What the label lists and what reports show
Spesolimab side effects
Spesolimab's FDA label: “The most common adverse reactions (≥5%) are asthenia and fatigue, headache, nausea, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection.” FAERS holds 371 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 generalised pustular psoriasis (68 reports).
- No generic listed
Check it at the source: the spesolimab FDA label on DailyMed (effective April 8, 2026); 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 SPEVIGO?SPEVIGO may cause serious side effects. See " What is the most important information I should know about SPEVIGO? " The most common side effects of SPEVIGO for GPP flare treatment include: feeling tired or weak headache nausea itching or itchy bumps a collection of blood under the skin at the infusion site or bruising urinary tract infection The most common side effects of SPEVIGO for treatment of GPP when not experiencing a flare include: redness, pain, swelling, hardening, hives, or warmth at the injection site urinary tract infection joint pain itching These are not all of the possible side effects of SPEVIGO. 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, Boehringer Ingelheim Pharmaceuticals, Inc., effective April 8, 2026 (SPL set 41a481ee-3062-45d1-aed5-17e8b105634d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥5%) are asthenia and fatigue, headache, nausea, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection.
Table 1 Selected Adverse Reactions Occurring in ≥1% of the Intravenous SPEVIGO Group and More Frequently than in the Placebo Group through Week 1 in Subjects with GPP Flare (Study Effisayil-1)
| Adverse Reaction | Intravenous SPEVIGO N = 35 n (%) | Placebo N = 18 n (%) |
|---|---|---|
| Asthenia and Fatigue | 3 (9) | 1 (6) |
| Headache | 3 (9) | 1 (6) |
| Nausea | 2 (6) | 0 |
| Pruritus and prurigo | 2 (6) | 0 |
| Infusion site hematoma and bruising | 2 (6) | 0 |
| Urinary tract infection | 2 (6) | 0 |
| Bacteremia | 1 (3) | 0 |
| Bacteriuria | 1 (3) | 0 |
| Cellulitis | 1 (3) | 0 |
| Herpes dermatitis and oral herpes | 1 (3) | 0 |
| Upper respiratory tract infection | 1 (3) | 0 |
| Dyspnea | 1 (3) | 0 |
| Eye edema | 1 (3) | 0 |
| Urticaria | 1 (3) | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: Infections [see Warnings and Precautions (5.1) ] Hypersensitivity and Infusion-Related Reactions [see Warnings and Precautions (5.3) ] Treatment of GPP When Not Experiencing a Flare: SPEVIGO has been associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus. ( 6.1 ) Treatment of GPP Flare: The most common adverse reactions (≥5%) are asthenia and fatigue, headache, nausea, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 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, Boehringer Ingelheim Pharmaceuticals, Inc., effective April 8, 2026 (SPL set 41a481ee-3062-45d1-aed5-17e8b105634d), via openFDA; the full label on DailyMed
What do FAERS reports show?
371 reports list spesolimab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 24 are coded as a death and 81 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, 10 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Spesolimab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions