CENEGERMIN-BKBJ: 11,919 Adverse Event Reports & Safety Profile
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11,919
Total FAERS Reports
199 (1.7%)
Deaths Reported
736
Hospitalizations
11,919
As Primary/Secondary Suspect
2
Life-Threatening
1
Disabilities
Prescription
Status
FDA Application: 761094 ·
First Report: 2014 · Latest Report: 20250905
What Are the Most Common CENEGERMIN-BKBJ Side Effects?
#1 Most Reported
Eye pain
5,847 reports (49.1%)
#2 Most Reported
Eye irritation
1,871 reports (15.7%)
#3 Most Reported
Product dose omission issue
1,335 reports (11.2%)
All CENEGERMIN-BKBJ Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Eye pain | 5,847 | 49.1% | 16 | 135 |
| Eye irritation | 1,871 | 15.7% | 5 | 46 |
| Product dose omission issue | 1,335 | 11.2% | 9 | 125 |
| Ocular hyperaemia | 1,226 | 10.3% | 4 | 32 |
| Photophobia | 1,065 | 8.9% | 1 | 18 |
| Vision blurred | 944 | 7.9% | 4 | 35 |
| Wrong technique in product usage process | 899 | 7.5% | 4 | 48 |
| Eye swelling | 847 | 7.1% | 3 | 16 |
| Ocular discomfort | 797 | 6.7% | 2 | 23 |
| Lacrimation increased | 737 | 6.2% | 3 | 13 |
| Eyelid pain | 707 | 5.9% | 1 | 18 |
| Headache | 673 | 5.7% | 1 | 13 |
| Product administration error | 613 | 5.1% | 1 | 41 |
| Dry eye | 537 | 4.5% | 1 | 15 |
| Off label use | 521 | 4.4% | 3 | 16 |
| Drug ineffective | 497 | 4.2% | 1 | 11 |
| Foreign body sensation in eyes | 488 | 4.1% | 1 | 8 |
| Therapy interrupted | 488 | 4.1% | 3 | 48 |
| Periorbital pain | 476 | 4.0% | 1 | 10 |
| Intentional product misuse | 346 | 2.9% | 0 | 19 |
Who Reports CENEGERMIN-BKBJ Side Effects? Age & Gender Data
Gender: 70.3% female, 29.7% male. Average age: 68.5 years. Most reports from: US. View detailed demographics →
Is CENEGERMIN-BKBJ Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 0 |
| 2018 | 2 | 0 | 0 |
| 2019 | 138 | 11 | 18 |
| 2020 | 262 | 29 | 28 |
| 2021 | 337 | 8 | 47 |
| 2022 | 645 | 21 | 56 |
| 2023 | 937 | 27 | 87 |
| 2024 | 792 | 35 | 87 |
| 2025 | 362 | 18 | 55 |
What Is CENEGERMIN-BKBJ Used For?
| Indication | Reports |
|---|---|
| Neurotrophic keratopathy | 10,333 |
| Hypoaesthesia eye | 1,206 |
| Ulcerative keratitis | 948 |
| Product used for unknown indication | 642 |
| Keratitis | 242 |
| Dry eye | 123 |
| Corneal disorder | 70 |
| Punctate keratitis | 64 |
| Illness | 46 |
| Ophthalmic herpes zoster | 36 |
CENEGERMIN-BKBJ vs Alternatives: Which Is Safer?
CENEGERMIN-BKBJ vs CENOBAMATE
CENEGERMIN-BKBJ vs CEPHALEXIN
CENEGERMIN-BKBJ vs CERITINIB
CENEGERMIN-BKBJ vs CERLIPONASE ALFA
CENEGERMIN-BKBJ vs CERTICAN
CENEGERMIN-BKBJ vs CERTOLIZUMAB
CENEGERMIN-BKBJ vs CERTOLIZUMAB PEGOL
CENEGERMIN-BKBJ vs CERTOPARIN
CENEGERMIN-BKBJ vs CETIRIZINE
CENEGERMIN-BKBJ vs CETIRIZINE\PSEUDOEPHEDRINE
Official FDA Label for CENEGERMIN-BKBJ
Official prescribing information from the FDA-approved drug label.