Generic name
Latanoprost ophthalmic solution 0.005%: adverse event reports filed with FDA
534 reports list it as a suspect or interacting product, 2012–2021. Class: Prostaglandin analog.
- 534
- reports as suspect product
- 0% of all reports · about 37 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 12.4%
- marked serious by the reporter
- 27.8% across the class
- 0%
- record death among outcomes, as reported
- 0 reports · not verified by FDA
Between January 2012 and September 2021, 534 adverse event reports received by FDA list latanoprost ophthalmic solution 0.005%, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (4) are left out of every figure here.
In the 12 months to June 2026, 0 reports listed it, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 37 reports a year and 0% of the 20,646,523 reports in the database, and 1% of the reports for the prostaglandin analog class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are eye irritation (24.3%), eye pain (12.4%) and intraocular pressure increased (9.9%). A report can list several reactions, so shares add to more than 100%; 115 different terms appear across these reports. Eye irritation is recorded in 24.3% of these reports, a larger share than in the median prostaglandin analog drug (8.2%).
12.4% of the reports are marked serious by the reporter (27.8% across the class); 0% record death among the outcomes and 1.5% record hospitalisation, as reported. 84.3% of the reports came from consumers, and the largest patient age group is 75 and over (27.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
Reactions recorded in the reports
share of Latanoprost ophthalmic solution 0.005% reports recording the termmedian drug in prostaglandin analog
- Eye irritationeye irritation24.3%130
- Eye paineye pain12.4%66
- Intraocular pressure increasedraised pressure in the eye9.9%53
- Ocular hyperaemiaa red eye9%48
- Vision blurredblurred vision8.8%47
- Product quality issuea problem with the product itself7.1%38
- Drug ineffectivethe medicine did not work as expected5.6%30
- Eye pruritus5.1%27
- Dry eyedry eye4.5%24
- Lacrimation increasedwatery eyes4.1%22
- Headachehead pain3%16
- Condition aggravatedthe condition being treated got worse2.8%15
- Visual impairmentreduced vision2.8%15
- Photophobiasensitivity to light2.2%12
- Product container issuea problem with the container2.1%11
- Dizzinesslight-headedness or unsteadiness1.7%9
- Product dose omissiona dose was missed1.7%9
- Product packaging difficult to open1.7%9
- Drug dose omissiona dose was missed1.5%8
- Eye swellinga swollen eye1.5%8
- Eyelid oedemaa swollen eyelid1.5%8
- Incorrect product storagethe product was stored wrongly1.5%8
- Wrong technique in product usage processthe product was used in the wrong way1.5%8
- Coughcough1.3%7
- Erythemaskin redness1.3%7
- Eye discharge1.3%7
- No adverse eventno adverse event was reported1.3%7
- Ocular discomfort1.3%7
- Product storage errorthe product was stored wrongly1.3%7
Top 30 of 115 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 13 drugs in the prostaglandin analog class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 51,210 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Glaucoma | 285 | 53.4% |
| Intraocular pressure increased | 40 | 7.5% |
| Intraocular pressure test | 4 | 0.7% |
| Intraocular pressure test abnormal | 2 | 0.4% |
| Ocular hypertension | 2 | 0.4% |
| Open angle glaucoma | 2 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 534 reports.
In context
| Measure | Latanoprost ophthalmic solution 0.005% | Prostaglandin analog | All reports |
|---|---|---|---|
| Reports as suspect product | 534 | 51,210 | 20,646,523 |
| Share of that pool | — | 1% | 0% |
| Reports, latest 12 months | 0 | — | 1,332,454 |
| Marked serious | 12.4% | 27.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 0 | 25 | 91 |
| Hospitalisation recorded, per 1,000 reports | 15 | 45 | 213 |
| Consumer-filed share | 84.3% | 68.8% | 45.8% |
| Top term, share of reports | Eye irritation 24.3% | median 8.2% | 0.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the prostaglandin analog class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Latanoprost | generic | 12,387 | 545 | 19.8% |
| Lumigan | brand | 9,203 | 223 | 15.3% |
| Xalatan | brand | 9,038 | 25 | 76.6% |
| Latisse | brand | 8,743 | 116 | 2% |
| Travatan Z | brand | 3,937 | 108 | 22.3% |
| Zioptan | brand | 1,864 | 10 | 25.5% |
| Travoprost | generic | 1,633 | 75 | 18.2% |
| Caverject | brand | 1,198 | 10 | 42.8% |
| Bimatoprost | generic | 775 | 57 | 37% |
| Alprostadil | generic | 681 | 24 | 89.6% |
| Xelpros | brand | 610 | 8 | 18.2% |
| Rocklatan | brand | 607 | 90 | 10% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Latanoprost ophthalmic solution 0.005% reports
How many adverse event reports has FDA received for Latanoprost ophthalmic solution 0.005%?
534 reports list Latanoprost ophthalmic solution 0.005% as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 4 list it only as a concomitant medication.
What reactions are recorded in Latanoprost ophthalmic solution 0.005% reports?
eye irritation (24.3%), eye pain (12.4%), intraocular pressure increased (9.9%), ocular hyperaemia (9%) and vision blurred (8.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Latanoprost ophthalmic solution 0.005% was responsible.
How serious are the reports?
12.4% are marked serious by the reporter. Among the outcomes recorded, 0% of reports include death and 1.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (84.3%), pharmacist (9.2%) and other health professional (2.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Latanoprost ophthalmic solution 0.005% rising?
0 reports in the 12 months to June 2026, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Latanoprost ophthalmic solution 0.005% was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Latanoprost ophthalmic solution 0.005%?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Latanoprost ophthalmic solution 0.005% as a suspect or interacting product; reports listing it only as a concomitant medication (4) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.