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What the label lists and what reports show

Carteolol side effects

Carteolol's FDA label lists its adverse reactions in its own words. FAERS holds 330 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 intraocular pressure increased (18 reports).

  • Generic listed

Check it at the source: the carteolol FDA label on DailyMed (effective August 31, 2021, Sandoz Inc); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following adverse reactions have been reported in clinical trials with Carteolol Hydrochloride Ophthalmic Solution. Ocular: Transient eye irritation, burning, tearing, conjunctival hyperemia and edema occurred in about 1 of 4 patients. Ocular symptoms including blurred and cloudy vision, photophobia, decreased night vision, and ptosis and ocular signs including blepharoconjunctivitis, abnormal corneal staining, and corneal sensitivity occurred occasionally. Systemic: As is characteristic of nonselective adrenergic blocking agents, Carteolol may cause bradycardia and decreased blood pressure (See WARNINGS ). The following systemic events have occasionally been reported with the use of Carteolol Hydrochloride Ophthalmic Solution: cardiac arrhythmia, heart palpitation, dyspnea, asthenia, headache, dizziness, insomnia, sinusitis, and taste perversion. …

Source: FDA drug label, Sandoz Inc, effective August 31, 2021 (SPL set 571fe550-399d-4296-835c-37aa1ab9b409), via openFDA; the full label on DailyMed

What do FAERS reports show?

330 reports list carteolol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 27 are coded as a death and 149 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, 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

  • Intraocular Pressure Increased18
  • Cataract14
  • Drug Ineffective (a use or a product term, not a reaction)14
  • Malaise13
  • Bradycardia (named in the label)11
  • Eye Pain11
  • Off Label Use (a use or a product term, not a reaction)11
  • Visual Acuity Reduced11
  • Diarrhoea9
  • Anaemia8
  • Dizziness (named in the label)8
  • Nausea (named in the label)8
  • Asthenia (named in the label)7
  • Blood Creatine Phosphokinase Increased7
  • Condition Aggravated (a use or a product term, not a reaction)7
  • Decreased Appetite7
  • Fall7
  • Muscular Weakness7
  • Pyrexia7
  • Atrial Fibrillation6
  • Death (an outcome recorded in the report)6
  • Disseminated Intravascular Coagulation6
  • Glaucoma (a use or a product term, not a reaction)6
  • Hypertension (a use or a product term, not a reaction)6
  • Liver Disorder6

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

What next?

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