Drugs › Cytochrome P450 17A1 inhibitor
Generic name
Abiraterone acetate: adverse event reports filed with FDA
5,656 reports list it as a suspect or interacting product, 2010–2026. Class: Cytochrome P450 17A1 inhibitor. Also reported as Abiraterone Acetate 250mg Tab, Abiraterone Acetate Tablet, Abiraterone Acetate 250mg.
- 5,656
- reports as suspect product
- 0% of all reports · about 350 a year
- 456
- reports, 12 months to June 2026
- 493 in the 12 months before
- 88.1%
- marked serious by the reporter
- 68.2% across the class
- 18.8%
- record death among outcomes, as reported
- 1,065 reports · not verified by FDA
Between May 2010 and June 2026, 5,656 adverse event reports received by FDA list abiraterone acetate, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (798) are left out of every figure here.
In the 12 months to June 2026, 456 reports listed it, close to the 493 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 350 reports a year and 0% of the 20,646,523 reports in the database, and 15.1% of the reports for the cytochrome P450 17A1 inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded death (11.1%), fatigue (5.6%) and hypokalaemia (4.1%). A report can list several reactions, so shares add to more than 100%; 664 different terms appear across these reports. Death is recorded in 11.1% of these reports, about the same share as in the median cytochrome P450 17A1 inhibitor drug (11.1%).
88.1% of the reports are marked serious by the reporter (68.2% across the class); 18.8% record death among the outcomes and 48.6% record hospitalisation, as reported. 34.4% of the reports came from other health professionals, and the largest patient age group is 75 and over (31.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 acetate reports recording the termmedian drug in cytochrome p450 17a1 inhibitor
- Deaththe patient died; cause not stated by this term11.1%629
- Fatiguetiredness5.6%318
- Hypokalaemialow blood potassium4.1%230
- Anaemialow red blood cells3.7%212
- Astheniaweakness or lack of energy3.7%208
- Disease progressionthe disease advanced3.4%192
- Pneumonialung infection3.3%187
- Hypertensionhigh blood pressure3.3%185
- Drug ineffectivethe medicine did not work as expected3.2%181
- Diarrhoealoose or frequent stools3.2%179
- Falla fall3.1%173
- Therapy interrupted2.9%165
- Urinary tract infectionbladder or urinary infection2.7%155
- Nauseafeeling sick2.7%153
- Prostate cancer2.7%152
- Acute kidney injurysudden loss of kidney function2.7%151
- Dyspnoeashortness of breath2.4%135
- Vomitingbeing sick2.2%124
- Hospitalisationadmission to hospital2.1%120
- Prostate cancer metastatic2.1%120
- Drug interactionan interaction between medicines2%115
- Decreased appetitereduced appetite1.9%108
- Dizzinesslight-headedness or unsteadiness1.9%106
- Sepsisa severe body-wide response to infection1.9%106
- Back painback pain1.9%105
- Thrombocytopenialow platelets1.8%103
- Hot flusha hot flush1.8%102
- Atrial fibrillationan irregular heart rhythm1.7%98
- Alanine aminotransferase increasedraised liver enzyme (ALT)1.7%94
Top 30 of 664 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 55.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Prostate cancer | 2,505 | 44.3% |
| Prostate cancer metastatic | 1,171 | 20.7% |
| Hormone-refractory prostate cancer | 404 | 7.1% |
| Hormone-dependent prostate cancer | 120 | 2.1% |
| Neoplasm malignant | 28 | 0.5% |
| Metastases to bone | 20 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 5,656 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Abiraterone acetate reports |
|---|---|---|
| Prednisone | 2,065 | 36.5% |
| Prednisolone | 771 | 13.6% |
| Aspirin | 461 | 8.2% |
| Enzalutamide | 418 | 7.4% |
| Amlodipine | 314 | 5.6% |
| Atorvastatin | 281 | 5% |
| Docetaxel | 249 | 4.4% |
| Ergocalciferol | 233 | 4.1% |
| Omeprazole | 222 | 3.9% |
| Lisinopril | 221 | 3.9% |
Other products listed in reports where Abiraterone acetate 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
| Measure | Abiraterone acetate | Cytochrome P450 17A1 inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 5,656 | 37,351 | 20,646,523 |
| Share of that pool | — | 15.1% | 0% |
| Reports, latest 12 months | 456 | — | 1,332,454 |
| Marked serious | 88.1% | 68.2% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 188 | 206 | 91 |
| Hospitalisation recorded, per 1,000 reports | 486 | 270 | 213 |
| Consumer-filed share | 17.4% | 32.9% | 45.8% |
| Top term, share of reports | Death 11.1% | median 11.1% | 4.1% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Zytiga | brand | 25,259 | 183 | 63.4% |
| Abiraterone | generic | 6,436 | 615 | 69.9% |
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.
Questions about Abiraterone acetate reports
How many adverse event reports has FDA received for Abiraterone acetate?
5,656 reports list Abiraterone acetate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 456 of them arrived in the latest 12 months. Another 798 list it only as a concomitant medication.
What reactions are recorded in Abiraterone acetate reports?
death (11.1%), fatigue (5.6%), hypokalaemia (4.1%), anaemia (3.7%) and asthenia (3.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Abiraterone acetate was responsible.
How serious are the reports?
88.1% are marked serious by the reporter. Among the outcomes recorded, 18.8% of reports include death and 48.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (34.4%), physician (34.2%) and consumer or non-health professional (17.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Abiraterone acetate rising?
456 reports in the 12 months to June 2026, close to the 493 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Abiraterone acetate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Abiraterone acetate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 acetate as a suspect or interacting product; reports listing it only as a concomitant medication (798) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.