Is vasopressin FDA-approved, and what does the research show?

What is vasopressin?

Vasopressin is a hormone the body makes, also called antidiuretic hormone because at low levels it tells the kidneys to hold on to water ¹. The label calls it a polypeptide hormone, a short chain of nine amino acids ¹. The medicine is synthetic arginine vasopressin in sterile water or dextrose, for infusion into a vein ². At the higher doses used as a medicine it narrows blood vessels, which is why it is given in shock ².

Desmopressin is a different molecule with its own page. The vasopressin label names it only as one way to correct the water loss that can follow stopping vasopressin ².

Is vasopressin FDA-approved?

Yes. Vasopressin is approved by FDA as the prescription medicine Vasostrict, with initial U.S. approval in 2014 ². FDA's Drugs@FDA record shows the new drug application, NDA 204485, approved April 17, 2014, with marketing status "Prescription" on its marketed strengths ³. The label approves it "to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines" ².

Vasodilatory shock is a collapse of blood pressure because the blood vessels have opened too wide. The 2014 approval letter's examples are septic shock, shock from severe infection, and post-cardiotomy shock, shock after heart surgery ⁸.

"Hypotensive" means the blood pressure is too low ². Catecholamines are the first-line pressor drugs, norepinephrine among them, that raise blood pressure in shock ⁵. So the label's patient is already on intravenous fluids and a first-line pressor drug and still too low ². That is the whole approved use ².

The approval came late for an old drug. FDA's review of the application records that "Vasopressin has been marketed as a therapeutic agent for nearly a century," and that before 2014 "intravenous vasopressin has been marketed but unapproved" ⁷. The applicant, Par Sterile Products, filed under section 505(b)(2) of the drug law, a route that let it rely on published studies rather than new trials of its own ⁸, ⁷. An older vasopressin product, Pitressin Tannate in Oil (vasopressin tannate injection), had held an FDA approval under NDA 03-402 ⁹. FDA withdrew that approval effective September 25, 1998, and in 2012 determined the product "was not withdrawn from sale for reasons of safety or effectiveness" ⁹.

Drugs@FDA classes the application as a "Drug Already Marketed without Approved NDA" ³. FDA has since approved vasopressin injections from other makers, the latest in May 2026 ⁴.

It is prescription-only ³. The label's use is in an adult already in shock on fluids and pressor drugs, by intravenous infusion ². The label on Drugs@FDA is dated April 2023 ².

See the FDA status of every peptide, updated weekly.

How does vasopressin work?

Vasopressin binds to V1 receptors on the muscle in blood vessel walls, which releases calcium inside those cells and makes the vessels narrow ². Narrower vessels raise the resistance the heart pumps against, and with it the mean arterial pressure, the average pressure in the arteries ². In patients with vasodilatory shock, the label says, it raises that pressure and lowers the amount of norepinephrine needed ². Through a second receptor, V2, it also acts on the kidney to reduce urine output, its hormone role ².

The pressor effect peaks within 15 minutes and fades within 20 minutes after the infusion stops ². Vasopressin also tends to slow the heart and reduce the heart's output ². That is the label's account of an approved drug's mechanism ². Angiotensin II, another FDA-approved vasopressor for shock, is a different molecule with its own page.

What does the research show?

The evidence for vasopressin is at the top tier, FDA approval, but the approval rests on published studies rather than trials run for it ⁷. FDA's statistical reviewer found that the published studies did not meet the standard of an "adequate and well controlled study," with no predefined primary endpoint and selective reporting ⁷. The review team leader concluded that "the totality of the evidence," consistent across studies by different investigators, was adequate to show that vasopressin raised arterial blood pressure ⁷. The label's clinical studies section says the same in one sentence: increases in blood pressure were observed in 7 studies in septic shock and 8 in post-cardiotomy shock ².

Studied in people against norepinephrine: VASST, published February 28, 2008, was a multicenter, randomized, double-blind trial, so neither patients nor clinicians knew which drug was given ⁵. It assigned 778 patients with septic shock who were already on norepinephrine to low-dose vasopressin, 396 patients, or more norepinephrine, 382, on top of open-label pressor drugs ⁵. The primary end point was death within 28 days of the start of the infusion ⁵.

Deaths at 28 days were 35.4 percent on vasopressin and 39.3 percent on norepinephrine, a difference that was not statistically significant ⁵. At 90 days they were 43.9 against 49.6 percent, again not significant ⁵. Serious adverse events were 10.3 and 10.5 percent ⁵.

In the predefined group with less severe shock, 28-day deaths were 26.5 against 35.7 percent ⁵. In more severe shock they were 44.0 against 42.5 percent, and a test of whether the drug's effect differed between the less and more severe groups was not significant ⁵. The authors concluded that low-dose vasopressin did not reduce deaths compared with norepinephrine ⁵. FDA's reviewer wrote in 2014 that the less-severe-shock finding "has not been further studied in a prospective randomized, controlled trial" to the reviewer's knowledge ⁷.

Studied in people for kidney outcomes: VANISH, published August 2, 2016, was a double-blind, randomized trial in 18 adult intensive care units in the United Kingdom ⁶. It enrolled 409 adults with septic shock who needed pressor drugs despite fluids, within six hours of the shock starting ⁶. Four arms of 101 to 104 patients received vasopressin or norepinephrine, each with hydrocortisone or placebo ⁶. The primary outcome was days alive and free of kidney failure over 28 days ⁶.

Among survivors, 94 of 165 on vasopressin, 57.0 percent, never developed kidney failure, against 93 of 157 on norepinephrine, 59.2 percent ⁶. That is a difference of minus 2.3 points, with a 95 percent confidence interval of minus 13.0 to 8.5 ⁶. Fewer patients on vasopressin needed renal replacement therapy, kidney support such as dialysis: 25.4 against 35.3 percent ⁶. That difference, minus 9.9 points, had a confidence interval of minus 19.3 to minus 0.6 ⁶.

Deaths did not differ significantly ⁶. Serious adverse events occurred in 22 of 205 on vasopressin, 10.7 percent, and 17 of 204 on norepinephrine, 8.3 percent ⁶. The authors wrote that early vasopressin did not improve kidney-failure-free days, and that the findings do not support replacing norepinephrine as the first treatment ⁶. They added that the confidence interval left room for a clinically important benefit, and that larger trials may be warranted ⁶.

No trial of vasopressin outside shock, in healthy people, or for weight, performance or wellness was found among this page's sources as of November 10, 2026 ⁵, ¹, ², ⁷, ⁶. Every trial above enrolled patients in septic shock who already needed pressor drugs ⁵, ⁶.

What are the side effects?

The label's adverse reactions come from the published literature, reported, it says, "from a population of uncertain size," so their frequency cannot be estimated reliably ². The most common are decreased cardiac output, slow heart rate, fast abnormal rhythms, low blood sodium, and ischemia ². Ischemia is a loss of blood supply, here in the heart, the gut, the skin and the fingers and toes ².

The label also lists hemorrhagic shock, low platelets and intractable bleeding, and right heart failure, atrial fibrillation and myocardial ischemia ². It lists mesenteric ischemia, which is loss of blood supply to the bowel, raised bilirubin, acute kidney insufficiency, distal limb ischemia and ischemic skin lesions ². From post-marketing reports it adds reversible diabetes insipidus, a condition of water loss through the urine ².

FDA's reviewer wrote that "High doses of vasopressin have been associated with cardiac, digital and splanchnic ischemia" ⁷. Splanchnic means the gut's blood supply, and digital means the fingers and toes.

The label carries two warnings. First, "A decrease in cardiac index may be observed with the use of vasopressin," a fall in how much blood the heart pumps for the body's size ². Second, patients "may experience reversible diabetes insipidus," with large volumes of dilute urine and high blood sodium, after the treatment stops ². The label calls for monitoring of electrolytes, fluids and urine output afterward ².

The multiple-dose vial "is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol," a preservative ². The single-dose and premixed vials contain no chlorobutanol and are contraindicated only in allergy to vasopressin itself ².

The label has no data on use in pregnancy and warns it "may produce tonic uterine contractions that could threaten the continuation of pregnancy" ². Safety and effectiveness in children with vasodilatory shock "have not been established," and the studies did not include enough people aged 65 and over to tell whether they respond differently ². An overdose shows as narrowing of blood vessels in the limbs, gut and heart and as low sodium, and less commonly as dangerous heart rhythms, muscle breakdown and gut symptoms ². Pressor effects of catecholamines and vasopressin are expected to add together, and the label names drugs that may lengthen, increase or lessen its effect ².

In sport

Vasopressin is not named on WADA's 2026 Prohibited List ¹⁰. WADA, the World Anti-Doping Agency, does name desmopressin, the different molecule above, in section S5 among diuretics and masking agents, prohibited at all times ¹⁰. WADA also lists a method that concerns infusions ¹⁰. M2.2 prohibits "Intravenous infusions and/or injections of more than a total of 100 mL per 12-hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations" ¹⁰.

What JumpstartMD offers

JumpstartMD does not prescribe vasopressin. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.