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What the label lists and what reports show

Gatifloxacin side effects

Gatifloxacin's FDA label: “Most common adverse reactions occurring in ≥ 1 % of patients included worsening of conjunctivitis, eye irritation, dysgeusia, and eye pain.” FAERS holds 1,776 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 hypoglycaemia (151 reports).

  • Generic listed

Check it at the source: the gatifloxacin FDA label on DailyMed (effective September 8, 2016, Allergan, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions occurring in ≥ 1 % of patients included worsening of conjunctivitis, eye irritation, dysgeusia, and eye pain.

From the label: adverse reactions, continued

The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ] Growth of Resistant Organisms With Prolonged Use [ see Warnings and Precautions ( 5.2 ) ] Corneal Endothelial Cell Injury [ see Warnings and Precautions ( 5.3 ) ] Most common adverse reactions occurring in ≥ 1 % of patients included worsening of conjunctivitis, eye irritation, dysgeusia, and eye pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6. 1 Clinical Studies 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 clinical studies of patients with bacterial conjunctivitis treated with ZYMAXID ® (N=717), the most frequently reported adverse reactions occurring in ≥ 1 % of patients were: worsening of the conjunctivitis, eye irritation, dysgeusia, and eye pain.

Source: FDA drug label, NDA022548 (Abbvie), as published by Allergan, Inc., effective September 8, 2016 (SPL set 1160b16c-929a-4e85-9c0b-1d8c96a7678b), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,776 reports list gatifloxacin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 105 are coded as a death and 687 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 23 reactions below, 7 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

  • Hypoglycaemia151
  • Hyperglycaemia96
  • Anaphylactic Reaction (named in the label)85
  • Drug Intolerance83
  • Drug Ineffective (a use or a product term, not a reaction)79
  • Diarrhoea71
  • Eye Pain (named in the label)67
  • Dizziness59
  • Off Label Use (a use or a product term, not a reaction)56
  • Dyspnoea (named in the label)55
  • Rash (named in the label)55
  • Nausea (named in the label)50
  • Chronic Kidney Disease47
  • Renal Failure47
  • Blood Glucose Increased46
  • Cataract44
  • Intraocular Pressure Increased44
  • Visual Acuity Reduced43
  • Eye Irritation (named in the label)42
  • Vision Blurred (named in the label)42
  • Vomiting39
  • Fatigue38
  • Acute Kidney Injury37
  • Drug Hypersensitivity36
  • Endophthalmitis36

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

What next?

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