What the label lists and what reports show
Risankizumab side effects
Risankizumab's FDA label: “Most common adverse reactions are: Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.” FAERS holds 81,290 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 pain (3,225 reports).
- No generic listed
Check it at the source: the risankizumab FDA label on DailyMed (effective June 15, 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 SKYRIZI?SKYRIZI may cause serious side effects including: See “What is the most important information I should know about SKYRIZI?” Liver problems may happen while being treated for Crohn’s disease or ulcerative colitis. A person with Crohn’s disease who received SKYRIZI by intravenous infusion (through a vein in the arm) developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and at least up to 12 weeks of treatment with SKYRIZI. Your healthcare provider may stop treatment with SKYRIZI if you develop liver problems. […]
Source: FDA drug label, AbbVie Inc., effective June 15, 2026 (SPL set 7148c8eb-b39e-e20a-6494-a6df82392858), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions are: Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
Table 6. Adverse Reactions Reported in >3% of Subjects with Crohn’s Disease Treated with SKYRIZI a in Placebo-Controlled 52-Week Maintenance Trial (CD-3)
| Adverse Drug Reactions | SKYRIZI 180 mg Subcutaneous Injection N = 155 n (%) | SKYRIZI 360 mg Subcutaneous Injection N = 142 n (%) | Placebo N = 143 n (%) |
|---|---|---|---|
| Arthralgia | 13 (8.4) | 13 (9.2) | 12 (8.4) |
| Abdominal pain b | 9 (5.8) | 12 (8.5) | 6 (4.2) |
| Injection site reactions c,d | 7 (4.5) | 8 (5.6) | 4 (2.8) |
| Anemia | 7 (4.5) | 7 (4.9) | 6 (4.2) |
| Pyrexia | 4 (2.6) | 7 (4.9) | 4 (2.8) |
| Back pain | 3 (1.9) | 6 (4.2) | 3 (2.1) |
| Arthropathy | 1 (0.6) | 5 (3.5) | 2 (1.4) |
| Urinary tract infection | 1 (0.6) | 5 (3.5) | 4 (2.8) |
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 other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Most common adverse reactions are: Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. ( 6.1 ) Crohn’s Disease (>3%): ◦ Induction: upper respiratory infections, headache, and arthralgia. ( 6.1 ) ◦ Maintenance: arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. ( 6.1 ) Ulcerative Colitis (≥3%): ◦ Induction: arthralgia. ( 6.1 ) ◦ Maintenance: arthralgia, pyrexia, injection site reactions, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 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 drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, AbbVie Inc., effective June 15, 2026 (SPL set 7148c8eb-b39e-e20a-6494-a6df82392858), via openFDA; the full label on DailyMed
What do FAERS reports show?
81,290 reports list risankizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,905 are coded as a death and 18,119 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 rose sharply in 2025 (19,570, against a median of 1,931 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 11 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.
Reports received each year
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?
- Risankizumab: 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