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What the label lists and what reports show

Cosyntropin side effects

Cosyntropin's FDA label: “Most common adverse reactions are: anaphylactic reaction, bradycardia, tachycardia, hypertension, peripheral edema, and rash To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc.” FAERS holds 217 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 foetal growth restriction (24 reports).

  • Generic listed

Check it at the source: the cosyntropin FDA label on DailyMed (effective January 30, 2025, Amphastar Pharmaceuticals, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions are: anaphylactic reaction, bradycardia, tachycardia, hypertension, peripheral edema, and rash To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc.

From the label: adverse reactions, continued

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of CORTROSYN: anaphylactic reaction bradycardia tachycardia hypertension peripheral edema rash Most common adverse reactions are: anaphylactic reaction, bradycardia, tachycardia, hypertension, peripheral edema, and rash To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: FDA drug label, Amphastar Pharmaceuticals, Inc., effective January 30, 2025 (SPL set 746856e9-3930-4f6a-b8e6-a03845d6dd0b), via openFDA; the full label on DailyMed

What do FAERS reports show?

217 reports list cosyntropin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 27 are coded as a death and 95 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, 2 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

  • Foetal Growth Restriction24
  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)23
  • Hypoglycaemia20
  • Hypotension18
  • Dyspnoea13
  • Pneumonia13
  • Nausea12
  • Hyperkalaemia11
  • Sepsis11
  • Adrenal Insufficiency10
  • Rash (named in the label)10
  • Dizziness8
  • Off Label Use (a use or a product term, not a reaction)8
  • Syncope8
  • Headache7
  • Hypertension (named in the label)7
  • Anxiety6
  • Drug Ineffective (a use or a product term, not a reaction)6
  • Fall6
  • Hypoglycaemia Neonatal6
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)6
  • Thrombocytopenia6
  • Tremor6
  • Asthenia5
  • Fatigue5

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

What next?

Cosyntropin: the full record
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Side effects hub
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