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What the label lists and what reports show

Delgocitinib side effects

Delgocitinib's FDA label lists its adverse reactions in its own words. FAERS holds 233 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 pruritus (26 reports).

  • No generic listed

Check it at the source: the delgocitinib FDA label on DailyMed (effective July 10, 2026, LEO Pharma, Inc); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of ANZUPGO?

ANZUPGO may cause serious side effects, including: See " What is the most important information I should know about ANZUPGO? " The most common side effects of ANZUPGO include: application site reactions, including pain, tingling, itching, and redness bacterial skin infections, including finger cellulitis, and nail infections low white blood cells These are not all of the possible side effects of ANZUPGO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Source: FDA drug label, LEO Pharma, Inc, effective July 10, 2026 (SPL set a59bf36e-6f04-4b47-b385-8040c95f040c), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Adverse reactions that were reported in ≤ 1% of subjects were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 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 clinical practice. …

Source: FDA drug label, LEO Pharma, Inc, effective July 10, 2026 (SPL set a59bf36e-6f04-4b47-b385-8040c95f040c), via openFDA; the full label on DailyMed

What do FAERS reports show?

233 reports list delgocitinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 35 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 17 reactions below, 5 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

  • Product Use In Unapproved Indication (a use or a product term, not a reaction)56
  • Pruritus (named in the label)26
  • Dermatitis Atopic25
  • Dermatitis20
  • Erythema (named in the label)20
  • Drug Ineffective (a use or a product term, not a reaction)18
  • Rash14
  • Eczema (a use or a product term, not a reaction)11
  • Skin Burning Sensation10
  • Burning Sensation8
  • Dry Skin (named in the label)8
  • Erythema Multiforme8
  • Off Label Use (a use or a product term, not a reaction)7
  • Skin Exfoliation7
  • Product Dose Omission Issue (a use or a product term, not a reaction)6
  • Cellulitis (named in the label)5
  • Condition Aggravated (a use or a product term, not a reaction)5
  • Dyshidrotic Eczema5
  • Drug Ineffective For Unapproved Indication (a use or a product term, not a reaction)4
  • Headache4
  • Herpes Zoster (named in the label)4
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)4
  • Injection Site Pain4
  • Product Administered At Inappropriate Site4
  • Pyrexia4

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

What next?

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