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What the label lists and what reports show

Aminocaproic acid side effects

Aminocaproic acid's FDA label lists its adverse reactions in its own words. FAERS holds 765 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 haemorrhage (129 reports).

  • Generic listed

Check it at the source: the aminocaproic acid FDA label on DailyMed (effective January 8, 2024, Hikma Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Aminocaproic acid is generally well tolerated. The following adverse experiences have been reported: General: Edema, headache, malaise. Hypersensitivity Reactions: Allergic and anaphylactoid reactions, anaphylaxis. Cardiovascular: Bradycardia, hypotension, peripheral ischemia, thrombosis. Gastrointestinal: Abdominal pain, diarrhea, nausea, vomiting. Hematologic: Agranulocytosis, coagulation disorder, leukopenia, thrombocytopenia. Musculoskeletal: CPK increased, muscle weakness, myalgia, myopathy (see WARNINGS ), myositis, rhabdomyolysis. Neurologic: Confusion, convulsions, delirium, dizziness, hallucinations, intracranial hypertension, stroke, syncope. Respiratory: Dyspnea, nasal congestion, pulmonary embolism. Skin: Pruritis, rash. Special Senses: Tinnitus, vision decreased, watery eyes. Urogenital: BUN increased, renal failure. …

Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective January 8, 2024 (SPL set 7b8f0ddb-00fd-4c22-afae-afe636f95f3a), via openFDA; the full label on DailyMed

What do FAERS reports show?

765 reports list aminocaproic acid among the medicines taken, each a report of something that happened, not proof the medicine caused it; 141 are coded as a death and 288 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, 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

  • Haemorrhage129
  • Off Label Use (a use or a product term, not a reaction)64
  • Drug Ineffective (a use or a product term, not a reaction)51
  • Epistaxis49
  • Death (an outcome recorded in the report)37
  • Fall35
  • Haemarthrosis33
  • Mouth Haemorrhage31
  • Pain29
  • Hypotension (named in the label)28
  • Thrombocytopenia (a use or a product term, not a reaction)25
  • Contusion24
  • Pyrexia24
  • Anaemia20
  • Head Injury20
  • Fatigue19
  • Injury19
  • Platelet Count Decreased19
  • Renal Failure (named in the label)19
  • Anxiety18
  • Deep Vein Thrombosis18
  • Gingival Bleeding18
  • Dyspnoea (named in the label)17
  • Hypersensitivity (named in the label)17
  • Nausea (named in the label)17

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

What next?

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