Abiraterone
Abiraterone is an oral prostate cancer medicine, taken with a steroid, that lowers the hormones (androgens) that fuel the cancer. It is used for metastatic castration-resistant prostate cancer and, in some products, metastatic high-risk castration-sensitive prostate cancer.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 31 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Abiraterone, on the market since about 2010 and available as a generic, is a well-established tablet for prostate cancer that has spread, added to hormone-lowering treatment and taken with a steroid, and it blocks an enzyme (CYP17) that the testes, adrenal glands and the tumor itself use to make androgens, the male hormones that feed the cancer. Most people tolerate it reasonably well, and tiredness, hot flushes, joint aches and ankle swelling are what they notice most. The thing to watch is your liver, so call promptly about yellow skin or eyes, dark urine or severe belly pain, and keep up the frequent liver, blood pressure and potassium checks.
Clinical pearls
- Food greatly boosts absorption, so take Zytiga, Abirtega or generic tablets with no food 2 hours before or 1 hour after.
- Never skip or stop your steroid on your own, and ask about extra steroid during serious illness or major stress.
- If you take pioglitazone or repaglinide for diabetes, check your blood sugar more often, since severe lows have occurred.
- Pregnant women should not handle the tablets, and men need effective contraception until 3 weeks after the last dose.
Patient information guide A plain-language walkthrough of Abiraterone, written from its FDA label.
What Abiraterone is used for
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Abiraterone is used with a steroid to treat prostate cancer that has spread.
- Abiraterone acetate tablets, Abirtega and Zytiga (with prednisone): metastatic castration-resistant prostate cancer (CRPC).
- Abiraterone acetate tablets, Abirtega and Zytiga (with prednisone): metastatic high-risk castration-sensitive prostate cancer (CSPC).
- Yonsa (with methylprednisolone): metastatic CRPC only.
How Abiraterone works
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Abiraterone is turned into its active form in the body. It blocks CYP17, an enzyme needed to make androgens (hormones such as testosterone) in the testes, adrenal glands and prostate tumor tissue. Prostate cancer that depends on androgens responds when those levels drop.
Other hormone therapies, like GnRH agonists or orchiectomy, only reduce androgen production in the testes. Abiraterone also reduces androgens from the adrenals and tumor. Blocking CYP17 can raise mineralocorticoid hormones, which is why a steroid is taken with it.
Abiraterone dosage
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Abiraterone is a tablet taken by mouth once daily, together with a steroid. You also need a GnRH analog or prior orchiectomy.
- Abiraterone acetate tablets, Abirtega and Zytiga: take on an empty stomach, with no food 2 hours before and 1 hour after.
- Yonsa: take with or without food. Its dosing differs from other abiraterone products.
- Swallow tablets whole with water, and do not crush or chew.
Follow your prescriber and label for your exact dose and what to do if you miss one.
Dosing details from the FDA-approved label
From the Abiraterone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Metastatic castration-resistant prostate cancer (CRPC)
- 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily
- Take as a single dose once daily on an empty stomach; do not eat food 2 hours before and 1 hour after; swallow whole with water; do not crush or chew. Patients should also receive a GnRH analog concurrently or have had bilateral orchiectomy.
- Metastatic high-risk castration-sensitive prostate cancer (CSPC)
- 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg orally once daily
- Take as a single dose once daily on an empty stomach; do not eat food 2 hours before and 1 hour after; swallow whole with water. Patients should also receive a GnRH analog concurrently or have had bilateral orchiectomy.
- Baseline moderate hepatic impairment (Child-Pugh Class B)
- 250 mg once daily
- Monitor ALT, AST and bilirubin before treatment, every week for the first month, every two weeks for the following two months, and monthly thereafter. Discontinue and do not re-treat if ALT/AST greater than 5 x ULN or total bilirubin greater than 3 x ULN.
- Baseline severe hepatic impairment (Child-Pugh Class C)
- Do not use abiraterone acetate tablets
- Hepatotoxicity during treatment (ALT and/or AST greater than 5 x ULN or total bilirubin greater than 3 x ULN)
- Interrupt treatment
- May restart at a reduced dose of 750 mg once daily after liver tests return to baseline or to AST and ALT less than or equal to 2.5 x ULN and total bilirubin less than or equal to 1.5 x ULN. If hepatotoxicity recurs, may restart at 500 mg once daily after the same recovery
- If it recurs at 500 mg once daily, discontinue
- Monitor transaminases and bilirubin at least every two weeks for three months and monthly thereafter. Permanently discontinue if ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN occur concurrently without biliary obstruction or other cause.
- Concomitant strong CYP3A4 inducer that must be co-administered
- Increase dosing frequency to twice a day only during the co-administration period (e.g., from 1,000 mg once daily to 1,000 mg twice a day)
- Reduce back to the previous dose and frequency if the inducer is discontinued.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Metastatic castration-resistant prostate cancer: • Abiraterone acetate tablets 1,000 mg orally once daily with prednisone 5 mg orally twice daily. ( 2.1 ) Metastatic castration-sensitive prostate cancer: • Abiraterone acetate tablets 1,000 mg orally once daily with prednisone 5 mg orally once daily. ( 2.2 ) Patients receiving abiraterone acetate tablets should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Abiraterone acetate tablets must be taken as a single dose once daily on an empty stomach. Do not eat food 2 hours before and 1 hour after taking abiraterone acetate tablets. The tablets must be swallowed whole with water. Do not crush or chew tablets. ( 2.3 ) Dose Modification: • For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the abiraterone acetate tablets starting dose to 250 mg once daily. ( 2.4 ) • For patients who develop hepatotoxicity during treatment, hold abiraterone acetate tablets until recovery. Retreatment may be initiated at a reduced dose. Abiraterone acetate tablets should be discontinued if patients develop severe hepatotoxicity. ( 2.4 ) 2.1 Recommended Dose for Metastatic CRPC The recommended dose of abiraterone acetate tablets is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily. 2.2 Recommended Dose for Metastatic High-Risk CSPC The recommended dose of abiraterone acetate tablets is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg administered orally once daily. 2.3 Important Administration Instructions Patients receiving abiraterone acetate tablets should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Abiraterone acetate tablets must be taken as a single dose once daily on an empty stomach. Do not eat food 2 hours before and 1 hour after taking abiraterone acetate tablets. The tablets must be swallowed whole with water. Do not crush or chew tablets . 2.4 Dose Modification Guidelines in Hepatic Impairment and Hepatotoxicity Hepatic Impairment In patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the recommended dose of abiraterone acetate tablets to 250 mg once daily.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Abiraterone side effects
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Common side effects include:
Common side effects
- Tiredness (fatigue)
- Joint pain or swelling
- High blood pressure
- Nausea, vomiting or diarrhea
- Swelling from fluid retention (edema)
- Low potassium
- Hot flushes
- Cough, upper respiratory infection or headache
When to get medical help
- Call your doctor right away if you have signs of liver problems, such as yellowing of the skin or eyes, dark urine, or severe nausea or belly pain. Liver injury can be severe and even fatal.
- Get help for signs of low potassium, high blood pressure or fluid retention, such as muscle weakness, heart palpitations, new swelling or shortness of breath.
- Tell your doctor if you feel very weak, dizzy or faint, or become very ill. Adrenal insufficiency (the body not making enough steroid hormones) can occur, especially if you miss or stop your steroid, or during an infection or stress.
- Seek help for heart rhythm problems or heart failure symptoms. Rhythm changes, including QT prolongation and Torsades de Pointes, have been reported in people who develop low potassium.
- Report symptoms of low blood sugar if you have diabetes. Severe cases have occurred in people also taking pioglitazone or repaglinide.
Blood tests may also show anemia, high cholesterol or triglycerides, high blood sugar, or high liver enzymes. Call your doctor promptly about liver problems, heart symptoms, severe weakness or dizziness, or low blood sugar.
Abiraterone warnings and precautions
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- Liver toxicity: can be severe and fatal. It most often shows up in the first 3 months, so frequent blood tests are needed.
- Mineralocorticoid excess: can cause high blood pressure, low potassium and fluid retention. This is a particular concern with heart failure, a recent heart attack or rhythm problems.
- Adrenal insufficiency: a risk if the steroid is missed, reduced or stopped, or with infection or stress.
- Radium Ra 223 dichloride: combining it with abiraterone plus prednisone raised fractures and deaths in a trial and is not recommended.
- Embryo-fetal harm: it can harm an unborn baby.
- Low blood sugar: severe cases were reported with pioglitazone or repaglinide.
Abiraterone interactions
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Some medicines change how abiraterone works, or how it changes other drugs.
- Strong CYP3A4 inducers (such as rifampin): can cut abiraterone levels by about 55%, so avoid them if possible.
- CYP2D6 drugs with a narrow safety margin (such as thioridazine): abiraterone raises their levels, so avoid them or lower their dose.
- Pioglitazone: levels rose about 46%, and low blood sugar can occur, so watch closely.
- Repaglinide: low blood sugar risk, so monitor glucose.
- Radium Ra 223 dichloride: not recommended together.
- Food: greatly increases absorption, so follow the fasting directions for your product.
Interactions listed in the FDA-approved label
From the Abiraterone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital): Rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant use; if one must be co-administered, increase the abiraterone acetate dosing frequency to twice a day only during co-administration.
- Strong CYP3A4 inhibitors (ketoconazole): Ketoconazole had no clinically meaningful effect on the pharmacokinetics of abiraterone.
- CYP2D6 substrates (e.g., thioridazine, dextromethorphan): Abiraterone inhibits CYP2D6; dextromethorphan Cmax and AUC were increased 2.8- and 2.9-fold. Avoid co-administration with CYP2D6 substrates with a narrow therapeutic index; if an alternative cannot be used, consider a dose reduction of the substrate.
- CYP2C8 substrates (pioglitazone): Abiraterone inhibits CYP2C8; the AUC of pioglitazone was increased by 46%. Monitor closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index.
- CYP1A2 substrates (theophylline): No increase in systemic exposure of theophylline was observed.
Read the label’s full interactions text
7 DRUG INTERACTIONS • CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers during abiraterone acetate tablets treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate tablets dosing frequency. ( 2.5 , 7.1 ) • CYP2D6 Substrates: Avoid co-administration of abiraterone acetate tablets with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate. ( 7.2 ) 7.1 Drugs that Inhibit or Induce CYP3A4 Enzymes Based on in vitro data, abiraterone acetate tablets are a substrate of CYP3A4. In a dedicated drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during abiraterone acetate tablets treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate tablets dosing frequency [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] . 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) ] . 7.2 Effects of Abiraterone on Drug Metabolizing Enzymes Abiraterone acetate tablets are an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. 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. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) ] .
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Abiraterone
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- Severe liver impairment (Child-Pugh Class C): do not use. Moderate impairment calls for a lower starting dose.
- Heart disease, heart failure, recent heart attack, rhythm problems, high blood pressure or low potassium: need control and close monitoring.
- Diabetes: blood sugar should be monitored, especially with pioglitazone or repaglinide.
- Pregnancy: it can cause fetal harm. Men with partners who could become pregnant should use effective contraception during treatment and for 3 weeks after. Women who are or may become pregnant should not handle the tablets.
- Breastfeeding: no information is available, and safety in females has not been established.
- Fertility: it may impair fertility in men.
- Children: safety and effectiveness have not been established.
- Older adults: no overall differences were seen, though some may be more sensitive.
- Kidney impairment: no dose change is needed.
Abiraterone overdose
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Experience with overdose is limited, and there is no specific antidote. If too much is taken, abiraterone should be stopped. Care is supportive, including monitoring for heart rhythm problems and heart failure and checking liver function.
What Abiraterone does in the body
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Abiraterone lowers testosterone and other androgens. Because it affects hormones, it can raise mineralocorticoid levels, causing blood pressure and potassium changes. In a small study, no large change in the heart's QTc interval was seen, though a small increase could not be ruled out. PSA changes may occur but do not reliably show benefit in an individual patient.
How your body processes Abiraterone
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Abiraterone acetate is converted in the body to active abiraterone, which peaks in about 2 hours. Food sharply raises absorption, which is why the fasting directions matter for some products. The average half-life is about 12 hours. It is cleared mostly in the feces (about 88%) and a small amount in urine (about 5%). Moderate or severe liver impairment raises abiraterone levels substantially.
How to store Abiraterone
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) . Keep out of reach of children.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Abiraterone
181 supplements and herbal products have documented interactions with Abiraterone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 137
- Minor · 38
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Abiraterone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Abiraterone — the kind of thing our pharmacy team would talk through with you at the counter.
What is abiraterone for?
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How should I take it, and does food matter?
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Why do I need to take a steroid with it?
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What side effects are common, and which should I call about?
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Are there medicines I should watch out for?
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Is it safe around pregnancy?
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Is Abiraterone available over the counter?
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When was Abiraterone first available?
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Who makes Abiraterone?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Abiraterone on HelloPharmacist
Abiraterone forms and strengths (how it comes)
Abiraterone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Abiraterone acetate tablets, Abirtega and Zytiga are used with prednisone for metastatic CRPC and metastatic high-risk CSPC.
- Yonsa is used with methylprednisolone for metastatic CRPC.
- Abiraterone acetate tablets, Abirtega and Zytiga are taken once daily on an empty stomach: no food 2 hours before or 1 hour after.
- Yonsa is taken once daily with or without food. Its dosing and food effects may differ from other abiraterone products, so avoid mixing up products.
- For all of these tablets, swallow whole with water. Do not crush or chew.
Abiraterone on the U.S. market: products, makers and brands
How Abiraterone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
23 companies list 43 Abiraterone product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2010. Brand names on the directory include Zytiga, Yonsa, Abirtega; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (30) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Abiraterone is used (Medicaid data)
A general measure of how commonly Abiraterone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Abiraterone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Abiraterone prescribed? Of the 1,601 medications we measure, Abiraterone ranks #861 by Medicaid prescriptions — more than 46% of them.
Utilization by Abiraterone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
abiraterone acetate 250 MG Oral Tablet Most dispensed
Summed across the 14 of 42 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1100075
abiraterone acetate 500 MG Oral Tablet
Summed across the 11 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1918042
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Abiraterone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 25 of 64 listed Abiraterone NDCs with Medicaid activity.
Compare Abiraterone products
A representative set of FDA-listed product records for Abiraterone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 250 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 250 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 500 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 250 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 500 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 250 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 500 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 250 mg | Oral | AvKARE | ANDA | View NDC → |
| 500 mg | Oral | AvKARE | ANDA | View NDC → |
| 250 mg | Oral | AvPAK | ANDA | View NDC → |
| 250 mg | Oral | BluePoint Laboratories | ANDA | View NDC → |
| 500 mg | Oral | BluePoint Laboratories | ANDA | View NDC → |
| 500 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 250 mg | Oral, Oral | CivicaScript, LLC | ANDA | View NDC → |
| 250 mg | Oral | CivicaScript, LLC | ANDA | View NDC → |
| 250 mg | Oral | Dr. Reddys Laboratories Inc × 2 listings | ANDA | View NDC → |
| 500 mg | Oral | Dr. Reddys Laboratories Inc | ANDA | View NDC → |
| 500 mg | Oral | Florida Pharmaceutical Products, LLC | ANDA | View NDC → |
| 250 mg | Oral | Florida Pharmaceutical Products, LLC. | ANDA | View NDC → |
| 250 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 500 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 125 mg | Oral | Golden State Medical Supply, Inc. | NDA | View NDC → |
| 500 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 250 mg | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 250 mg | Oral | Janssen Biotech, Inc. | NDA | View NDC → |
| 500 mg | Oral | Janssen Biotech, Inc. | NDA | View NDC → |
| 250 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 250 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 500 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 250 mg | Oral | Northstar Rx Llc × 2 listings | ANDA | View NDC → |
| 500 mg | Oral | Northstar Rx Llc | ANDA | View NDC → |
| 250 mg | Oral | Novadoz Pharmaceuticals LLC × 2 listings | ANDA | View NDC → |
| 500 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 250 mg | Oral | Novugen Pharma (USA) LLC | ANDA | View NDC → |
| 500 mg | Oral | Novugen Pharma (USA) LLC | ANDA | View NDC → |
| 250 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 250 mg | Oral | Quallent Pharmaceuticals Health LLC | ANDA | View NDC → |
| 500 mg | Oral | Quallent Pharmaceuticals Health LLC | ANDA | View NDC → |
| 250 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 125 mg | Oral | Sun Pharmaceutical Industries, Inc. | NDA | View NDC → |
Showing 43 of 43 products — FDA National Drug Code Directory. See every product, package size and price: browse all 43 Abiraterone NDCs →
Abiraterone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Abiraterone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Abiraterone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Abiraterone FDA approval history
How Abiraterone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Abiraterone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Abiraterone recalls since July 2021.
✅No Abiraterone recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1100072 1 dose form · 3 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 1100074In current FDA listingsClinical drug / strength (SCD) acetate 125 MGRxCUI 2046579acetate 250 MGRxCUI 1100075acetate 500 MGRxCUI 1918042
Look up RxCUI 1100072 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Abiraterone supply and shortage status
Whether Abiraterone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Abiraterone costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 250 mg | $0.774 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 500 mg | $2.59 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 250 mg | $0.774 per tablet | NDC details & price history |
| Tablet · Oral; Oral | 250 mg | $0.774 per tablet | NDC details & price history |
| Tablet · Oral, Oral | 250 mg | $0.774 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Abiraterone brand names
Abiraterone is sold under 3 brand names in the FDA directory — Zytiga, Yonsa, Abirtega. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Abiraterone: manufacturers and labelers
23 companies list Abiraterone products with the FDA. By number of product records, the largest are Amneal Pharmaceuticals NY LLC, Dr. Reddys Laboratories Inc, Northstar Rx Llc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Abiraterone drug class (RxNorm)
Abiraterone belongs to the Cytochrome P450 17A1 Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Abiraterone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. American Health Packaging is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →