What the label lists and what reports show
Goserelin side effects
Goserelin's FDA label: “The most common, clinically significant adverse reactions occurring in >10% of men: hot flashes, sexual dysfunction, decreased erections and lower urinary tract symptoms ( 6 ) The adverse event profile was similar for women treated for breast cancer …” FAERS holds 13,348 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is malignant neoplasm progression (1,340 reports).
- No generic listed
Check it at the source: the goserelin FDA label on DailyMed (effective March 24, 2026, TerSera Therapeutics LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common, clinically significant adverse reactions occurring in >10% of men: hot flashes, sexual dysfunction, decreased erections and lower urinary tract symptoms ( 6 ) The adverse event profile was similar for women treated for breast cancer, dysfunctional uterine bleeding or endometriosis and included (>20%): hot flushes, headache, sweating, acne, emotional lability, depression, decreased libido, vaginitis, breast atrophy, seborrhea, and peripheral edema […]
Table 4 TREATMENT RECEIVED
| ADVERSE EVENT | ZOLADEX (n=411) % | DANAZOL (n=207) % |
|---|---|---|
| Hot Flushes | 96 | 67 |
| Vaginitis | 75 | 43 |
| Headache | 75 | 63 |
| Emotional Lability | 60 | 56 |
| Libido Decreased | 61 | 44 |
| Sweating | 45 | 30 |
| Depression | 54 | 48 |
| Acne | 42 | 55 |
| Breast Atrophy | 33 | 42 |
| Seborrhea | 26 | 52 |
| Peripheral Edema | 21 | 34 |
| Breast Enlargement | 18 | 15 |
| Pelvic Symptoms | 18 | 23 |
| Pain | 17 | 16 |
| Dyspareunia | 14 | 5 |
| Libido Increased | 12 | 19 |
| Infection | 13 | 11 |
| Asthenia | 11 | 13 |
| Nausea | 8 | 14 |
| Hirsutism | 7 | 15 |
| Insomnia | 11 | 4 |
| Breast Pain | 7 | 4 |
| Abdominal Pain | 7 | 7 |
| Back Pain | 7 | 13 |
| Flu Syndrome | 5 | 5 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common, clinically significant adverse reactions occurring in >10% of men: hot flashes, sexual dysfunction, decreased erections and lower urinary tract symptoms ( 6 ) The adverse event profile was similar for women treated for breast cancer, dysfunctional uterine bleeding or endometriosis and included (>20%): hot flushes, headache, sweating, acne, emotional lability, depression, decreased libido, vaginitis, breast atrophy, seborrhea, and peripheral edema ( 6 ) Tumor flare can occur on the initiation of ZOLADEX for both men and women being treated for cancer ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact TerSera Therapeutics at 1-844-334-4035 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Stage B2-C Prostatic Carcinoma Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing ZOLADEX + flutamide + radiation versus radiation alone.
Source: FDA drug label, TerSera Therapeutics LLC, effective March 24, 2026 (SPL set 294b168b-6e5f-4db9-bf70-d599271458b3), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,348 reports list goserelin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,403 are coded as a death and 3,937 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Goserelin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions