Sold as Pataday, PATANASE.
Class: Antiallergic agents, excl. corticosteroids.
First FDA approval 12/18/1996: 30 years on the US market.
This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
B
Score breakdown (85/100)
Safety ×35%
A
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
A
Options ×10%
A
Safety: 100
Death share in reports is near or below the FAERS average (0.4x)
Evidence: 47
87 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed
No Cochrane review found (-5)
Regulatory history: 91
Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 29 generic makers (-1)
5 label changes approved since 2021: the safety story is still moving (-8)
Money & lawsuits: 100
Pharma paid doctors $52,649 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 100
Generic versions approved (29 applications)
6 same-class alternatives exist
What the FDA label says
Approved uses
Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
Contraindications
None listed.
Warnings and precautions
Warnings For external use only
Adverse reactions (label)
Not available.
Source: FDA SPL label for PATADAY ONCE DAILY RELIEF (Alcon Laboratories, Inc.), effective 20260120.
Full label on DailyMed.
Side-effect reports sent to the FDA
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
17,580reports that mention this drug
17,571of those blame this drug, not another one the person was taking
33%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
3.2%of reports include a death, from any cause (average for all drugs: 9.1%)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
Recalls and regulatory record
1recall actions on file
4 / 29brand / generic applications
5label changes since 2021
NoREMS program
Date
Class
Firm
Reason
06/2022
Class II
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Evidence base
87randomized trials (PubMed)
2systematic reviews
65registered trials
64%of completed trials posted results
8%terminated or withdrawn
89%industry-funded
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
Money and lawsuits
In 2024, drug companies reported $52,649 in payments to US physicians and hospitals tied to this drug across 23 transactions (Pataday $52,649).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.
Questions to ask your prescriber
The most-reported problems in FDA's adverse event data are treatment failure, eye irritation, headache. How would we recognize and handle those?
Why this one over antazoline, azelastine, cromolyn? What would make you pick one of those instead?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)