Drug · FAERS side-effect profile with label screen
Cenegermin-Bkbj side effects: what 12,024 FDA adverse event reports show
Drug class
Recombinant Human Nerve Growth Factor
FDA label (Established Pharmacologic Class)
Brand names
Oxervate
openFDA label
Who reports
12,024 reports · 12% serious · 211 with death outcome · 70% female
openFDA FAERS counts, all years, deduplication not applied
Used for
OXERVATE ® (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis. OXERVATE is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis. ( 1 )
FDA label, Indications and Usage
What it is
OXERVATE ophthalmic solution contains cenegermin-bkbj, a recombinant form of human nerve growth factor produced in Escherichia coli . Cenegermin-bkbj contains 118 amino acids. Cenegermin-bkbj has a relative molecular mass of 13,266 Daltons and the following molecular formula: C 583 H 908 N 166 O 173 S 8 .
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 6Labeled (related wording) 6Reporting / coding artifact 1Not in label — unassessed 27
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 414 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Blepharorrhaphy | 12 | 10,319.7 2,309.9–46,105.0ROR 10,330.0 · χ² 16,243 / p <1e-300 | 438.9 EB05 267.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Periorbital pain | 479 | 2,632.1 2,285.2–3,031.7ROR 2,741.3 · χ² 496,867 / p <1e-300 | 998.9 EB05 926.1 · IC025 +8.8 3/3 methods agree | Not in label — unassessed | serious n=25 · 92% consumer | no trial data cached |
| Eyelid pain | 707 | 1,006.6 919.0–1,102.6ROR 1,069.4 · χ² 447,453 / p <1e-300 | 624.5 EB05 586.9 · IC025 +8.7 3/3 methods agree | Labeled (related wording) related wording | serious n=29 · 93% consumer | no trial data cached |
| Periorbital discomfort | 10 | 358.3 181.3–708.1ROR 358.6 · χ² 2,660 / p <1e-300 | 189.8 EB05 110.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Persistent corneal epithelial defect | 16 | 283.7 167.2–481.3ROR 284.1 · χ² 3,630 / p <1e-300 | 189.0 EB05 123.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Eye pain | 5,863 | 207.3 203.2–211.6ROR 403.7 · χ² 1,077,016 / p <1e-300 | 185.0 EB05 181.1 · IC025 +7.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 105.6 · 91% consumer | no trial data cached |
| Corneal deposits | 71 | 186.2 145.8–237.6ROR 187.3 · χ² 11,632 / p <1e-300 | 160.9 EB05 131.8 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=13 | no trial data cached |
| Corneal neovascularisation | 19 | 154.1 96.4–246.4ROR 154.4 · χ² 2,514 / p <1e-300 | 124.2 EB05 84.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Foreign body sensation in eyes | 490 | 148.6 135.7–162.7ROR 154.9 · χ² 66,013 / p <1e-300 | 136.2 EB05 126.3 · IC025 +6.8 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · 92% consumer | no trial data cached |
| Ocular discomfort | 800 | 138.7 129.4–148.8ROR 148.6 · χ² 101,152 / p <1e-300 | 128.1 EB05 120.8 · IC025 +6.8 3/3 methods agree | Labeled (related wording) related wording | serious n=47 · 89% consumer | no trial data cached |
| Corneal transplant | 56 | 137.0 104.4–179.8ROR 137.6 · χ² 6,878 / p <1e-300 | 121.8 EB05 97.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=27 · 76% consumer | no trial data cached |
| Eyelid irritation | 166 | 126.2 107.9–147.6ROR 127.9 · χ² 19,090 / p <1e-300 | 116.1 EB05 102.0 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=7 · 90% consumer | no trial data cached |
| Eye ulcer | 36 | 117.7 84.0–164.9ROR 118.1 · χ² 3,791 / p <1e-300 | 104.3 EB05 78.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=3 · 71% consumer | no trial data cached |
| Eye infection bacterial | 32 | 106.5 74.5–152.1ROR 106.7 · χ² 3,050 / p <1e-300 | 94.8 EB05 70.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=32 | no trial data cached |
| Photophobia (light sensitivity) | 1,068 | 105.8 99.7–112.3ROR 116.0 · χ² 104,461 / p <1e-300 | 99.6 EB05 94.7 · IC025 +6.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.3 · 90% consumer | no trial data cached |
| Eye infection viral | 18 | 103.5 64.4–166.6ROR 103.7 · χ² 1,629 / p <1e-300 | 88.8 EB05 59.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Treatment delayed | 89 | 101.6 82.1–125.7ROR 102.3 · χ² 8,275 / p <1e-300 | 94.1 EB05 78.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=5 · 93% consumer | no trial data cached |
| Superficial injury of eye | 51 | 87.2 65.9–115.5ROR 87.6 · χ² 4,054 / p <1e-300 | 80.6 EB05 63.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=1 · 92% consumer | no trial data cached |
| Eye infection fungal | 18 | 87.0 54.2–139.6ROR 87.1 · χ² 1,375 / p <1e-300 | 76.4 EB05 51.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Corneal scar | 21 | 77.0 49.8–119.2ROR 77.1 · χ² 1,436 / p <1e-300 | 69.3 EB05 47.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=3 · ♀ 48% (drug 70%) | no trial data cached |
| Swelling of eyelid | 255 | 76.1 67.2–86.1ROR 77.7 · χ² 18,023 / p <1e-300 | 72.5 EB05 65.3 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=20 · 87% consumer | no trial data cached |
| Periorbital irritation | 11 | 62.0 34.0–113.2ROR 62.1 · χ² 580 / p 2e-128 | 54.6 EB05 32.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Corneal perforation | 21 | 61.0 39.5–94.2ROR 61.1 · χ² 1,140 / p 4e-250 | 56.1 EB05 38.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Eye irritation | 1,879 | 60.8 58.3–63.5ROR 71.9 · χ² 107,002 / p <1e-300 | 58.7 EB05 56.5 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 82.2 · 90% consumer | no trial data cached |
| Product administration error | 616 | 55.5 51.3–60.0ROR 58.5 · χ² 31,929 / p <1e-300 | 53.7 EB05 50.3 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 60.8 · 92% consumer | no trial data cached |
| Eyelid margin crusting | 87 | 55.5 44.9–68.7ROR 55.9 · χ² 4,460 / p <1e-300 | 53.2 EB05 44.5 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=6 · 94% consumer | no trial data cached |
| Eye discharge | 315 | 55.5 49.6–62.0ROR 56.9 · χ² 16,276 / p <1e-300 | 53.6 EB05 48.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=26 · 87% consumer | no trial data cached |
| Corneal abrasion | 37 | 48.6 35.1–67.3ROR 48.7 · χ² 1,631 / p <1e-300 | 46.2 EB05 35.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=3 · 84% consumer | no trial data cached |
| Ocular hyperaemia | 1,231 | 47.2 44.7–49.8ROR 52.4 · χ² 54,236 / p <1e-300 | 45.9 EB05 43.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 39.6 · 88% consumer | no trial data cached |
| Periorbital swelling | 144 | 47.0 39.9–55.4ROR 47.5 · χ² 6,266 / p <1e-300 | 45.5 EB05 39.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=10 · 95% consumer | no trial data cached |
| Lacrimation increased | 738 | 44.2 41.1–47.4ROR 47.0 · χ² 30,348 / p <1e-300 | 43.0 EB05 40.5 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.8 · 92% consumer | no trial data cached |
| Eye swelling | 849 | 41.0 38.4–43.8ROR 44.0 · χ² 32,357 / p <1e-300 | 40.0 EB05 37.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.2 · 91% consumer | no trial data cached |
| Asthenopia | 124 | 40.7 34.1–48.5ROR 41.1 · χ² 4,649 / p <1e-300 | 39.5 EB05 34.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=3 · 97% consumer | no trial data cached |
| Hypoaesthesia eye | 13 | 39.6 22.8–68.6ROR 39.6 · χ² 441 / p 4e-98 | 36.8 EB05 22.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Erythema of eyelid | 117 | 39.0 32.5–46.8ROR 39.4 · χ² 4,201 / p <1e-300 | 37.9 EB05 32.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=10 · 90% consumer | no trial data cached |
| Eye inflammation | 191 | 36.0 31.3–41.5ROR 36.6 · χ² 6,339 / p <1e-300 | 35.2 EB05 31.2 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=16 · 89% consumer | no trial data cached |
| Abnormal sensation in eye | 86 | 35.8 28.9–44.3ROR 36.1 · χ² 2,817 / p <1e-300 | 34.9 EB05 29.1 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=4 · 93% consumer | no trial data cached |
| Ophthalmic herpes simplex | 10 | 30.9 16.6–57.8ROR 31.0 · χ² 256 / p 7e-58 | 28.8 EB05 16.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Eye infection | 188 | 29.7 25.8–34.3ROR 30.2 · χ² 5,104 / p <1e-300 | 29.2 EB05 25.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=9 · 80% consumer | no trial data cached |
| Rhinalgia | 45 | 29.2 21.7–39.2ROR 29.3 · χ² 1,177 / p 3e-258 | 28.4 EB05 22.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | 91% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Eye pain | 5,863 | 207.3 203.2–211.6ROR 403.7 · χ² 1,077,016 / p <1e-300 | 185.0 EB05 181.1 · IC025 +7.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 105.6 · 91% consumer | no trial data cached |
| Eye irritation | 1,879 | 60.8 58.3–63.5ROR 71.9 · χ² 107,002 / p <1e-300 | 58.7 EB05 56.5 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 82.2 · 90% consumer | no trial data cached |
| Product dose omission issue | 1,349 | 8.3 7.9–8.7ROR 9.2 · χ² 8,728 / p <1e-300 | 8.2 EB05 7.9 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 20.9 · 90% consumer | no trial data cached |
| Ocular hyperaemia | 1,231 | 47.2 44.7–49.8ROR 52.4 · χ² 54,236 / p <1e-300 | 45.9 EB05 43.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 39.6 · 88% consumer | no trial data cached |
| Photophobia (light sensitivity) | 1,068 | 105.8 99.7–112.3ROR 116.0 · χ² 104,461 / p <1e-300 | 99.6 EB05 94.7 · IC025 +6.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.3 · 90% consumer | no trial data cached |
| Vision blurred (blurred vision) | 951 | 12.2 11.5–13.0ROR 13.2 · χ² 9,780 / p <1e-300 | 12.1 EB05 11.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · 89% consumer | no trial data cached |
| Wrong technique in product usage process | 903 | 7.8 7.4–8.3ROR 8.4 · χ² 5,399 / p <1e-300 | 7.8 EB05 7.4 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 18.1 · 94% consumer | no trial data cached |
| Eye swelling | 849 | 41.0 38.4–43.8ROR 44.0 · χ² 32,357 / p <1e-300 | 40.0 EB05 37.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.2 · 91% consumer | no trial data cached |
| Ocular discomfort | 800 | 138.7 129.4–148.8ROR 148.6 · χ² 101,152 / p <1e-300 | 128.1 EB05 120.8 · IC025 +6.8 3/3 methods agree | Labeled (related wording) related wording | serious n=47 · 89% consumer | no trial data cached |
| Lacrimation increased | 738 | 44.2 41.1–47.4ROR 47.0 · χ² 30,348 / p <1e-300 | 43.0 EB05 40.5 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.8 · 92% consumer | no trial data cached |
| Eyelid pain | 707 | 1,006.6 919.0–1,102.6ROR 1,069.4 · χ² 447,453 / p <1e-300 | 624.5 EB05 586.9 · IC025 +8.7 3/3 methods agree | Labeled (related wording) related wording | serious n=29 · 93% consumer | no trial data cached |
| Headache | 675 | 1.9 1.7–2.0ROR 1.9 · χ² 286 / p 2e-64 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.2 · 90% consumer | no trial data cached |
| Product administration error | 616 | 55.5 51.3–60.0ROR 58.5 · χ² 31,929 / p <1e-300 | 53.7 EB05 50.3 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 60.8 · 92% consumer | no trial data cached |
| Dry eye | 544 | 19.8 18.2–21.5ROR 20.7 · χ² 9,600 / p <1e-300 | 19.6 EB05 18.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 · 93% consumer | no trial data cached |
| Off label use (used outside approved label) | 527 | 1.1 1.0–1.2ROR 1.1 · χ² 2 / p 0.093 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Periorbital pain — n=479, PRR 2,632.1
- Corneal transplant — n=56, PRR 137.0
- Eye ulcer — n=36, PRR 117.7
- Eye infection bacterial — n=32, PRR 106.5
- Treatment delayed — n=89, PRR 101.6
- Superficial injury of eye — n=51, PRR 87.2
- Corneal scar — n=21, PRR 77.0
- Swelling of eyelid — n=255, PRR 76.1
- Corneal perforation — n=21, PRR 61.0
- Eye discharge — n=315, PRR 55.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Cenegermin-Bkbj?
In FDA FAERS, the most frequently co-reported reaction terms for Cenegermin-Bkbj are eye pain, eye irritation, ocular hyperaemia, photophobia, vision blurred, eye swelling. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Cenegermin-Bkbj have an FDA boxed warning?
No. The FDA label retrieved for Cenegermin-Bkbj has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cenegermin-Bkbj causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 89e4bfec-d710-40ed-8885-5d13ba46b1cd, effective 20241231; matched on
openfda.generic_name.exact:"CENEGERMIN-BKBJ") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 454 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.