Drug Safety Information for PATANASE (Olopatadine hydrochloride)

Safety-related Labeling Changes for PATANASE ( OLOPATADINE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for PAZEO (OLOPATADINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for PATANASE* (Olopatadine 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 PATANASE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fatigue173
2Nausea170
3Headache*165
4Dyspnoea161
5Drug ineffective*144
6Rash129
7Diarrhoea129
8Pain*124
9Dizziness121
10Malaise114
11Pyrexia111
12Arthralgia107
13Vomiting98
14Cough89
15Asthenia88
16Pain in extremity86
17Pruritus86
18Back pain83
19Anxiety83
20Fall79

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

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

Reason # of FDA Reports
1Product used for unknown indication1344
2Hypersensitivity942
3Eye allergy306
4Multiple allergies209
5Seasonal allergy194
6Eye pruritus162
7Dry eye154
8Rhinitis allergic*139
9Conjunctivitis allergic*138
10Eye disorder91

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


Types of Adverse Events for PATANASE

Total Reports Filed with FDA: 13584


Number of FDA Adverse Event Reports by Patient Age for PATANASE

Total Reports Filed with FDA: 13584*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Olopatadine hydrochloride (Pazeo, Olopatadine, Pataday, Patanol, Patanase)

Charts are based on 13584 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 PATANASE 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.