AZELASTINE HYDROCHLORIDE

N/A

Manufactured by Alembic Pharmaceuticals Limited

14,064 FDA adverse event reports analyzed

Last updated: 2026-04-15

About AZELASTINE HYDROCHLORIDE

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

Top Adverse Reactions

TREATMENT FAILURE781 reports
PRODUCT DOSE OMISSION ISSUE584 reports
DRUG INEFFECTIVE561 reports
FATIGUE415 reports
HEADACHE370 reports
NO ADVERSE EVENT370 reports
DYSPNOEA348 reports
COUGH319 reports
PRODUCT DELIVERY MECHANISM ISSUE308 reports
NAUSEA295 reports
SINUSITIS283 reports
COVID 19261 reports
PAIN256 reports
DIARRHOEA245 reports
DIZZINESS234 reports
PNEUMONIA209 reports
ASTHMA207 reports
ARTHRALGIA189 reports
FALL181 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION170 reports
MALAISE168 reports
OFF LABEL USE165 reports
PRURITUS165 reports
PRODUCT USE IN UNAPPROVED INDICATION158 reports
RASH155 reports
NASOPHARYNGITIS154 reports
ASTHENIA142 reports
ILLNESS142 reports
URINARY TRACT INFECTION142 reports
VOMITING140 reports
WEIGHT DECREASED134 reports
HYPERSENSITIVITY132 reports
INFECTION132 reports
INJECTION SITE PAIN132 reports
BACK PAIN127 reports
PYREXIA126 reports
CONDITION AGGRAVATED125 reports
PAIN IN EXTREMITY122 reports
BRONCHITIS121 reports
INSOMNIA114 reports
SEASONAL ALLERGY112 reports
FEELING ABNORMAL111 reports
EYE PAIN107 reports
UPPER RESPIRATORY TRACT INFECTION107 reports
NASAL CONGESTION106 reports
OROPHARYNGEAL PAIN105 reports
WEIGHT INCREASED101 reports
BLOOD PRESSURE INCREASED100 reports
PRODUCT USE ISSUE99 reports
ANXIETY96 reports
INFLUENZA94 reports
SOMNOLENCE93 reports
CONSTIPATION91 reports
MIGRAINE87 reports
PRODUCTIVE COUGH87 reports
CHEST DISCOMFORT86 reports
DEVICE ISSUE86 reports
INFUSION SITE PAIN85 reports
PERIPHERAL SWELLING85 reports
ABDOMINAL PAIN UPPER84 reports
DEVICE BREAKAGE84 reports
DECREASED APPETITE83 reports
MUSCLE SPASMS81 reports
RHINORRHOEA81 reports
DRUG HYPERSENSITIVITY80 reports
CONTUSION77 reports
DEPRESSION77 reports
EAR INFECTION77 reports
DEATH75 reports
VISION BLURRED75 reports
EPISTAXIS74 reports
HYPERTENSION74 reports
MULTIPLE ALLERGIES74 reports
CHILLS73 reports
GAIT DISTURBANCE73 reports
DEVICE MALFUNCTION72 reports
ABDOMINAL DISCOMFORT70 reports
RESPIRATORY TRACT INFECTION69 reports
SINUS DISORDER69 reports
URTICARIA69 reports
INFUSION SITE ERYTHEMA68 reports
EYE IRRITATION67 reports
DYSGEUSIA66 reports
HYPOTENSION66 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS66 reports
ABDOMINAL DISTENSION65 reports
ACCIDENTAL EXPOSURE TO PRODUCT65 reports
ERYTHEMA65 reports
THROAT IRRITATION65 reports
CHEST PAIN64 reports
INCORRECT DOSE ADMINISTERED64 reports
DRY SKIN63 reports
WHEEZING62 reports
MYALGIA61 reports
INSURANCE ISSUE60 reports
DRY MOUTH59 reports
DRY EYE58 reports
INFUSION RELATED REACTION58 reports
VIRAL INFECTION56 reports
HYPOAESTHESIA55 reports

Report Outcomes

Out of 5,917 classified reports for AZELASTINE HYDROCHLORIDE:

Serious 28.2%Non-Serious 71.8%

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

Female3,739 (69.2%)
Male1,664 (30.8%)
Unknown1 (0.0%)

Reports by Age

Age 6786 reports
Age 6576 reports
Age 7071 reports
Age 7471 reports
Age 6867 reports
Age 7165 reports
Age 7563 reports
Age 5862 reports
Age 6162 reports
Age 6061 reports
Age 6461 reports
Age 6661 reports
Age 6259 reports
Age 6957 reports
Age 7255 reports
Age 5953 reports
Age 5552 reports
Age 7648 reports
Age 6346 reports
Age 7343 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 HYDROCHLORIDE?

This profile reflects 14,064 FDA FAERS reports that mention AZELASTINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AZELASTINE HYDROCHLORIDE?

Frequently reported terms in FAERS include TREATMENT FAILURE, PRODUCT DOSE OMISSION ISSUE, DRUG INEFFECTIVE, FATIGUE, HEADACHE, NO ADVERSE EVENT. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AZELASTINE HYDROCHLORIDE?

Labeling and FAERS entries often list Alembic Pharmaceuticals Limited in connection with AZELASTINE 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.