PMID- 27152880 OWN - NLM STAT- MEDLINE DCOM- 20171121 LR - 20180226 IS - 2047-2927 (Electronic) IS - 2047-2919 (Linking) VI - 4 IP - 5 DP - 2016 Sep TI - Tamoxifen in men: a review of adverse events. PG - 776-88 LID - 10.1111/andr.12197 [doi] AB - Tamoxifen is an off-label option to treat men for breast cancer, infertility, and idiopathic gynecomastia. Lately, tamoxifen has been proposed as a treatment to prevent gynecomastia in prostate cancer patients receiving antiandrogen therapy. We reviewed the adverse events (AEs) reported in studies of men prescribed tamoxifen for these conditions to better understand its side-effect profile. We searched PubMed for randomized controlled trials (RCTs) that included safety data of tamoxifen treatment in men with prostate cancer, breast cancer, infertility, and idiopathic gynecomastia. Non-RCTs were also reviewed. The results demonstrate that the AE profile in tamoxifen-treated male populations varied. Excluding breast events, gastrointestinal, and cardiovascular problems were the most commonly reported AEs in prostate cancer patients, whereas more psychiatric disorders were reported in male breast cancer patients. Few AEs have been documented in men receiving tamoxifen for infertility and idiopathic gynecomastia. Less than 5% of men withdrew from tamoxifen therapy because of toxicity. This suggests that for most men, tamoxifen is well-tolerated. Of those who discontinued tamoxifen, the majority were male breast cancer patients, and cardiovascular events were the most common reason for stopping tamoxifen treatment. Unfortunately, in many cases, the reasons for withdrawing tamoxifen were unspecified. Based on the available evidence, tamoxifen's AE profile appears to vary depending upon which male population is treated. Also, the frequency at which AEs occur varies - less AEs in men with infertility and idiopathic gynecomastia compared to men with prostate cancer or breast cancer. Long-term studies that rigorously document the side-effect profile of tamoxifen in men are lacking. CI - (c) 2016 American Society of Andrology and European Academy of Andrology. FAU - Wibowo, E AU - Wibowo E AD - Vancouver Prostate Centre, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada. FAU - Pollock, P A AU - Pollock PA AD - Vancouver Prostate Centre, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada. FAU - Hollis, N AU - Hollis N AD - Solid Organ Transplant Clinic, Vancouver General Hospital, Vancouver, BC, Canada. FAU - Wassersug, R J AU - Wassersug RJ AD - Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada. LA - eng PT - Journal Article PT - Review DEP - 20160506 PL - England TA - Andrology JT - Andrology JID - 101585129 RN - 0 (Antineoplastic Agents, Hormonal) RN - 0 (Selective Estrogen Receptor Modulators) RN - 094ZI81Y45 (Tamoxifen) SB - IM MH - Antineoplastic Agents, Hormonal/*adverse effects/therapeutic use MH - Breast Neoplasms, Male/*drug therapy MH - Gynecomastia/*drug therapy MH - Humans MH - Infertility, Male/*drug therapy MH - Male MH - Off-Label Use MH - Prostatic Neoplasms/*drug therapy MH - Selective Estrogen Receptor Modulators/*adverse effects/therapeutic use MH - Tamoxifen/*adverse effects/therapeutic use OTO - NOTNLM OT - adverse events OT - antiandrogen OT - breast cancer OT - gynecomastia OT - infertility OT - males OT - prostate cancer OT - tamoxifen EDAT- 2016/05/07 06:00 MHDA- 2017/11/29 06:00 CRDT- 2016/05/07 06:00 PHST- 2015/09/18 00:00 [received] PHST- 2016/03/09 00:00 [revised] PHST- 2016/03/12 00:00 [accepted] PHST- 2016/05/07 06:00 [entrez] PHST- 2016/05/07 06:00 [pubmed] PHST- 2017/11/29 06:00 [medline] AID - 10.1111/andr.12197 [doi] PST - ppublish SO - Andrology. 2016 Sep;4(5):776-88. doi: 10.1111/andr.12197. Epub 2016 May 6.