Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (derived from potato). abiraterone-chem-structure

What kind of drug is abiraterone?

The FDA classifies abiraterone as a cytochrome p450 17a1 inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take abiraterone with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run abiraterone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is abiraterone sold under?

We track 3 abiraterone-containing products in the U.S.: Abiraterone Acetate, Yonsa and Zytiga. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does abiraterone come in?

Across the brands we track, abiraterone is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic abiraterone?

Yes. Our catalog lists 1 generic abiraterone product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Abiraterone: uses, dosing, side effects & brands

Abiraterone is a cytochrome p450 17a1 inhibitor sold in the U.S. under 3 brand and generic names, for castration-resistant prostatic neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesHow we research

Key facts

Drug class: Cytochrome P450 17a1 Inhibitor
Treats: Castration-Resistant Prostatic Neoplasms
Available as: Tablet
Sold as: 3 products — Abiraterone Acetate, Yonsa and Zytiga
Prescription?: Prescription only
Generic available?: Yes
Typical price: about $26 for a 30-count supply

How abiraterone is dosed

From the FDA label for Abiraterone Acetate (application ANDA208339). Other abiraterone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

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 (four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily. 2.2 Recommended Dose for…

Abiraterone side effects

The following are discussed in more detail in other sections of the labeling: • Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess [see Warnings and Precautions (5.1) ] . • Adrenocortical Insufficiency [see Warnings and Precautions (5.2) ] . • Hepatotoxicity [see Warnings and Precautions (5.3) ]. • Increased Fractures and Mortality in Combination with Radium Ra 223 Dichloride [see Warnings and Precautions (5.4) ] . The most common adverse reactions (≥10%) are fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache. ( 6.1 ) The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Two randomized placebo-controlled, multicenter clinical trials (COU-AA-301 and COU-AA-302)…

Every abiraterone product we track (3)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Abiraterone products
#	Drug	Rating	Type	Form	Generic?	Typical price
1	Abiraterone Acetate	70/100	Prescription	Tablet	Generic	$26	View →
2	Yonsa	Not yet rated	Prescription	Tablet	Generic	$26

What abiraterone pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Abiraterone pill imprints
Imprint	Strength	Colour	Shape	Maker
N;50;A	50 mg / 500 mg	brown	oval	—
N;100;A	100 mg / 500 mg	brown	oval	—
125;FP	125 mg	white	oval	—
G;135	250 mg	white	oval	—
G;121	500 mg	brown	oval	—
35	250 mg

Combination products containing abiraterone

A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.

Akeega

Frequently asked questions

What is abiraterone?: Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (derived from potato). abiraterone-chem-structure
What kind of drug is abiraterone?: The FDA classifies abiraterone as a cytochrome p450 17a1 inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take abiraterone with other medicines?: It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run abiraterone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is abiraterone sold under?: We track 3 abiraterone-containing products in the U.S.: Abiraterone Acetate, Yonsa and Zytiga. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does abiraterone come in?

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.