Cosyntropin

Mechanism-of-action class: Pituitary Hormone Receptor Agonists.

• Cosyntropin for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. Because of its rapid effect on the adrenal cortex it may be utilized to perform a 30-minute test of adrenal function (plasma cortisol response) as an office or outpatient procedure, using only 2 venipunctures (see DOSAGE AND ADMINISTRATION section).

• The only contraindication to Cosyntropin for Injection is a history of a previous adverse reaction to it.contraindicated

Cosyntropin for Injection may be administered intramuscularly or as a direct intravenous injection when used as a rapid screening test of adrenal function. It may also be given as an intravenous infusion over a 4 to 8 hour period to provide a greater stimulus to the adrenal glands. Doses of Cosyntropin for Injection 0.25 to 0.75 mg have been used in clinical studies and a maximal response noted with the smallest dose. A suggested method for a rapid screening test of adrenal function has been described by Wood and Associates (1). A control blood sample of 6 to 7 mL is collected in a heparinized tube. Reconstitute 0.25 mg of Cosyntropin for Injection with 1mL of 0.9% Sodium Chloride Injection, USP and inject intramuscularly. The reconstituted drug product should be inspected visually for particulate matter and discoloration prior to injection. Reconstituted Cosyntropin for Injection should not be retained. In the pediatric population, aged 2 years or less, a dose of 0.125 mg will often suffice. A second blood sample is collected exactly 30 minutes later. Both blood samples should be refrigerated until sent to the laboratory for determination of the plasma cortisol response by some appropriate method. If it is not possible to send them to the laboratory or perform the fluorimetric procedure within 12 hours, then the plasma should be separated and refrigerated or frozen according to need. Two alternative methods of administration are intravenous injection and infusion. Cosyntropin for Injection can be injected intravenously in 2 to 5 mL of saline over a 2-minute period.

Since Cosyntropin for Injection is intended for diagnostic and not therapeutic use, adverse reactions other than a rare hypersensitivity reaction are not anticipated. A rare hypersensitivity reaction usually associated with a pre-existing allergic disease and/or a previous reaction to natural ACTH is possible. Symptoms may include slight whealing with splotchy erythema at the injection site. There have been rare reports of anaphylactic reaction. The following adverse reactions have been reported in patients after the administration of Cosyntropin for Injection and the association has been neither confirmed nor refuted: • bradycardia • tachycardia • hypertension • peripheral edema • rash

Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Cosyntropin for Injection. It is also not known whether Cosyntropin for Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cosyntropin for Injection should be given to a pregnant woman only if clearly needed.

• Apr 22, 1970NDANDA016750Amphastar Pharms Inc
• Jun 29, 2012ANDAANDA202147Sandoz

1. 1Foetal Growth Restriction2411%
2. 2Foetal Exposure During Pregnancy2311%
3. 3Hypoglycaemia209.5%
4. 4Hypotension178.1%
5. 5Dyspnoea136.2%
6. 6Nausea125.7%
7. 7Pneumonia125.7%
8. 8Sepsis115.2%
9. 9Adrenal Insufficiency104.7%
10. 10Hyperkalaemia104.7%
11. 11Rash104.7%
12. 12Dizziness83.8%
13. 13Off Label Use83.8%
14. 14Syncope83.8%
15. 15Headache73.3%

Recent PubMed references pinned to Cosyntropin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Utility of the post-cosyntropin urinary metabolomic profile for the subtype diagnosis of primary aldosteronism.
  Journal of hypertension · 2026 · Araujo-Castro M, Hanzu FA, Goi J, et al.
  PMID 42160134DOI 10.1097/HJH.0000000000004329
• Determining the comparative pharmacodynamic equivalence of a non-invasive diagnostic test for patients with adrenal insufficiency using a randomised 2-way crossover trial: the STARLIT-3 study protocol.
  BMJ open · 2026 · Date K, Baster K, Caunt S, et al.
  PMID 41644156DOI 10.1136/bmjopen-2025-112708
• Adrenal vein sampling with continuous infusion of cosyntropin for identifying surgically curable cases of primary aldosteronism.
  Clinical imaging · 2026 · Liu L, Trivedi P, Marchak K, et al.
  PMID 41202648DOI 10.1016/j.clinimag.2025.110664
• Morning serum cortisol as a predictor of synacthen stimulation test outcomes during corticosteroid withdrawal: a comparative analysis of high-dose and low-dose protocols.
  Frontiers in endocrinology · 2025 · Saiegh L, Dakwar B, Jovanovic K, et al.
  PMID 41122714DOI 10.3389/fendo.2025.1655146
• Predicting the outcome of short Synacthen test based on baseline cortisol levels: A single-centered retrospective cohort study at a tertiary care hospital in Sri Lanka.
  Annals of clinical biochemistry · 2026 · Premadasa T, Samarathunga E, Sujith EM, et al.
  PMID 40954102DOI 10.1177/00045632251383417
• Adrenocorticotropic hormone combined with vigabatrin as a second-line therapy for West syndrome.
  Arquivos de neuro-psiquiatria · 2025 · Souza LP, Bufara DC, Tensini TS, et al.
  PMID 40835197DOI 10.1055/s-0045-1811172
• Cosyntropin-Stimulated Aldosterone Reserve of the Nondominant Adrenal Predicts Surgical Outcomes in Primary Aldosteronism.
  Hypertension (Dallas, Tex. : 1979) · 2025 · Vibhatavata P, Shields JJ, Rege J, et al.
  PMID 40755305DOI 10.1161/HYPERTENSIONAHA.125.24999
• Redefining the Diagnostic Approach to Adrenal Insufficiency: Re-Assessment of Baseline and Cortisol Increment Cut-Offs with the 1 µg Synacthen Test.
  Medicina (Kaunas, Lithuania) · 2025 · Ach T, Dhaffar R, Ammar A, et al.
  PMID 40731932DOI 10.3390/medicina61071303

The 10 most recently updated of 41 ClinicalTrials.gov registrations naming Cosyntropin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Screening and Stimulation Testing for Residual Secretion of Adrenal Steroid Hormones in Autoimmune Addison's Disease
  Active not recruiting · Interventional · 200 enrolled · University of Bergen
  NCT03793114updated 2026-05-08
• Updated Diagnostic Cortisol Values for Adrenal Insufficiency
  Recruiting · Interventional · 90 enrolled · Montefiore Medical Center
  NCT05149638updated 2026-02-19
• Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
  Recruiting · Early phase 1 · Interventional · 24 enrolled · Benjamin Viglianti
  NCT04546126updated 2025-12-05
• Stress and the Nervous System
  Completed · Interventional · 23 enrolled · Brigham and Women's Hospital
  NCT02339506updated 2025-12-03
• Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women
  Active not recruiting · Early phase 1 · Interventional · 5 enrolled · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  NCT04037605updated 2025-09-11
• Hormonal Mechanisms of Sleep Restriction - Axis Study
  Active not recruiting · Phase 1 · Interventional · 80 enrolled · Peter y. Liu
  NCT03142893updated 2025-09-11
• Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
  Terminated · Phase 2 · Interventional · 46 enrolled · Hospices Civils de Lyon
  NCT02813655updated 2025-08-08
• Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease
  Recruiting · Early phase 1 · Interventional · 125 enrolled · Brigham and Women's Hospital
  NCT06190158updated 2025-04-09
• Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis
  Completed · Observational · 76 enrolled · University of Virginia
  NCT04642391updated 2024-12-10
• NeSST2: The Development of a Noninvasive Short Synacthen Test
  Recruiting · Phase 2 · Interventional · 12 enrolled · Sheffield Children's NHS Foundation Trust
  NCT03514589updated 2024-12-03

Frequently asked questions

How does Cosyntropin work?

Mechanism-of-action class: Pituitary Hormone Receptor Agonists.

What is Cosyntropin used for?

According to FDA labeling, Cosyntropin carries indications including: Cosyntropin for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. Because of its rapid effect on the adrenal cortex it may be utilized to perform a 30-minute test of adrenal function (plasma cortisol response) as an office or outpatient procedure, using only 2 venipunctures (see DOSAGE AND ADMINISTRATION section).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cosyntropin?

Cosyntropin is classified as ACTH, Adrenocorticotropic Hormone, Pituitary Hormone Receptor Agonists, Increased Glucocorticoid Secretion, Increased Mineralocorticoid Secretion.

What are the contraindications for Cosyntropin?

Cosyntropin labeling lists contraindications including: The only contraindication to Cosyntropin for Injection is a history of a previous adverse reaction to it.. Always consult the full prescribing information and a clinician.