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What the label lists and what reports show

Elapegademase side effects

Elapegademase's FDA label: “The most common adverse reactions reported were cough (50%) and vomiting (33%).” FAERS holds 295 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nasopharyngitis (37 reports).

  • No generic listed

Check it at the source: the elapegademase FDA label on DailyMed (effective May 31, 2026); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions reported were cough (50%) and vomiting (33%).

From the label: adverse reactions, continued

The most common adverse reactions reported were cough (50%) and vomiting (33%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. REVCOVI was administered intramuscularly in two prospective, open-label, single-arm, multi‑center studies to evaluate efficacy, safety, tolerability, and pharmacokinetics in patients with ADA-SCID: Study 1 was performed in the US and Study 2 was performed in Japan [see Clinical Studies ( 14 )]. Overall, 10 patients were treated and adverse reactions reported are summarized below. Study 1 Study 1 is a one-way crossover study, conducted in the US, to evaluate the safety, efficacy, and pharmacokinetics of REVCOVI in patients with ADA‑SCID who were receiving therapy with Adagen. Six patients, 8 to 37 years of age enrolled in the study. Patients' exposure to REVCOVI ranged from 2 weeks to 146 weeks. No deaths were reported and one patient discontinued treatment due to injection site pain associated with an earlier drug product formulation that was consequently modified. …

Source: FDA drug label, Chiesi USA, Inc., effective May 31, 2026 (SPL set 8c073f84-cdd0-40e4-b3a9-172687267f28), via openFDA; the full label on DailyMed

What do FAERS reports show?

295 reports list elapegademase among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 44 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. Of the 22 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Nasopharyngitis37
  • Cough (named in the label)23
  • Covid-1922
  • Bone Marrow Transplant13
  • Sinusitis13
  • Pneumonia12
  • Weight Decreased12
  • Pyrexia11
  • Injection Site Pain10
  • Off Label Use (a use or a product term, not a reaction)10
  • Rhinorrhoea10
  • Diarrhoea (named in the label)8
  • Product Dose Omission (a use or a product term, not a reaction)8
  • Rash (named in the label)8
  • Weight Increased8
  • Influenza (named in the label)7
  • Viral Infection7
  • Decreased Appetite6
  • Headache6
  • Death (an outcome recorded in the report)5
  • Gastroenteritis Viral5
  • Infection (named in the label)5
  • Oropharyngeal Pain (named in the label)5
  • Respiratory Syncytial Virus Infection5
  • Dyspnoea4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Elapegademase: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions