{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T21:02:52Z","timestamp":1784322172977,"version":"3.55.0"},"reference-count":33,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2012,1,6]],"date-time":"2012-01-06T00:00:00Z","timestamp":1325808000000},"content-version":"vor","delay-in-days":2045,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2006,6]]},"abstract":"<jats:p><jats:bold>Study Objective<\/jats:bold>. To analyze the disproportionality of reporting of hyperprolactinemia, galactorrhea, and pituitary tumors with seven widely used antipsychotic drugs.<\/jats:p><jats:p><jats:bold>Design<\/jats:bold>. Retrospective pharmacovigilance study.<\/jats:p><jats:p><jats:bold>Data Source<\/jats:bold>. United States Food and Drug Administration's Adverse Event Reporting System (AERS) database.<\/jats:p><jats:p><jats:bold>Intervention<\/jats:bold>. We initially identified higher\u2010than\u2010expected postmarketing reports of pituitary tumors associated with risperidone, a potent dopamine D<jats:sub>2<\/jats:sub>\u2010receptor antagonist antipsychotic, by analyzing reporting patterns of these tumors in the AERS database. To further examine this association, we analyzed disproportionate reporting patterns of pituitary tumor reports for seven antipsychotics with different affinities for blocking D<jats:sub>2<\/jats:sub> receptors: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone, and haloperidol.<\/jats:p><jats:p><jats:bold>Measurements and Main Results<\/jats:bold>. To conduct both of these analyses, we used the Multi\u2010item Gamma Poisson Shrinker (MGPS) data mining algorithm applied to the AERS database. The MGPS uses a Bayesian model to calculate adjusted observed:expected ratios of drug\u2013adverse event associations (Empiric Bayes Geometric Mean [EBGM] values) in huge drug safety databases. The higher the adjusted reporting ratio, or EBGM value, the greater the strength of the association between a drug and an adverse event. Risperidone had the highest adjusted reporting ratios for hyperprolactinemia (EBGM 34.9, 90% confidence interval [CI] 32.8\u201337.1]), galactorrhea (EBGM 19.9, 90% CI 18.6\u201321.4), and pituitary tumor (EBGM 18.7, 90% CI 14.9\u201323.3) among the seven antipsychotics, and one of the highest scores for all drugs in the AERS database. Some tumors were associated with visual field defects, hemorrhage, convulsions, surgery, and severe (&gt; 10\u2010fold) prolactin elevations. The EBGM values for risperidone for these adverse events were higher in women, but high EBGM values for these events were also seen in men and children. Moreover, the rank order of the EBGM values for pituitary tumors corresponded to the affinities of these seven drugs for D<jats:sub>2<\/jats:sub> receptors.<\/jats:p><jats:p><jats:bold>Conclusion<\/jats:bold>. Treatment with potent D<jats:sub>2<\/jats:sub>\u2010receptor antagonists, such as risperidone, may be associated with pituitary tumors. These findings are consistent with animal (mice) studies and raise the need for clinical awareness and longitudinal studies.<\/jats:p>","DOI":"10.1592\/phco.26.6.748","type":"journal-article","created":{"date-parts":[[2006,5,22]],"date-time":"2006-05-22T13:14:16Z","timestamp":1148303656000},"page":"748-758","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":123,"title":["Atypical Antipsychotics and Pituitary Tumors: A Pharmacovigilance Study"],"prefix":"10.1002","volume":"26","author":[{"given":"Ana","family":"Szarfman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph M.","family":"Tonning","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan G.","family":"Levine","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P. Murali","family":"Doraiswamy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2012,1,6]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200464200-00003"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.161.8.1334"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2004.14.359"},{"key":"e_1_2_1_5_2","doi-asserted-by":"publisher","DOI":"10.1080\/10401230490487007"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2004.14.350"},{"key":"e_1_2_1_7_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v65n1207"},{"key":"e_1_2_1_8_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v65n1108"},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.162.5.947"},{"key":"e_1_2_1_10_2","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.162.5.1010"},{"key":"e_1_2_1_11_2","doi-asserted-by":"publisher","DOI":"10.1001\/archpsyc.59.12.1147"},{"key":"e_1_2_1_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0896-6273(00)80352-9"},{"key":"e_1_2_1_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0896-6273(00)80353-0"},{"key":"e_1_2_1_14_2","unstructured":"Janssen L.P..Risperdal (risperidone) home page. 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