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PlainMeds

Prescription medicine

Conestat alfa Brand names: Ruconest

Conestat alfa (Ruconest) is a prescription medicine. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the conestat alfa FDA label on DailyMed (effective April 30, 2020); every conestat alfa label on DailyMed.

Highlights of the record

FDA label of April 30, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

Forms and strengths

Injection (powder) for 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
FAERS reports
6,234 through July 30, 2026

What is conestat alfa used for?

From the label: indications and usage

RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks. RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). ( 1 ) Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks.

Source: FDA drug label (Ruconest), Pharming Healthcare Inc., effective April 30, 2020 (SPL set 66d3fecb-32a4-7781-e053-2a91aa0a83ca), via openFDA; the full label on DailyMed

Is there a generic for conestat alfa (Ruconest)?

No generic conestat alfa is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for conestat alfa?

The FDA Adverse Event Reporting System holds 6,234 reports that list conestat alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 24 are coded as a death and 1,278 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

  • Hereditary Angioedema (a use or a product term, not a reaction)1,014
  • Intentional Product Use Issue (a use or a product term, not a reaction)764
  • Drug Ineffective For Unapproved Indication (a use or a product term, not a reaction)510
  • Drug Ineffective (a use or a product term, not a reaction)450
  • Condition Aggravated (a use or a product term, not a reaction)428
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)406
  • Pharyngeal Swelling360
  • Weight Decreased245

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Conestat alfa side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other