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What the label lists and what reports show

Ethambutol side effects

Ethambutol's FDA label lists its adverse reactions in its own words. FAERS holds 2,668 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 pyrexia (164 reports).

  • Generic listed

Check it at the source: the ethambutol FDA label on DailyMed (effective November 21, 2025, Kanchan Healthcare Inc); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

ETHAMBUTOL HCl may produce decreases in visual acuity, including irreversible blindness, which appear to be due to optic neuritis. Optic neuropathy including optic neuritis or retrobulbar neuritis occurring in association with ethambutol therapy may be characterized by one or more of the following events: decreased visual acuity, scotoma, color blindness, and/or visual defect. These events have also been reported in the absence of a diagnosis of optic or retrobulbar neuritis. Patients should be advised to report promptly to their physician any change of visual acuity. The change in visual acuity may be unilateral or bilateral and hence each eye must be tested separately and both eyes tested together. …

Source: FDA drug label, Kanchan Healthcare Inc, effective November 21, 2025 (SPL set e4ccab0e-84ff-447f-82ca-fa0a3989f6b7), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,668 reports list ethambutol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 331 are coded as a death and 1,090 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, 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

  • Product Use In Unapproved Indication (a use or a product term, not a reaction)213
  • Pyrexia164
  • Nausea (named in the label)132
  • Vomiting (named in the label)123
  • Drug Interaction (a use or a product term, not a reaction)114
  • Drug Intolerance105
  • Cough94
  • Dyspnoea93
  • Off Label Use (a use or a product term, not a reaction)89
  • Diarrhoea88
  • Immune Reconstitution Syndrome86
  • Mycobacterium Avium Complex Infection83
  • Anaemia80
  • Pneumonia78
  • Drug Ineffective For Unapproved Indication (a use or a product term, not a reaction)74
  • Condition Aggravated (a use or a product term, not a reaction)71
  • Fatigue68
  • Headache (named in the label)67
  • Drug Ineffective (a use or a product term, not a reaction)66
  • Weight Decreased66
  • Rash (named in the label)65
  • Neutropenia (named in the label)64
  • Decreased Appetite63
  • Paradoxical Drug Reaction62
  • Asthenia60

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

What next?

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