Goserelin (Zoladex)
Goserelin acetate ([D-Ser(But)6, Azgly10]-LHRH)
Approved status applies to specific products, routes, and indications, not every use context discussed online.
An FDA-approved slow-release implant (Zoladex) placed under the skin once monthly or every three months to suppress sex hormone production. It is used for prostate cancer, breast cancer, endometriosis, and uterine fibroids.
Safety Summary
The adverse effect profile is primarily driven by the expected consequences of gonadal steroid deprivation. In men with prostate cancer, hot flashes (62%), sexual dysfunction (21%), and decreased erections (18%) are most common (FDA label, n=242). In women treated for breast cancer, hot flashes occurred in 70-76% and decreased libido in 47.7% (FDA label). For endometriosis, hot flushes (96%), vaginitis (75%), headache (75%), emotional lability (60%), and depression (54%) were reported (FDA label, n=411). Bone mineral density decreases by approximately 4.3% at the vertebral spine after 6 months of treatment in women, with partial recovery (to 2.4-2.5% loss vs baseline) 6-12 months post-treatment (FDA label). HRT add-back can mitigate bone loss without compromising efficacy (FDA label). Injection site vascular injury has been reported, including hemorrhagic shock requiring transfusion (FDA label). The 16-gauge needle of the standard implant causes more discomfort than typical injections; a reformulated microsphere version (LY01005) using a 21-gauge needle showed 0% injection-site reactions vs 1.4% for the standard implant (PMID 37010251, PMID 36895949). Cardiovascular safety data from the ISACS registry showed no significant left ventricular dysfunction after one year of goserelin plus tamoxifen (PMID 39860490). Long-term use in men is associated with increased risks of diabetes and cardiovascular disease including MI, sudden cardiac death, and stroke (FDA label).
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Sources: [1-15]