What the label lists and what reports show
Oxymetazoline side effects
Oxymetazoline's FDA label: “Most common adverse reactions (incidence ≥ 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain.” FAERS holds 6,779 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug dependence (1,129 reports).
- Generic listed
Check it at the source: the oxymetazoline FDA label on DailyMed (effective July 13, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Oxymetazoline Hydrochloride Cream?The most common side effects of Oxymetazoline Hydrochloride Cream include application site reactions of: skin reactions (dermatitis) worsening of rosacea pimples itching redness pain These are not all the possible side effects of Oxymetazoline Hydrochloride Cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Mayne Pharma, effective July 13, 2026 (SPL set 34298db6-647d-480d-88a8-dc53258a5164), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain.
Table 1: Adverse Reactions Reported by ≥ 1% of Subjects through 4 Weeks of Treatment in Controlled Clinical Trials
| Reaction | Adverse Reaction Oxymetazoline HCl Cream (N = 489) | Pooled Controlled Clinical Trials Vehicle Cream (N = 483) |
|---|---|---|
| Application site dermatitis | 9 (2%) | 0 |
| Worsening inflammatory lesions of rosacea | 7 (1%) | 1 (<1%) |
| Application site pruritus | 5 (1%) | 4 (1%) |
| Application site erythema | 5 (1%) | 2 (<1%) |
| Application site pain | 4 (1%) | 1 (<1%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions (incidence ≥ 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 489 subjects with persistent facial erythema associated with rosacea were treated with Oxymetazoline Hydrochloride Cream once daily for 4 weeks in 3 controlled clinical trials. An additional 440 subjects with persistent facial erythema associated with rosacea were also treated with Oxymetazoline Hydrochloride Cream once daily for up to one year in a long-term (open- label) clinical trial. Adverse reactions that occurred in at least 1% of subjects treated with Oxymetazoline Hydrochloride Cream through 4 weeks of treatment are presented in Table 1 below.
Source: FDA drug label, Mayne Pharma, effective July 13, 2026 (SPL set 34298db6-647d-480d-88a8-dc53258a5164), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,779 reports list oxymetazoline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 165 are coded as a death and 708 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Oxymetazoline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions