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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

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. ( 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 usage

Spherusol ® 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 usage

Spherusol ® 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 namedSectionWhat the label says
Epinephrinewarnings 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 …

Check coccidioides immitis spherule against other medicines

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