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This study aimed to investigate the frequency, clinical characteristics, and associated drugs of severe APD-associated GIH.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Severe cases of GIH reported within the multicentred observational pharmacovigilance project \u201cArzneimittelsicherheit in der Psychiatrie\u201d (AMSP) between 1993 and 2016 were retrospectively analysed. Among 495,615 psychiatric inpatients, 333,175 were treated with APDs. Severe GIH (including severe constipation, subileus and ileus) associated with APDs, were identified and analysed. Descriptive statistics and Fisher\u2019s exact tests or chi-squared tests were performed where appropriate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 41 cases of severe GIH was documented among 333,175 APD-treated patients (0.012%). Severe constipation accounted for 46.3% of all documented cases, followed by subileus (31.7%) and ileus (22.0%). Clozapine was the APD most frequently implicated among reported severe GIH cases (48.8% of all cases), followed by quetiapine (31.7%). Most cases involved a combination of imputed drugs (70.7%), frequently including drugs with strong anticholinergic properties. Particularly, concomitant treatment with pirenzepine was associated with a higher reporting frequency (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.027) of severe GIH among clozapine treated patients. Three patients (7.3% of GIH cases) died following paralytic ileus associated with clozapine treatment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Severe APD-associated GIH seems to be rare but potentially fatal, although the true incidence may be underestimated due to the focus on severe cases and pharmacovigilance-based reporting. Clozapine and concomitant anticholinergic drugs were frequently implicated in severe GIH cases and may contribute to increased vulnerability. Careful assessment, clinical monitoring, and patient education regarding early symptoms are important in prevention.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00406-026-02381-0","type":"journal-article","created":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T06:24:15Z","timestamp":1789799055000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Severe antipsychotic-associated gastrointestinal hypomotility: AMSP pharmacovigilance data from 333,175 psychiatric inpatients"],"prefix":"10.1007","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-9585-4744","authenticated-orcid":false,"given":"Lene","family":"Bleich","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5004-3824","authenticated-orcid":false,"given":"Stefan","family":"Bleich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kirsten","family":"Bleich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joris","family":"Bleich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pinar","family":"Ortak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8678-7419","authenticated-orcid":false,"given":"Johanna","family":"Seifert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renate","family":"Grohmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominik","family":"Dabbert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4734-1198","authenticated-orcid":false,"given":"Susanne","family":"St\u00fcbner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3870-3521","authenticated-orcid":false,"given":"Andreas","family":"Erfurth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Waldemar","family":"Greil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8311-0138","authenticated-orcid":false,"given":"Gregor","family":"Hasler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelius","family":"Sch\u00fcle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Detlef","family":"Degner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8859-6907","authenticated-orcid":false,"given":"Sermin","family":"Toto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,9,19]]},"reference":[{"key":"2381_CR1","doi-asserted-by":"publisher","first-page":"865","DOI":"10.1176\/appi.ajp.20240738","volume":"181","author":"S Leucht","year":"2024","unstructured":"Leucht S, Priller J, Davis JM (2024) Antipsychotic drugs: a concise review of history, classification, indications, mechanism, efficacy, side effects, dosing, and clinical application. 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All other authors declare that they have no conflict of interest.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The AMSP project and the evaluation of the collected data were authorized by AMSP representatives from Germany, Austria, and Switzerland and the ethics committees of the Ludwig-Maximilians-University of Munich and Hannover Medical School (Nr. 8100_BO_S_2018). This study adheres to the Declaration of Helsinki and its later adaptations. The AMSP program in no way interferes with the treatment of hospitalized patients due to its nature of being an observational post-marketing drug surveillance program. Moreover, data used in this study were obtained from the anonymized data bank of the AMSP program and therefore, individual patients cannot be retraced.","order":2,"name":"Ethics","label":"Ethical approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}