What development phase is FOSDENOPTERIN HYDROBROMIDE in?

FOSDENOPTERIN HYDROBROMIDE is FDA-approved (marketed).

What are the side effects of FOSDENOPTERIN HYDROBROMIDE?

Common side effects include Catheter-related complications, Pyrexia, Viral infection, Pneumonia, Otitis media, Vomiting.

Last reviewed 2026-05-14 · How we verify

FOSDENOPTERIN HYDROBROMIDE

FDA-approved approved Small molecule Quality 0/100

At a glance

Generic name	FOSDENOPTERIN HYDROBROMIDE
Modality	Small molecule
Phase	FDA-approved
First approval	2021

Approved indications

No approved indications tracked.

Common side effects

Catheter-related complications
Pyrexia
Viral infection
Pneumonia
Otitis media
Vomiting
Cough/Sneezing
Upper viral respiratory infection
Gastroenteritis
Diarrhea
Bacteremia
Abdominal pain

Serious adverse events

Necrotizing enterocolitis
Sepsis
Oral candidiasis
Varicella
Fungal skin infection

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

FOSDENOPTERIN HYDROBROMIDE CI brief — competitive landscape report
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