Prescription medication · CYP17 Inhibitor
abiraterone
Also sold as Zytiga. Abiraterone is used to treat prostate cancer that has spread to other parts of the body.
- 12,794
- FDA reportsModerately reported
- 7
- InteractionsFew interactions
- $1.08
- Generic price (NADAC)
What the data shows
abiraterone (Zytiga) is a prescription CYP17 Inhibitor, reported less often than most tracked drugs (12,794 FDA reports), with 7 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
abiraterone (Zytiga) is a prescription CYP17 Inhibitor. Abiraterone is used to treat prostate cancer that has spread to other parts of the body.
Abiraterone (Zytiga) is a medicine used with prednisone to treat prostate cancer that has spread. It works by lowering the amount of androgen your body makes.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$1.08/unit
Generic Available
Yes (11 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Abiraterone is used to treat prostate cancer that has spread to other parts of the body.
Common side effects
Feeling tired, Joint pain, High blood pressure
Key warnings
Abiraterone can cause problems with mineralocorticoid excess, like high blood pressure, low potassium, and fluid retention.
The sections below are summarized in plain English from abiraterone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Abiraterone blocks an enzyme called CYP17, which your body needs to make androgens. Androgens can help prostate cancer grow. By blocking this enzyme, abiraterone lowers androgen levels and slows cancer growth.
How to Take It
Take abiraterone tablets once a day with prednisone. The typical dose is 1,000 mg of abiraterone and 5 mg of prednisone once or twice daily. Take abiraterone on an empty stomach. Do not eat anything for 2 hours before and 1 hour after taking it. Swallow the tablets whole with water; do not crush or chew them.
This is a plain-language summary of abiraterone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Abiraterone can cause harm to an unborn baby. Men who are taking abiraterone should use effective birth control during treatment and for 3 weeks after the last dose if their partner is able to get pregnant. It is not known if abiraterone passes into breast milk.
This is a plain-language summary of abiraterone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose of abiraterone, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of abiraterone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store abiraterone tablets at room temperature, away from heat and moisture, and keep out of reach of children.
Side Effects (from patient reports)
Based on 12,794 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for abiraterone, by number of reports
- Death
Death
1,390 reports
- Feeling tired
Feeling tired
1,022 reports
- Hot flash
Hot flash
678 reports
- Weakness
Weakness
562 reports
- Worsening of disease
Worsening of disease
561 reports
- Increased PSA levels 544
Increased PSA levels
544 reports
- Treatment stopped 453
Treatment stopped
453 reports
- Fall 434
Fall
434 reports
- Low red blood cell count 408
Low red blood cell count
408 reports
- Cancer worsening 391
Cancer worsening
391 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for abiraterone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where abiraterone sits
abiraterone has more FDA adverse-event reports than 44% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is abiraterone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 12,794 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2010–2025.
Total Reports
12,794
Reports Mentioning Death
2,176
17.0% of reports — not proof of cause
Hospitalization Reports
4,866
Top Indication
Prostate Cancer
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DEATH | 1,390 |
| 2 | FATIGUE | 1,023 |
| 3 | HOT FLUSH | 678 |
| 4 | ASTHENIA | 562 |
| 5 | DISEASE PROGRESSION | 561 |
| 6 | PROSTATIC SPECIFIC ANTIGEN INCREASED | 544 |
| 8 | THERAPY INTERRUPTED | 453 |
| 9 | FALL | 434 |
| 10 | ANAEMIA | 408 |
| 11 | MALIGNANT NEOPLASM PROGRESSION | 391 |
| 12 | DIARRHOEA | 388 |
| 13 | NAUSEA | 351 |
| 14 | PROSTATE CANCER | 351 |
| 15 | HYPOKALAEMIA | 346 |
| 16 | HYPERTENSION | 334 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Abiraterone can cause problems with mineralocorticoid excess, like high blood pressure, low potassium, and fluid retention. If you have heart problems, your doctor will monitor you closely. This medicine can also cause liver problems, which can be severe. Your doctor will check your liver function regularly. Do not take abiraterone with radium Ra 223 dichloride. Abiraterone can harm an unborn baby, so men should use effective birth control if their partner can get pregnant.
Known Drug Interactions
Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine).
Mechanism: Abiraterone interferes with the enzyme that breaks down thioridazine. Because thioridazine has a very narrow safety range, even a small increase in its levels could lead to dangerous side effects.
What to do: Avoid taking these two medications at the same time. Your healthcare provider should look for safer alternatives.
• Abiraterone: May increase prostate-specific antigen (PSA) levels ( 7.7 ). 7.7 Abiraterone Spironolactone binds to the androgen receptor and may increase prostate-specific antigen (PSA) levels in abiraterone-treated prostate cancer patients. Concomitant use of spironolactone and abiraterone is not recommended.
Mechanism: Spironolactone can interfere with the way abiraterone works against prostate cancer and may cause certain lab tests to show higher cancer markers. This makes it difficult for your doctor to track your progress.
What to do: It is recommended that you do not use these two medicines together. Talk to your healthcare provider about using a different treatment for your condition.
In a CYP2D6 drug-drug interaction trial, the C max and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily.
Mechanism: Taking these two drugs together can change how your liver processes other common medications, potentially causing those other drugs to build up in your system.
What to do: Your doctor should review all your other medicines to ensure their levels do not become too high while you are taking this combination.
In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone (CYP2C8 substrate) was increased by 46% when pioglitazone was given together with a single dose of 1,000 mg abiraterone acetate.
Mechanism: Abiraterone blocks a protein in the liver that normally breaks down pioglitazone. This causes pioglitazone to stay in your body longer and reach higher levels.
What to do: Your doctor may need to monitor you more closely for side effects or adjust your dose of pioglitazone.
In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone [see Clinical Pharmacology ( 12.3 )].
Mechanism: Ketoconazole does not change how your body processes abiraterone. There is no significant interaction between these two drugs.
What to do: You can take these medications together without any special changes to your treatment.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I do if I experience side effects?
Can I take abiraterone with food?
Will I need blood tests while taking this medicine?
What if I have liver problems?
Can abiraterone be used in women?
What if I am taking other medications?
How long will I need to take abiraterone?
Can I crush or chew the tablets?
What if I have diabetes?
Are there any contraindications?
What are the common side effects of abiraterone?
Does abiraterone interact with other medications?
What drug class is abiraterone?
Is abiraterone safe during pregnancy?
Related Medications in CYP17 Inhibitor
Other drugs grouped near abiraterone - same-class peers and common alternatives.
anastrozole
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bazedoxifene/conjugated estrogens
Duavee
Duavee is a combination medicine containing estrogen and a drug that blocks estrogen in some parts of the body.
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cabergoline
Dostinex
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clomiphene
Clomid, Serophene
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conjugated estrogens
Premarin
Premarin Intravenous is an injectable medicine that contains estrogen hormones.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for abiraterone
The FDA label for abiraterone (sold under brand names such as Zytiga) classifies it as a prescription-only medication in the CYP17 Inhibitor class. Abiraterone is used to treat prostate cancer that has spread to other parts of the body. Official labeling lists 12 commonly reported side effects, including Feeling tired, Joint pain, High blood pressure.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 12,794 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $1.08.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: March 17, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages