Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin
Healy, David; Bahrick, Audrey; Bak, Maarten; Barbato, Angelo; Calabrò, Rocco Salvatore; Chubak, Barbara M.; Cosci, Fiammetta; Csoka, Antonei B.; D'Avanzo, Barbara; Diviccaro, Silvia; Giatti, Silvia; Goldstein, Irwin; Graf, Heiko; Hellstrom, Wayne J.G.; Irwig, Michael S.; Jannini, Emmanuele A.; Janssen, Paddy K.C.; Khera, Mohit; Kumar, Manoj Therayil; Le Noury, Joanna; Lew-Starowicz, Michał; Linden, David E.J.; Lüning, Celine; Mangin, Dee; Melcangi, Roberto Cosimo; Muquebil Ali Al Shaban Rodríguez, Omar Walid; Panicker, Jalesh N.; Patacchini, Arianna; Pearlman, Amy M.; Pukall, Caroline F.; Raj, Sanjana; Reisman, Yacov; Rubin, Rachel S.; Schreiber, Rudy; Shipko, Stuart; Vašečková, Barbora; Waraich, Ahad
International Journal of Risk & Safety in Medicine · 33(1):65-762022
In plain terms
A group of 37 doctors and researchers agreed on a set of rules (diagnostic criteria) for recognising lasting sexual problems after stopping certain antidepressants, finasteride-type drugs or the acne drug isotretinoin, and for unwanted, uncomfortable genital arousal that can start when antidepressants are stopped. The shared features they describe are reduced genital and orgasm feeling, low sex drive and erection problems that continue after stopping; problems lasting three months or more are treated as more likely to be one of these conditions. They also suggested a new term for a lifelong lack of sexual interest and pleasure in people exposed to these antidepressants before birth or as children.
What it doesn’t show: It can't show how common these conditions are or prove that the drugs cause them: the rules come from experts' agreement and two collections of patient reports, and they have not yet been tested on patients.
Summary (paraphrased)
A multidisciplinary expert panel drafted formal diagnostic criteria for four enduring post-drug conditions: PSSD, persistent genital arousal disorder after serotonin reuptake inhibitors, post-finasteride syndrome, and post-retinoid sexual dysfunction. The drafts were built from the two largest published case collections (Hogan et al. 2014; Healy et al. 2018). Core shared features across PSSD, PFS, and post-retinoid dysfunction included reduced genital and orgasmic sensation, reduced desire, and erectile dysfunction, with variable non-sexual symptoms such as emotional blunting and cognitive impairment. The panel also proposed a fifth category with its own criteria, post-SSRI asexuality, a new term for dampened sexual interest and pleasure after exposure to a serotonin reuptake inhibitor before birth or before the teens. The criteria were intended to give clinicians and researchers a common case definition for a field that had lacked one.
Evidence
Extracted from the full text; page numbers refer to the paper. The library’s own notes are labelled as such.
- Design
- Expert consensusExpert consensus on diagnostic criteria; a draft built from two published case series was circulated to a multidisciplinary panel and revised until agreement
- Setting
- International panel; 37 authors from 10 countries (Canada, USA, UK, Italy, the Netherlands, Germany, Poland, Spain, Slovakia, India)
- Population
- Not applicable (criteria paper). The criteria cover people with enduring sexual dysfunction after serotonin reuptake inhibitors (SRIs), 5α-reductase inhibitors or isotretinoin, and people exposed to SRIs before birth or before their teens.
- Size
- Not applicable. 37 listed authors. Starting data were two RxISK.org case series by three of the authors, of 120 (2014) and 300 (2018) cases; whether they overlap is not stated. RxISK holds about 1,000 reports of these conditions.
- Exposure
- SRIs, defined broadly (SSRIs, SNRIs, SRI tricyclics, SRI antihistamines, tetracycline antibiotics such as doxycycline, tramadol); 5α-reductase inhibitors (finasteride, dutasteride, saw palmetto); isotretinoin
- Compared with
- None
- Outcome
- Diagnostic criteria for PSSD, post-SRI persistent genital arousal disorder (PGAD), PFS, post-retinoid sexual dysfunction (PRSD) and post-SSRI asexuality
- Follow-up
- Not applicable
Key results
- PSSD. Necessary: prior SRI treatment, and an enduring change in tactile or sexual genital sensation after stopping. Additional: reduced or lost desire; erectile dysfunction (males); inability to orgasm or less pleasure in orgasm; present 3 months or more after stopping. Exclusions: matching pre-drug dysfunction, or a current medical condition, medication or substance misuse that could explain it. The genital sensory change is what distinguishes PSSD from other enduring sexual dysfunction · pp. 68–69
- PGAD after SRIs. Necessary: persistent unwelcome genital arousal or irritability that is painful or altered rather than pleasurable, gets little or no relief from sexual activity, and can be triggered by non-sexual stimuli. Additional criteria include spontaneous unwanted orgasms, marked distress, a continuous course, onset on stopping (if linked to an SRI), and presence 3 months or more after stopping · pp. 70–71
- PFS. Necessary: prior 5α-reductase inhibitor treatment, and enduring sexual dysfunction after stopping. Additional: reduced desire, erectile dysfunction, reduced genital and orgasmic sensation, present 3 months or more after stopping. No prior isotretinoin or SRI use; dysfunction that clears after stopping is not PFS. Cognitive impairment, depression and suicidality may accompany it but are not diagnostic · pp. 71–72
- PRSD. Necessary: prior isotretinoin treatment, and enduring sexual dysfunction after stopping. Additional: reduced desire, erectile dysfunction (males) or loss of vaginal lubrication (females), reduced genital and orgasmic sensation, present 3 months or more after stopping. No prior finasteride or SRI use · p. 72
- Post-SSRI asexuality (new term). Maternal SRI use in pregnancy or extended pre-teen SRI use; no sexual interest in either sex; never any pleasure from masturbation or sexual activity; identification as asexual · p. 73
- Diagnostic interviewing. No upper time limit, as PSSD and PRSD have been reported to persist for over two decades; challenge-dechallenge-rechallenge is unsuitable; a current mental health diagnosis does not rule these conditions out; testosterone treatment has not been reported to help reliably and PDE5 inhibitors appear less effective; penile quantitative sensory testing may help assess tactile sensation · p. 74
Limitations the authors note
- As with all criteria, they will likely need modification as evidence develops; the authors hope diagnostic markers will eventually replace them
- The incidence of these conditions is unknown, and full recovery after stopping has never been properly studied
- There is no biomarker; sexual (erogenous) sensation is poorly understood and there are no tests for it
- Data on the delay between the last dose and onset are limited, so no cut-off for onset can be set
- It is unclear whether penile, neurosteroid, methylation and gut microbiota findings in PFS were present before treatment, or whether erectile tissue changes are part of PSSD
- It is not clear whether men are affected by post-SRI PGAD, or whether persistent dysfunction after other drugs (mirtazapine, aripiprazole, NOACs) forms a related syndrome
Also worth weighing (library’s note)
- The draft was built from two case series drawn from RxISK.org, a site three of the authors are linked to, and both series are by those authors
- The consensus process is described only briefly; no formal method (such as Delphi), number of rounds, voting rule or dissent is reported
- Panel members include authors of earlier work on these conditions and several who petitioned regulators for label warnings
- The criteria do not say how many Additional criteria are needed, and the 3-month duration is listed as Additional, not Necessary, for PSSD, PFS and PRSD
- No testing of the criteria's reliability or validity in patients is reported
- Post-SSRI asexuality rests on animal studies and one human study cited by the authors
Funding: None to report. Acknowledgements list individual support: Jannini, Italian Ministry of University and Research grant PRIN #2017S9KTNE_002; Mangin, David Braley Chair in Family Medicine, McMaster University; Panicker, UK Department of Health NIHR Biomedical Research Centres. Interests: David Healy, Joanna Le Noury and Dee Mangin are linked to RxISK.org, which records patient-reported adverse events and has featured information on enduring sexual dysfunction; no other interests declared.
What it can support (library’s note): A proposed, consensus-based case definition for PSSD, PFS, PRSD and post-SRI PGAD, for consistent diagnosis and research. It does not show how common these conditions are, establish causation, or validate the criteria.
Why it’s in the corpus
The first proposed diagnostic criteria for PSSD and its sibling syndromes. Directly usable as the corpus's case-definition reference.
Some fields on this page come from the release’s Markdown edition, which carries text the JSON edition omits.
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