OXYMETAZOLINE HYDROCHLORIDE

N/A

Manufactured by Bayer HealthCare LLC.

8,811 FDA adverse event reports analyzed

Last updated: 2026-04-15

About OXYMETAZOLINE HYDROCHLORIDE

OXYMETAZOLINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare LLC.. The most commonly reported adverse reactions for OXYMETAZOLINE HYDROCHLORIDE include DRUG DEPENDENCE, DRUG INEFFECTIVE, ANOSMIA, DYSPNOEA, PRODUCT USE ISSUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXYMETAZOLINE HYDROCHLORIDE.

Top Adverse Reactions

DRUG DEPENDENCE1,088 reports
DRUG INEFFECTIVE367 reports
ANOSMIA282 reports
DYSPNOEA249 reports
PRODUCT USE ISSUE196 reports
HEADACHE194 reports
AGEUSIA180 reports
FATIGUE173 reports
NAUSEA173 reports
NASAL CONGESTION153 reports
DIARRHOEA151 reports
NASAL DISCOMFORT150 reports
PAIN147 reports
DIZZINESS131 reports
EPISTAXIS130 reports
OFF LABEL USE121 reports
SINUSITIS116 reports
INSOMNIA113 reports
CONDITION AGGRAVATED110 reports
ANXIETY106 reports
COUGH103 reports
PNEUMONIA102 reports
FEELING ABNORMAL101 reports
PRURITUS99 reports
RHINORRHOEA89 reports
ASTHENIA88 reports
APPLICATION SITE ERYTHEMA82 reports
FALL82 reports
VOMITING81 reports
DEPRESSION78 reports
WEIGHT DECREASED78 reports
BURNING SENSATION76 reports
DRUG EFFECT DECREASED76 reports
RASH76 reports
INCORRECT DRUG ADMINISTRATION DURATION75 reports
ARTHRALGIA74 reports
INCORRECT PRODUCT ADMINISTRATION DURATION74 reports
MALAISE73 reports
HYPERSENSITIVITY69 reports
PYREXIA68 reports
REBOUND EFFECT68 reports
ERYTHEMA67 reports
SOMNOLENCE66 reports
PRODUCT DOSE OMISSION ISSUE65 reports
CONSTIPATION63 reports
NASOPHARYNGITIS62 reports
PAIN IN EXTREMITY62 reports
DEATH61 reports
HYPERTENSION61 reports
DEPENDENCE60 reports
BLOOD PRESSURE INCREASED58 reports
PRODUCT USE IN UNAPPROVED INDICATION57 reports
DYSGEUSIA56 reports
APPLICATION SITE PAIN55 reports
BACK PAIN54 reports
CHEST PAIN54 reports
PARAESTHESIA54 reports
COVID 1953 reports
ACCIDENTAL EXPOSURE TO PRODUCT52 reports
REBOUND NASAL CONGESTION52 reports
ROSACEA52 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION51 reports
SINUS DISORDER51 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS51 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION50 reports
HYPOTENSION48 reports
URINARY TRACT INFECTION48 reports
URTICARIA48 reports
DECREASED APPETITE46 reports
PRODUCT QUALITY ISSUE46 reports
TREMOR46 reports
HEART RATE INCREASED45 reports
DRUG HYPERSENSITIVITY44 reports
ABDOMINAL PAIN UPPER43 reports
OROPHARYNGEAL PAIN43 reports
PALPITATIONS43 reports
SNEEZING43 reports
WEIGHT INCREASED43 reports
DEHYDRATION41 reports
HYPOAESTHESIA41 reports
MIGRAINE41 reports
ABDOMINAL PAIN40 reports
INCORRECT DOSE ADMINISTERED40 reports
DYSPEPSIA39 reports
INFLUENZA39 reports
MUSCLE SPASMS39 reports
ACUTE KIDNEY INJURY38 reports
ABDOMINAL DISCOMFORT37 reports
OVERDOSE37 reports
UPPER RESPIRATORY TRACT INFECTION37 reports
CONFUSIONAL STATE36 reports
GAIT DISTURBANCE36 reports
HYPERHIDROSIS36 reports
PRODUCT CONTAINER ISSUE36 reports
CEREBROVASCULAR ACCIDENT35 reports
ASTHMA34 reports
DYSPHAGIA34 reports
PERIPHERAL SWELLING34 reports
ATRIAL FIBRILLATION33 reports
OEDEMA PERIPHERAL33 reports

Report Outcomes

Out of 4,855 classified reports for OXYMETAZOLINE HYDROCHLORIDE:

Serious 55.4%Non-Serious 44.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female2,350 (59.3%)
Male1,587 (40.0%)
Unknown26 (0.7%)

Reports by Age

Age 6276 reports
Age 6662 reports
Age 7155 reports
Age 5851 reports
Age 6451 reports
Age 6148 reports
Age 6347 reports
Age 7444 reports
Age 5443 reports
Age 5643 reports
Age 6543 reports
Age 6943 reports
Age 6042 reports
Age 4741 reports
Age 5741 reports
Age 7241 reports
Age 2740 reports
Age 6740 reports
Age 3539 reports
Age 5939 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with OXYMETAZOLINE HYDROCHLORIDE?

This profile reflects 8,811 FDA FAERS reports that mention OXYMETAZOLINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OXYMETAZOLINE HYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG DEPENDENCE, DRUG INEFFECTIVE, ANOSMIA, DYSPNOEA, PRODUCT USE ISSUE, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures OXYMETAZOLINE HYDROCHLORIDE?

Labeling and FAERS entries often list Bayer HealthCare LLC. in connection with OXYMETAZOLINE HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.