Prescription medicine
Coccidioides immitis spherule
Coccidioides immitis spherule is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the coccidioides immitis spherule FDA label on DailyMed (effective January 14, 2025); every coccidioides immitis spherule label on DailyMed.
Highlights of the record
FDA label of January 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
The expected response to Spherusol ® is a local area of inflammation at the site of the skin test. The reaction is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur, which may require treatment with local cold compresses and anti-inflammatory medication. ( 2.3 , 6.1 ) Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or cause death. Emergency measures and personnel trained in their use should be immediately available. Patients should be observed for at least 20 minutes following the administration of a skin test. ( 6.2 ) Spherusol ® should never be given intravenously. ( 5 ) To report SUSPECTED ADVERSE REACTIONS, contact Nielsen BioSciences, Inc. at (855) 855-1212 or MEDWATCH, Food and Drug Administration (FDA), 5600 Fishers Lane, Rockville, MD 20852-9782. Telephone: (800) 332-1088 or www.vaers.hhs.gov. ( 6.2 ) WARNING See full prescribing information for complete boxed warning The expected response to Spherusol ® is a local area of inflammation at the site of the skin test. The reaction is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur, which may require treatment with local cold compresses and anti-inflammatory medication. […]
Used for
From the label: indications and usageSpherusol ® is a skin test antigen indicated for the detection of delayed-type hypersensitivity to Coccidioides immitis in individuals with a history of pulmonary coccidioidomycosis.
Forms and strengths
Injection (solution).
On the market
- 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
What is coccidioides immitis spherule used for?
From the label: indications and usageSpherusol ® is a skin test antigen indicated for the detection of delayed-type hypersensitivity to Coccidioides immitis in individuals with a history of pulmonary coccidioidomycosis. Spherusol ® is approved for use in individuals 18-64 years of age. The use of Spherusol ® to detect delayed-type hypersensitivity responses in a general population with unknown exposure to C. immitis has not been evaluated. Persons with acute or disseminated coccidioidomycosis may not develop a delayed-type hypersensitivity response to Spherusol ® . Persons with immunodeficiency and a history of coccidioidomycosis may not develop a delayed-type hypersensitivity response to Spherusol ® . […]
FDA pharmacologic class: Skin Test Antigen.
Source: FDA drug label (Spherusol), Nielsen BioSciences, Inc., effective January 14, 2025 (SPL set 77108624-4771-4886-a3e2-b2625c444d1b), via openFDA; the full label on DailyMed
Is there a generic for coccidioides immitis spherule?
No generic coccidioides immitis spherule is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the coccidioides immitis spherule label say about other medicines?
The coccidioides immitis spherule label names 1 other medicine 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 |
|---|---|---|
| Epinephrine | warnings and precautions | … administration of Spherusol ® . ( 5.1 ) Patients receiving beta-blocking drugs may be refractive to the usual dose of epinephrine in cases of hypersensitivity. ( 5.2 ) Any condition or agent that impairs or attenuates delayed type hypersensitivity reactions, including infections and use of immunosuppressive drugs, can … |
Source: FDA drug label (Spherusol), Nielsen BioSciences, Inc., effective January 14, 2025 (SPL set 77108624-4771-4886-a3e2-b2625c444d1b), via openFDA; the full label on DailyMed
What next?
- Other skin test antigens
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other