Drug Safety Information for ASTEPRO (Azelastine hydrochloride)

Safety-related Labeling Changes for ASTELIN (AZELASTINE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for ASTEPRO (AZELASTINE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for DYMISTA (AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE) Rx Drug: FDA Link

Adverse Drug Reactions for ASTEPRO* (Azelastine hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ASTEPRO
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea323
2Nausea314
3Fatigue*279
4Pain259
5Dizziness*240
6Headache*235
7Drug ineffective234
8Diarrhoea177
9Vomiting174
10Anxiety*166
11Asthma165
12Cough158
13Arthralgia142
14Insomnia*141
15Chest pain140
16Back pain139
17Product quality issue139
18Pneumonia136
19Abdominal pain136
20Pyrexia132

* This side effect also appears in "Top 10 Side Effects of ASTEPRO " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ASTEPRO
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication2449
2Hypersensitivity*1393
3Rhinitis allergic*447
4Multiple allergies403
5Seasonal allergy365
6Rhinitis*240
7Nasal congestion*217
8Asthma173
9Sinus disorder99
10Hypertension93

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ASTEPRO

Total Reports Filed with FDA: 22814


Number of FDA Adverse Event Reports by Patient Age for ASTEPRO

Total Reports Filed with FDA: 22814*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Azelastine hydrochloride (Azelastine hcl nasal, Loxin, Rhinolast, Azelastine, Allergodil, Astelin, Astepro, Optivar)

Charts are based on 22814 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ASTEPRO Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.