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What the label lists and what reports show

Apraclonidine side effects

Apraclonidine's FDA label lists its adverse reactions in its own words. FAERS holds 106 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 somnolence (7 reports).

  • No generic listed

Check it at the source: the apraclonidine FDA label on DailyMed (effective May 8, 2026, Harrow Eye, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following adverse events, occurring in less than 2% of patients, were reported in association with the use of IOPIDINE 1% Ophthalmic Solution in laser surgery: ocular injection, upper lid elevation, irregular heart rate, nasal decongestion, ocular inflammation, conjunctival blanching, and mydriasis. The following adverse events were observed in investigational studies dosing IOPIDINE 1% Ophthalmic Solution once or twice daily for up to 28 days in non‑laser studies: Ocular Conjunctival blanching, upper lid elevation, mydriasis, burning, discomfort, foreign body sensation, dryness, itching, hypotony, blurred or dimmed vision, allergic response, conjunctival microhemorrhage. …

Source: FDA drug label, Harrow Eye, LLC, effective May 8, 2026 (SPL set 00f18845-ccde-8678-e063-6294a90a3374), via openFDA; the full label on DailyMed

What do FAERS reports show?

106 reports list apraclonidine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 30 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 21 reactions below, 4 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.

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)21
  • Off Label Use (a use or a product term, not a reaction)7
  • Somnolence (named in the label)7
  • Eyelid Ptosis6
  • Vision Blurred6
  • Constipation5
  • Dry Mouth (named in the label)5
  • Dyspnoea5
  • Eye Pain5
  • Sinus Bradycardia5
  • Tenderness5
  • Urinary Retention5
  • Visual Acuity Reduced5
  • Acute Kidney Injury4
  • Angle Closure Glaucoma4
  • Anuria4
  • Bradycardia (named in the label)4
  • Choroidal Effusion4
  • Crystalluria4
  • Eye Irritation4
  • Headache (named in the label)4
  • Ocular Hyperaemia4
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)4
  • Retinal Pigment Epitheliopathy4
  • Condition Aggravated (a use or a product term, not a reaction)3

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

What next?

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