Adverse effect · Oxytocin (intranasal)

How common is safety with Oxytocin (intranasal)?

B
Grade B — probable, not settledMultiple RCTs · effect size: small · adverse
Short answerProbable, not settled. Human data exist (Multiple RCTs) and mostly agree, showing a small effect — but too few, too small, or not yet peer-reviewed for a firm answer. Short-term intranasal use is well tolerated, with adverse events similar to placebo in the large trials. Long-term safety of daily self-dosing is not established.

What the studies show

Short-term intranasal use is well tolerated, with adverse events similar to placebo in the large trials. Long-term safety of daily self-dosing is not established.

“The incidence and severity of adverse events were similar in the two groups.”

Verbatim, from the abstractSikich L, et al. Intranasal oxytocin in children and adolescents with autism spectrum disorder (SOARS-B). N Engl J Med, 2021;385:1462–1473

Human trials exist and mostly agree, but there are too few of them, they are too small, or one big one is still reading out. Expect the grade to move.

  1. 1
    Sikich L, et al. Intranasal oxytocin in children and adolescents with autism spectrum disorder (SOARS-B).N Engl J Med, 2021;385:1462–1473290 participants, 24 weeks; primary and secondary outcomes null.

In context

Oxytocin is a natural nine-amino-acid hormone, licensed for decades as an injection to induce labour and control bleeding. The compound sold and discussed in the peptide world is intranasal oxytocin, promoted for bonding, appetite and social behaviour. Here the evidence is largely negative: the largest randomised trial in autism found no benefit, and a randomised obesity trial found no weight loss. It is well tolerated, but the popular claims rest on small early studies that the big trials did not confirm.

Oxytocin (intranasal) is approved (rx) as injection; intranasal use unlicensed. Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is Oxytocin (intranasal) proven to cause safety?
Not yet settled. Multiple RCTs — LYO grades it B, meaning probable but liable to change as trials read out.
What studies are behind the grade?
Short-term intranasal use is well tolerated, with adverse events similar to placebo in the large trials. Long-term safety of daily self-dosing is not established.
Is Oxytocin (intranasal) approved for this?
Oxytocin (intranasal) is an approved medicine (Approved (Rx) as injection; intranasal use unlicensed); whether this particular outcome is a licensed indication is stated on the compound page's regulation section.

Other outcomes for Oxytocin (intranasal)

Written and maintained by LYO Research — how pages are written and checked. Reviewed 3 September 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →