Zoladex: adverse event reports filed with FDA

7,058

reports as suspect product

0% of all reports · about 314 a year

396

reports, 12 months to June 2026

374 in the 12 months before

88.5%

marked serious by the reporter

50.5% across the class

26.2%

record death among outcomes, as reported

1,849 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Zoladex reports recording the termmedian drug in gonadotropin releasing hormone receptor agonist

1. Deaththe patient died; cause not stated by this term21.2%1,498
2. Malignant neoplasm progression10.9%768
3. Hot flusha hot flush4.8%341
4. Metastases to bone3.9%273
5. Fatiguetiredness3.8%268
6. Off label useused for a purpose or in a way not on the label2.9%203
7. Arthralgiajoint pain2.8%197
8. Astheniaweakness or lack of energy2.7%188
9. Neutropenialow neutrophils, a type of white blood cell2.4%168
10. Metastases to liver2.3%162
11. Headachehead pain2.2%154
12. Nauseafeeling sick2.2%154
13. Painpain, site not specified2.1%151
14. Dyspnoeashortness of breath2.1%149
15. Dizzinesslight-headedness or unsteadiness1.9%137
16. Drug ineffectivethe medicine did not work as expected1.9%137
17. Falla fall1.8%128
18. Interstitial lung diseasescarring or inflammation of lung tissue1.7%118
19. Disease progressionthe disease advanced1.6%116
20. Malaisegeneral feeling of being unwell1.6%112
21. Breast cancerbreast cancer1.5%105
22. Myelosuppression1.4%100
23. Prostatic specific antigen increased1.4%98
24. Vomitingbeing sick1.4%98
25. Weight increasedweight gain1.3%94
26. Back painback pain1.3%92
27. Diarrhoealoose or frequent stools1.3%92
28. Weight decreasedweight loss1.3%91
29. Depressionlow mood1.3%89
30. Hypertensionhigh blood pressure1.2%88

Top 30 of 903 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the gonadotropin releasing hormone receptor agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 61,409 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 16.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 7,058 reports.

Drugs most often listed in the same reports

Other products listed in reports where Zoladex is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the gonadotropin releasing hormone receptor agonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Zoladex as a suspect or interacting product; reports listing it only as a concomitant medication (3,168) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.