Prostaglandin Analog side effects compared: 8 drugs, 98,127 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Latanoprost | 50,007 | 55% | 3,179 | – | Foreign body sensation in eyes; Growth of eyelashes; Corneal disorder | Eye irritation; Hypopnoea |
| Bimatoprost | 28,647 | 27% | 793 | – | Madarosis; Erythema of eyelid; Eyelids pruritus | Ocular hyperaemia; Blepharal pigmentation |
| Travoprost (Travoprost Ophthalmic Soluton) | 8,599 | 37% | 330 | – | Ocular discomfort; Foreign body sensation in eyes; Blepharitis | Ocular hyperaemia; Eye irritation |
| Alprostadil (Caverject Impulse) | 3,590 | 65% | 272 | – | Haemoglobin decreased; Cardiac failure; Needle issue | Drug reaction with eosinophilia and systemic symptoms; Hypokalaemia |
| Travoprost (Isomer Free) (Travoprost) | 3,160 | 47% | 109 | – | Eye pain; Eye pruritus; Dry eye | Eye irritation; Hypersensitivity |
| Tafluprost | 2,905 | 35% | 330 | – | Eye irritation; Eye pain; Eye pruritus | Ocular hyperaemia; Eye swelling |
| Dinoprostone (Cervidil) | 799 | 86% | 50 | – | Disseminated intravascular coagulation | Caesarean section; Premature baby |
| Tafluprost Opthalmic (Tafluprost) | 420 | 79% | 19 | – | Eye irritation | – |
Class-wide signals (flagged in at least 4 of 8 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Glaucoma | 5/8 | 31.9 | 1,729 | 0/5 members' labels |
| Eye irritation | 5/8 | 17.6 | 3,299 | 2/5 members' labels |
| Ocular hyperaemia | 4/8 | 32.4 | 3,392 | 0/4 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Eyelash changes | Bimatoprost | 63 | 428.7 | Labeled (related wording) |
| Eyelash discolouration | Bimatoprost | 56 | 247.8 | Likely indication confounding |
| Scleral hyperaemia | Bimatoprost | 134 | 177.3 | Not in label — unassessed |
| Erythema of eyelid | Bimatoprost | 1,014 | 171.6 | Labeled (related wording) |
| Trichiasis | Bimatoprost | 55 | 158.7 | Labeled adverse reaction |
| Lid sulcus deepened | Bimatoprost | 64 | 152.3 | Not in label — unassessed |
| Madarosis | Bimatoprost | 1,393 | 98.9 | Labeled adverse reaction |
| Eyelid exfoliation | Bimatoprost | 91 | 95.8 | Labeled (related wording) |
| Steroid dependence | Latanoprost | 139 | 81.9 | Not in label — unassessed |
| Trichorrhexis | Bimatoprost | 281 | 81.9 | Labeled adverse reaction |
| Catarrh | Latanoprost | 138 | 77.0 | Not in label — unassessed |
| Eyelid rash | Bimatoprost | 59 | 48.8 | Labeled (related wording) |
| Skin hyperpigmentation | Bimatoprost | 481 | 43.5 | Labeled adverse reaction |
| Eyelid skin dryness | Bimatoprost | 63 | 41.6 | Labeled (related wording) |
| Burns second degree | Latanoprost | 147 | 38.4 | Not in label — unassessed |
| Erectile dysfunction | Alprostadil | 93 | 21.2 | Likely indication confounding |
| Corneal disorder | Latanoprost | 99 | 20.0 | Labeled (related wording) |
| Hypopnoea | Latanoprost | 152 | 19.2 | Not in label — unassessed |
| Corneal oedema | Latanoprost | 83 | 16.1 | Labeled adverse reaction |
| Alcohol poisoning | Latanoprost | 95 | 15.5 | Not in label — unassessed |
| Eyelid disorder | Latanoprost | 80 | 15.1 | Labeled (related wording) |
| Vision blurred | Tafluprost | 174 | 9.2 | Labeled adverse reaction |
| Rhinorrhoea | Travoprost (Isomer Free) | 60 | 6.2 | Not in label — unassessed |
| Wheezing | Travoprost (Isomer Free) | 51 | 5.7 | Not in label — unassessed |
| Cardiac failure | Alprostadil | 73 | 5.3 | Labeled (related wording) |
Common questions
Which prostaglandin analog has the most FDA adverse event reports?
Latanoprost has the most FAERS co-reports in this class (50,007), followed by Bimatoprost (28,647). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across prostaglandin analog drugs?
Reaction terms flagged in at least half of the 8 members include glaucoma, eye irritation, ocular hyperaemia. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.