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What the label lists and what reports show

Cenegermin side effects

Cenegermin's FDA label: “The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation.” FAERS holds 12,024 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is eye pain (5,863 reports).

  • No generic listed

Check it at the source: the cenegermin FDA label on DailyMed (effective December 31, 2024); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of OXERVATE?

The most common side effects of OXERVATE are eye pain, enlarged blood vessels in the white of the eyes (ocular hyperemia), swelling (inflammation) of the eye, and increase of tears (increased lacrimation). Tell your doctor if you have any side effects that bother you. These are not all the possible side effects of OXERVATE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Source: FDA drug label, Domp farmaceutici S.p.A., effective December 31, 2024 (SPL set 89e4bfec-d710-40ed-8885-5d13ba46b1cd), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation.

From the label: adverse reactions, continued

The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dompé U.S. Inc. at 1-833-366-7387 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In two clinical trials of patients with neurotrophic keratitis, a total of 101 patients received cenegermin-bkbj eye drops at 20 mcg/mL at a frequency of 6 times daily in the affected eye(s) for a duration of 8 weeks. The mean age of the population was 61 to 65 years of age (18 to 95). The majority of the treated patients were female (61%). The most common adverse reaction was eye pain following instillation which was reported in approximately 16% of patients. Eye pain may arise as corneal healing occurs. Other adverse reactions occurring in 1% to 10% of OXERVATE patients included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing, and headache. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of OXERVATE. …

Source: FDA drug label, Domp farmaceutici S.p.A., effective December 31, 2024 (SPL set 89e4bfec-d710-40ed-8885-5d13ba46b1cd), via openFDA; the full label on DailyMed

What do FAERS reports show?

12,024 reports list cenegermin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 211 are coded as a death and 780 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (3,179, against a median of 661 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 18 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Eye Pain (named in the label)5,863
  • Eye Irritation (named in the label)1,879
  • Product Dose Omission Issue (a use or a product term, not a reaction)1,349
  • Ocular Hyperaemia (named in the label)1,231
  • Photophobia (named in the label)1,068
  • Vision Blurred951
  • Wrong Technique In Product Usage Process (a use or a product term, not a reaction)903
  • Eye Swelling849
  • Ocular Discomfort800
  • Lacrimation Increased738
  • Eyelid Pain707
  • Headache (named in the label)675
  • Product Administration Error616
  • Dry Eye544
  • Off Label Use (a use or a product term, not a reaction)527
  • Drug Ineffective (a use or a product term, not a reaction)500
  • Foreign Body Sensation In Eyes490
  • Therapy Interrupted (a use or a product term, not a reaction)488
  • Periorbital Pain479
  • Intentional Product Misuse (a use or a product term, not a reaction)349
  • Eye Discharge315
  • Accidental Overdose (a use or a product term, not a reaction)294
  • Visual Impairment280
  • Device Use Issue278
  • Swelling Of Eyelid255

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Cenegermin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions