AZELASTINE

N/A

Manufactured by Amneal Pharmaceuticals LLC

33,765 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AZELASTINE

AZELASTINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for AZELASTINE include TREATMENT FAILURE, DRUG INEFFECTIVE, FATIGUE, PRODUCT DOSE OMISSION ISSUE, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AZELASTINE.

Top Adverse Reactions

TREATMENT FAILURE1,876 reports
DRUG INEFFECTIVE1,155 reports
FATIGUE1,144 reports
PRODUCT DOSE OMISSION ISSUE889 reports
HEADACHE883 reports
NAUSEA879 reports
DYSPNOEA837 reports
DIARRHOEA766 reports
PAIN755 reports
COUGH719 reports
SINUSITIS685 reports
DIZZINESS615 reports
ASTHMA544 reports
OFF LABEL USE536 reports
PNEUMONIA535 reports
ARTHRALGIA516 reports
COVID 19506 reports
FALL488 reports
RASH476 reports
PRURITUS464 reports
NO ADVERSE EVENT443 reports
MALAISE441 reports
ASTHENIA435 reports
VOMITING398 reports
ANXIETY394 reports
INSOMNIA364 reports
NASOPHARYNGITIS363 reports
CONDITION AGGRAVATED356 reports
WEIGHT DECREASED344 reports
BACK PAIN341 reports
PRODUCT USE IN UNAPPROVED INDICATION341 reports
PYREXIA338 reports
URINARY TRACT INFECTION325 reports
PAIN IN EXTREMITY323 reports
PRODUCT DELIVERY MECHANISM ISSUE318 reports
CONSTIPATION314 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION298 reports
DEATH295 reports
FEELING ABNORMAL292 reports
HYPERSENSITIVITY291 reports
INJECTION SITE PAIN288 reports
INFECTION285 reports
BRONCHITIS282 reports
DEPRESSION279 reports
WEIGHT INCREASED263 reports
ILLNESS258 reports
MUSCLE SPASMS257 reports
SOMNOLENCE256 reports
BLOOD PRESSURE INCREASED252 reports
DECREASED APPETITE246 reports
PRODUCT USE ISSUE240 reports
PERIPHERAL SWELLING238 reports
CHRONIC KIDNEY DISEASE229 reports
ABDOMINAL PAIN UPPER219 reports
NASAL CONGESTION215 reports
OROPHARYNGEAL PAIN214 reports
HYPERTENSION213 reports
MIGRAINE207 reports
GAIT DISTURBANCE205 reports
ABDOMINAL DISCOMFORT204 reports
CHEST PAIN201 reports
INFLUENZA200 reports
UPPER RESPIRATORY TRACT INFECTION196 reports
RHINORRHOEA194 reports
URTICARIA194 reports
CHEST DISCOMFORT191 reports
DRUG HYPERSENSITIVITY188 reports
GASTROOESOPHAGEAL REFLUX DISEASE182 reports
MEMORY IMPAIRMENT182 reports
MYALGIA182 reports
ERYTHEMA176 reports
VISION BLURRED176 reports
WHEEZING176 reports
CONTUSION173 reports
EPISTAXIS171 reports
CHILLS170 reports
RENAL FAILURE170 reports
ABDOMINAL PAIN169 reports
HYPOAESTHESIA169 reports
HYPOTENSION167 reports
PRODUCTIVE COUGH167 reports
TREMOR167 reports
DEHYDRATION165 reports
SEASONAL ALLERGY164 reports
EYE PAIN159 reports
IMPAIRED QUALITY OF LIFE157 reports
INCORRECT DOSE ADMINISTERED156 reports
ANAEMIA155 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS155 reports
DRY EYE151 reports
PARAESTHESIA147 reports
EAR INFECTION146 reports
ABDOMINAL DISTENSION142 reports
SINUS DISORDER141 reports
DRY MOUTH140 reports
DRY SKIN140 reports
EYE IRRITATION140 reports
PALPITATIONS139 reports
ACUTE KIDNEY INJURY138 reports
SURGERY137 reports

Report Outcomes

Out of 16,650 classified reports for AZELASTINE:

Serious 40.1%Non-Serious 59.9%

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

Female10,573 (68.2%)
Male4,923 (31.7%)
Unknown11 (0.1%)

Reports by Age

Age 67249 reports
Age 68240 reports
Age 70230 reports
Age 65220 reports
Age 71218 reports
Age 74210 reports
Age 64208 reports
Age 69206 reports
Age 62201 reports
Age 61198 reports
Age 63193 reports
Age 66190 reports
Age 72190 reports
Age 73189 reports
Age 60185 reports
Age 58184 reports
Age 75182 reports
Age 56173 reports
Age 54166 reports
Age 76164 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 AZELASTINE?

This profile reflects 33,765 FDA FAERS reports that mention AZELASTINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AZELASTINE?

Frequently reported terms in FAERS include TREATMENT FAILURE, DRUG INEFFECTIVE, FATIGUE, PRODUCT DOSE OMISSION ISSUE, HEADACHE, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AZELASTINE?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with AZELASTINE. 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.