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What the label lists and what reports show

Nepafenac side effects

Nepafenac's FDA label: “Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation.” FAERS holds 3,181 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 (455 reports).

  • No generic listed

Check it at the source: the nepafenac FDA label on DailyMed (effective April 1, 2026, Harrow Eye, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation.

From the label: adverse reactions, continued

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 the rates in the clinical studies of another drug and may not reflect the rates observed in practice. Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow Eye, LLC at 1-833-4HARROW or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Serious and Otherwise Important Adverse Reactions The following adverse reactions are discussed in greater detail in other sections of labeling. Increased Bleeding Time [see Warnings and Precautions (5.1) ] Delayed Healing [see Warnings and Precautions (5.2) ] Corneal Effects [see Warnings and Precautions (5.3) ] 6.2 Ocular Adverse Reactions The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure (IOP), and sticky sensation. These reactions occurred in approximately 5% to 10% of patients. …

Source: FDA drug label, Harrow Eye, LLC, effective April 1, 2026 (SPL set 10f411d3-a81e-074a-e063-6294a90ab547), via openFDA; the full label on DailyMed

What do FAERS reports show?

3,181 reports list nepafenac among the medicines taken, each a report of something that happened, not proof the medicine caused it; 74 are coded as a death and 375 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. Of the 19 reactions below, 3 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 Pain455
  • Drug Ineffective (a use or a product term, not a reaction)329
  • Treatment Failure (a use or a product term, not a reaction)230
  • Vision Blurred213
  • Off Label Use (a use or a product term, not a reaction)146
  • Cataract (a use or a product term, not a reaction)129
  • Visual Impairment124
  • Eye Irritation107
  • Fatigue103
  • Visual Acuity Reduced93
  • Nausea (named in the label)83
  • Headache (named in the label)81
  • Chronic Kidney Disease72
  • Macular Oedema69
  • Ocular Hyperaemia (named in the label)69
  • Ulcerative Keratitis67
  • Dizziness66
  • Product Quality Issue (a use or a product term, not a reaction)66
  • Intraocular Pressure Increased64
  • Dyspnoea61
  • Cystoid Macular Oedema58
  • Diarrhoea58
  • Pain (a use or a product term, not a reaction)57
  • Liquid Product Physical Issue55
  • Renal Failure55

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

What next?

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