. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0f5ec576-f788-40aa-9088-0dd672e3cc7c
- U.S. Food and Drug Administration. NEO-SYNEPHRINE REGULAR (phenylephrine hydrochloride 0.5%) nasal spray, drug facts label. 2023. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab860c10-b8cf-3f92-e053-2a95a90a7317
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- Mortuaire G, de Gabory L, François M, et al. Rebound congestion and rhinitis medicamentosa: nasal decongestants in clinical practice. Critical review of the literature by a medical panel. European Annals of Otorhinolaryngology, Head and Neck Diseases. 2013. https://doi.org/10.1016/j.anorl.2012.09.005
- Hagen M, Varbiro G, Montanari E, Ballerini Fernandes M. Revisiting Rhinitis Medicamentosa: Examining the Evidence on Topical Nasal Decongestants. Journal of Pharmacy Practice. 2026. https://doi.org/10.1177/08971900251350510
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- Rajpal S, Morris LA, Akkus NI. Non-ST-elevation myocardial infarction with the use of oxymetazoline nasal spray. Revista Portuguesa de Cardiologia. 2014. https://doi.org/10.1016/j.repc.2013.07.011
- Leupold D, Wartenberg KE. Xylometazoline abuse induced ischemic stroke in a young adult. The Neurologist. 2011. https://doi.org/10.1097/nrl.0b013e3181d2ab04
- Banaś BP, Brzeźniakiewicz-Janus K, Majdanik S, et al. Hemorrhagic stroke caused by xylometazoline poisoning. Journal of Forensic Sciences. 2024. https://doi.org/10.1111/1556-4029.15416
- Buysschaert I, Van Dorpe J, Dujardin K. Hypertensive crisis and end-organ damage induced by over-the-counter nasal decongestant abuse. European Heart Journal. 2011. https://doi.org/10.1093/eurheartj/ehr199
- Nordt SP, Vivero LE, Cantrell FL. Not Just a Drop in the Bucket: Inversion of Oxymetazoline Nasal Decongestant Container Increases Potential for Severe Pediatric Poisoning. The Journal of Pediatrics. 2016. https://doi.org/10.1016/j.jpeds.2015.09.067
- Cartabuke R, Tobias JD, Jatana KR, et al. Topical Nasal Decongestant Oxymetazoline: Safety Considerations for Perioperative Pediatric Use. Pediatrics. 2021. https://doi.org/10.1542/peds.2021-054271
- Yau WP, Mitchell AA, Lin KJ, Werler MM, Hernández-Díaz S. Use of decongestants during pregnancy and the risk of birth defects. American Journal of Epidemiology. 2013. https://doi.org/10.1093/aje/kws427
- U.S. Food and Drug Administration. FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review. Press announcement. 2024. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after
- U.S. Food and Drug Administration. 21 CFR 341.20, Nasal decongestant active ingredients. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-341/subpart-B/section-341.20