Prescription medicine
Anidulafungin Brand names: Eraxis
Anidulafungin (Eraxis) is a prescription medicine with an FDA approval on record since 2006. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the anidulafungin FDA label on DailyMed (effective August 19, 2025, Roerig); the NDA 21632 record on Drugs@FDA; every anidulafungin label on DailyMed.
Highlights of the record
FDA label of August 19, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageERAXIS is an echinocandin antifungal indicated for the treatment of the following infections:
Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) ( 1.1 )
Esophageal candidiasis in adults ( 1.2 ) Limitations of use
ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and men
Forms and strengths
- 50 mg/15ml
- 100 mg/30ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- February 17, 2006 Eraxis, Vicuron Holdings; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
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
- 1,600 through July 30, 2026
What is anidulafungin used for?
From the label: indications and usageERAXIS is an echinocandin antifungal indicated for the treatment of the following infections:
Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) ( 1.1 )
Esophageal candidiasis in adults ( 1.2 ) Limitations of use
ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established. ( 1.3 , 5.3 , 8.4 )
ERAXIS is associated with high relapse rates in esophageal candidiasis. […]
Conditions named in the indications of anidulafungin's FDA labels, with every medicine labeled for each:
From other anidulafungin labelsFungal infections: Esophageal Candidiasis ERAXIS is indicated for the treatment of esophageal candidiasis in adults [see Indications and Usage (1.3), Clinical Studies (14.2) ].
FDA pharmacologic class: Echinocandin Antifungal.
Source: FDA drug label (ERAXIS), NDA021632 (Vicuron Holdings), as published by Roerig, effective August 19, 2025 (SPL set a88d9010-55fb-4a02-baff-042cd27688ea), via openFDA; the full label on DailyMed
Is there a generic for anidulafungin (Eraxis)?
No generic anidulafungin is approved (Drugs@FDA, October 8, 2026).
- 2006 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the anidulafungin label say about other medicines?
The anidulafungin label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amphotericin b | drug interactions | Liposome for Injection Administration of multiple doses of anidulafungin and liposomal amphotericin B to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin. |
| Cyclosporine | drug interactions | DRUG INTERACTIONS 7.1 Cyclosporine Administration of multiple doses of anidulafungin and cyclosporine to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. |
| Rifampin | drug interactions | Administration of multiple doses of anidulafungin and rifampin to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin. |
| Tacrolimus | drug interactions | Administration of multiple doses of anidulafungin and a single-dose of tacrolimus to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. |
| Voriconazole | drug interactions | Administration of multiple doses of anidulafungin and voriconazole to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. |
Source: FDA drug label (ERAXIS), NDA021632 (Vicuron Holdings), as published by Roerig, effective August 19, 2025 (SPL set a88d9010-55fb-4a02-baff-042cd27688ea), via openFDA; the full label on DailyMed
What do FAERS reports show for anidulafungin?
The FDA Adverse Event Reporting System holds 1,600 reports that list anidulafungin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 688 are coded as a death and 770 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as anidulafungin?
6 other medicines are given the same way (intravenous) and in the same FDA class as anidulafungin or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Micafungin | Fungal infections | 10 labelers | n/a | A presentation being discontinued |
| Caspofungin | Fungal infections | 5 labelers | n/a | A presentation being discontinued |
| Voriconazole | Fungal infections | 12 labelers | n/a | A presentation being discontinued |
| Fluconazole | Fungal infections | 4 labelers | n/a | No current entry |
| Posaconazole | Fungal infections | 7 labelers | n/a | A presentation being discontinued |
| Amphotericin b | Fungal infections | 5 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as anidulafungin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to anidulafungin
- 6 medicines for the same use
- Other echinocandin antifungals
- the pharmacologic class, with prices and generics
- Anidulafungin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other