Prescription medicine
Atrasentan Brand names: Vanrafia
Atrasentan (Vanrafia) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the atrasentan FDA label on DailyMed (effective June 12, 2026, Novartis Pharmaceuticals Corporation); the NDA 219208 record on Drugs@FDA; every atrasentan label on DailyMed.
Highlights of the record
FDA label of June 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
EMBRYO-FETAL TOXICITY.
VANRAFIA is contraindicated for use in pregnant patients; it may cause major birth defects based on animal data [see Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1)]. Exclude pregnancy prior to initiation of treatment with VANRAFIA. Advise use of effective contraception before the initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with VANRAFIA. Stop VANRAFIA as soon as possible if the patient becomes pregnant [see Dosage and Administration (2.1), Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)]. WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. VANRAFIA may cause major birth defects if used during pregnancy ( 4.1 , 5.1 , 8.1 ) Exclude pregnancy before start of treatment. ( 2.1 , 4.1 , 5.1 , 8.3 ) Use effective contraception before start of treatment, during treatment and two weeks after treatment. ( 4.1 , 5.1 , 8.3 ) Discontinue VANRAFIA if pregnancy occurs.
Used for
From the label: indications and usageVANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.
Forms and strengths
- 0.75 mg
Film-coated tablet.
On the market
- Earliest approval on file
- April 2, 2025 Vanrafia, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 25, 2043 Vanrafia tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 82 through July 30, 2026
What is atrasentan used for?
From the label: indications and usageVANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. This indication is approved under accelerated approval based on a reduction of proteinuria [see Clinical Studies (14.1)]. It has not been established whether VANRAFIA slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. […]
FDA pharmacologic class: Endothelin Receptor Antagonist.
Source: FDA drug label (VANRAFIA), Novartis Pharmaceuticals Corporation, effective June 12, 2026 (SPL set 9a7e7f85-bfd0-44a0-beda-3bcfa8215c64), via openFDA; the full label on DailyMed
What does the patient leaflet for atrasentan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VANRAFIA?VANRAFIA can cause serious birth defects if taken during pregnancy. Females should not be pregnant when they start taking VANRAFIA or become pregnant during treatment with VANRAFIA or for two weeks after stopping treatment with VANRAFIA. Females who can become pregnant should have a negative pregnancy test before starting VANRAFIA. Females who can become pregnant are those who: have entered puberty, even if they have not started their menstrual period, and have a uterus, and have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed. Females who cannot become pregnant are those who: have not yet entered puberty, or do not have a uterus, or have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or are infertile for any other medical reason and this infertility is permanent and cannot be reversed. Females who can become pregnant should use effective birth control before starting treatment with VANRAFIA, during treatment with VANRAFIA and for 2 weeks after stopping VANRAFIA because the medicine may still be in your body. Talk with your healthcare provider or gynecologist (a healthcare provider who specializes in reproduction) to find out about options for effective forms of birth control that you may use to prevent pregnancy during treatment with VANRAFIA. If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another effective form of birth control. Do not have unprotected sex. […]
From the patient leaflet: How should I store VANRAFIA?Store VANRAFIA at room temperature between 68°F to 77°F (20°C to 25°C). Store VANRAFIA in the original container. The bottle has a child-resistant cap and contains a desiccant to help keep the tablets dry. Keep VANRAFIA and all medicines out of the reach of children.
Source: FDA drug label (VANRAFIA), Novartis Pharmaceuticals Corporation, effective June 12, 2026 (SPL set 9a7e7f85-bfd0-44a0-beda-3bcfa8215c64), via openFDA; the full label on DailyMed
Is there a generic for atrasentan (Vanrafia)?
No generic atrasentan is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 10 patents for Vanrafia tablets, the last expiring on March 25, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2043 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the atrasentan label say about other medicines?
The atrasentan label names no other medicine on this site. The labels of 1 other medicine name atrasentan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name atrasentan
Source: FDA drug label (VANRAFIA), Novartis Pharmaceuticals Corporation, effective June 12, 2026 (SPL set 9a7e7f85-bfd0-44a0-beda-3bcfa8215c64), via openFDA; the full label on DailyMed
What do FAERS reports show for atrasentan?
The FDA Adverse Event Reporting System holds 82 reports that list atrasentan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 12 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other endothelin receptor antagonists
- the pharmacologic class, with prices and generics
- Atrasentan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other