Abiraterone: adverse event reports filed with FDA

6,436

reports as suspect product

0% of all reports · about 420 a year

615

reports, 12 months to June 2026

523 in the 12 months before

69.9%

marked serious by the reporter

68.2% across the class

14.3%

record death among outcomes, as reported

920 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 Abiraterone reports recording the termmedian drug in cytochrome p450 17a1 inhibitor

1. Deaththe patient died; cause not stated by this term10.8%696
2. Fatiguetiredness7.4%478
3. Disease progressionthe disease advanced6.1%393
4. Hot flusha hot flush4.4%281
5. Prostatic specific antigen increased4.4%281
6. Drug ineffectivethe medicine did not work as expected4.3%278
7. Therapy interrupted3.9%248
8. Falla fall3.4%221
9. Astheniaweakness or lack of energy3.4%216
10. Drug interactionan interaction between medicines3.2%209
11. Malignant neoplasm progression2.9%187
12. Acute kidney injurysudden loss of kidney function2.7%176
13. Rhabdomyolysismuscle breakdown2.5%160
14. Urinary tract infectionbladder or urinary infection2.5%160
15. Dizzinesslight-headedness or unsteadiness2.2%140
16. Hospitalisationadmission to hospital2.2%139
17. Diarrhoealoose or frequent stools2.1%136
18. Nauseafeeling sick2%130
19. Prostate cancer2%130
20. Hypertensionhigh blood pressure2%127
21. Dyspnoeashortness of breath1.9%125
22. Off label useused for a purpose or in a way not on the label1.9%121
23. Hypokalaemialow blood potassium1.8%114
24. Anaemialow red blood cells1.6%104
25. Painpain, site not specified1.6%104
26. Pneumonialung infection1.6%102
27. Prostate cancer metastatic1.5%96
28. Atrial fibrillationan irregular heart rhythm1.4%92
29. Drug-induced liver injury1.4%92
30. Arthralgiajoint pain1.4%90

Top 30 of 710 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 3 drugs in the cytochrome p450 17a1 inhibitor 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 37,351 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. 73% 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 6,436 reports.

Drugs most often listed in the same reports

Other products listed in reports where Abiraterone 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 cytochrome p450 17a1 inhibitor 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 Abiraterone as a suspect or interacting product; reports listing it only as a concomitant medication (1,664) 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.