The DOI matches its Crossref record; 68 of the 73 references it cites were found in a registry or an index.
A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research
Abstract
Background Human research investigating the impact of intranasal oxytocin on psychological processes has accelerated over the last two decades. No review of side effects, subjective reactions and safety is available. Method A systematic review of 38 randomised controlled trials conducted between 1990 and 2010 that investigated the central effects of intranasal oxytocin was undertaken. A systematic search for reports of adverse reactions involving intranasal oxytocin was also completed. Results Since 1990, research trials have reported on N=1529 (79% male) of which 8% were participants with developmental or mental health difficulties. Dosages ranged from 18 to 40 IU, mainly in single doses but ranged up to 182 administrations. Diverse methods have been used to screen and exclude participants, monitor side effects and subject reactions. Side effects are not different between oxytocin and placebo and participants are unable to accurately report on whether they have received oxytocin and placebo. Three case reports of adverse reactions due to misuse and longer-term use of intranasal oxytocin were reported. Conclusions The evidence shows that intranasal oxytocin: (1) produces no detectable subjective changes in recipients, (2) produces no reliable side-effects, and (3) is not associated with adverse outcomes when delivered in doses of 18-40 IU for short term use in controlled research settings. Future research directions should include a focus on the dosage and duration of use, and application with younger age groups, vulnerable populations, and with females.
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In the citing paper
“This timing and dosage are by far the most commonly used in oxytocin administration studies to date.25”
From Intranasal oxytocin enhances intrinsic corticostriatal functional connectivity in women (2017) · cites this paper as [25]
In the citing paper
“These authors reported that intranasal OT produces no detectable subjective changes in recipients and no reliable side effects, and that it is not associated with adverse outcomes when delivered in doses of 18–40 IU for short-term use in controlled research settings.”
From Oxytocin under opioid antagonism leads to supralinear enhancement of social attention (2017) · cites this paper as [68]
In the citing paper
“Acute OT administration reveals few safety concerns (17).”
From Chronic intranasal oxytocin causes long-term impairments in partner preference formation in male prairie voles (2013) · cites this paper as [17]
In the citing paper
“Acute intranasal OXT seems to produce no negative side effects in both healthy volunteers and subjects with developmental or mental health difficulties when delivered in doses of 18-40 IU (MacDonald et al, 2011).”
From Chronic and acute intranasal oxytocin produce divergent social effects in mice (2014) · cites this paper as MacDonald et al, 2011
In the citing paper
“While the overall safety of single doses of intranasal oxytocin are well established (MacDonald et al., 2011)”
From Augmenting Prolonged Exposure therapy for PTSD with intranasal oxytocin: a randomized, placebo-controlled pilot trial (2018) · cites this paper as MacDonald et al., 2011
In the citing paper
“The dose and timing of medication administration is based on past research in our group and others (Cardoso et al., 2013; Flanagan et al., 2015; MacDonald et al., 2011).”
From Augmenting Prolonged Exposure therapy for PTSD with intranasal oxytocin: a randomized, placebo-controlled pilot trial (2018) · cites this paper as MacDonald et al., 2011
In the citing paper
“could enter the central nervous system through intracellular junctions of the olfactory epithelia 76 to mimic endogenous oxytocin release 77”
From Beyond the hype and hope: critical considerations for intranasal oxytocin research in autism spectrum disorder (2017) · cites this paper as [76]
In the citing paper
“it has been proposed that the efficacy of oxytocin administration depends on dosage.10, 12, 13”
From Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial (2016) · cites this paper as [13]
In the citing paper
“A dose of 40 IU twice a day is comparable to the doses previously used in human studies investigating effects of multiple treatments of oxytocin [61,62] and does not produce significant side effects or adverse outcomes [63].”
From Efficacy of oxytocin administration early after psychotrauma in preventing the development of PTSD: study protocol of a randomized controlled trial (2014) · cites this paper as [63]
In the citing paper
“intranasal oxytocin administration has been shown to reliably modulate neuropsychological functions in a series of studies (2–5) in the absence of relevant side effects (16).”
From Oxytocin Reduces Reward-Driven Food Intake in Humans (2013) · cites this paper as [16]
In the citing paper
“Oxytocin administered intranasally has central actions with minimal side effects, and is appealing as a potential targeted therapy for obesity(15).”
From Oxytocin reduces caloric intake in men (2015) · cites this paper as [15]
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Background
Metadata
- Authors
- MacDonald, E., Dadds, M. R., Brennan, J. L., Williams, K., Levy, F., & Cauchi, A. J.
- Affiliations
- UNSW Sydney (AU)
- Royal Children's Hospital (AU)
- Corresponding author
- Dadds, Mark R.
- Venue
- Psychoneuroendocrinology
- Publisher
- Elsevier BV
- Published
- 2011-09
- Volume
- 36
- Issue
- 8
- Pages
- 1114-1126
- ISSN
- 0306-4530 (ISSN-L)
- OpenAlex
- W2057967199
- Semantic Scholar
- 84a4c13a42b3dc1fbf0ab5392e09a084183e8ad6
- Cited by
- 359
- References
- 73
- Citations by year
- 2026: 12 · 2025: 13 · 2024: 15 · 2023: 19 · 2022: 23 · 2021: 22 · 2020: 33 · 2019: 28 · 2018: 24 · 2017: 32 · 2016: 28 · 2015: 22 · 2014: 34 · 2013: 33 · 2012: 14
- FWCI
- 11.19
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Psychoneuroendocrinology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Neuroendocrine regulation and behavior
- Life Sciences › Neuroscience › Sensory Systems › Olfactory and Sensory Function Studies
- Life Sciences › Neuroscience › Behavioral Neuroscience › Stress Responses and Cortisol
- Keywords
- intranasal oxytocin, drug safety, adverse effects, subjective reactions, placebo effect, vulnerable populations, research ethics
- MeSH terms
- Administration, Intranasal, Female, Humans, Human Experimentation, Male, Mental Processes, Oxytocin, Research, Randomized Controlled Trials as Topic, Drug-Related Side Effects and Adverse Reactions
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