Skip to main content
PlainMeds

What the label lists and what reports show

Acetazolamide side effects

Acetazolamide's FDA label lists its adverse reactions in its own words. FAERS holds 6,032 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 headache (287 reports).

  • Generic listed

Check it at the source: the acetazolamide FDA label on DailyMed (effective August 19, 2026, Strides Pharma Science Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Body as a whole: Headache, malaise, fatigue, fever, flushing, growth retardation in children, flaccid paralysis, anaphylaxis Digestive: Gastrointestinal disturbances such as nausea, vomiting, diarrhea Hematological/Lymphatic: Blood dyscrasias such as aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, thrombocytopenic purpura, melena Hepato-biliary disorders: Abnormal liver function, cholestatic jaundice, hepatic insufficiency, fulminant hepatic necrosis Metabolic/Nutritional: Metabolic acidosis, electrolyte imbalance, including hypokalemia, hyponatremia, osteomalacia with long-term phenytoin therapy, loss of appetite, taste alteration, hyper/hypoglycemia Nervous: Drowsiness, paraesthesia (including numbness and tingling of extremities and face), depression, excitement, ataxia, confusion, convulsions, dizziness Skin: Allergic skin reactions including urticaria …

Source: FDA drug label, Strides Pharma Science Limited, effective August 19, 2026 (SPL set 4813b9dd-5f58-44bb-ad64-cdb331828080), via openFDA; the full label on DailyMed

What do FAERS reports show?

6,032 reports list acetazolamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 468 are coded as a death and 2,146 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, 9 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

  • Off Label Use (a use or a product term, not a reaction)724
  • Drug Ineffective (a use or a product term, not a reaction)693
  • Condition Aggravated (a use or a product term, not a reaction)301
  • Headache (named in the label)287
  • Fatigue (named in the label)256
  • Dyspnoea253
  • Nausea (named in the label)251
  • Metabolic Acidosis (named in the label)208
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)205
  • Diarrhoea (named in the label)179
  • Vomiting (named in the label)172
  • Pain160
  • Dizziness (named in the label)158
  • Intraocular Pressure Increased151
  • Acute Kidney Injury146
  • Somnolence143
  • Drug Ineffective For Unapproved Indication (a use or a product term, not a reaction)141
  • Hypokalaemia (named in the label)129
  • Drug Interaction (a use or a product term, not a reaction)125
  • Arthralgia124
  • Pyrexia121
  • Anxiety120
  • Fall120
  • Paraesthesia (named in the label)119
  • Asthenia118

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

What next?

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