What the label lists and what reports show
Brodalumab side effects
Brodalumab's FDA label: “Most common adverse reactions (incidence ≥1%) were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections.” FAERS holds 2,000 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 arthralgia (191 reports).
- No generic listed
- Boxed warning
Check it at the source: the brodalumab FDA label on DailyMed (effective May 28, 2026, Bausch Health US LLC); 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 SILIQ?SILIQ may cause serious side effects. • See “What is the most important information I should know about SILIQ?” • Severe skin reactions that look like eczema can happen during treatment with SILIQ from days to months after your first dose and can sometimes lead to hospitalization. Your healthcare provider may temporarily stop treatment with SILIQ if you develop severe skin reactions. Tell your healthcare provider if you have any of the following signs or symptoms: o redness or rash o itching o small bumps or patches o your skin is dry or feels like leather o blisters on the hands or feet that ooze or become crusty o skin peeling • Crohn’s disease. Tell your healthcare provider if you develop diarrhea, painful diarrhea, bloody stools, stomach pain or cramping, sudden or uncontrollable bowel movements, loss of appetite, constipation, weight loss, fever, or tiredness. […]
Source: FDA drug label, BLA761032 (Valeant Luxembourg), as published by Bausch Health US LLC, effective May 28, 2026 (SPL set 1a550c33-456a-4833-814e-8591aea7c688), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥1%) were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections.
Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects in the SILIQ Group and More Frequently than in the Placebo Group in Plaque Psoriasis Trials through Week 12
| Adverse Reactions | Placebo (N=879) n (%) | SILIQ 210 mg every 2 weeks Subjects receiving 210 mg of SILIQ at Weeks 0, 1, and 2,… | Ustekinumab (N=613) Trials 2 and 3 included the active comparator, ustekinumab. n (%) |
|---|---|---|---|
| Arthralgia | 29 (3.3) | 71 (4.7) | 15 (2.4) |
| Headache | 31 (3.5) | 64 (4.3) | 23 (3.8) |
| Fatigue | 10 (1.1) | 39 (2.6) | 16 (2.6) |
| Diarrhea | 10 (1.1) | 33 (2.2) | 5 (0.8) |
| Oropharyngeal pain | 10 (1.1) | 31 (2.1) | 8 (1.3) |
| Nausea | 10 (1.1) | 28 (1.9) | 6 (1.0) |
| Myalgia | 3 (0.3) | 26 (1.7) | 4 (0.7) |
| Injection site reactions | 11 (1.3) | 23 (1.5) | 12 (2.0) |
| Influenza | 4 (0.5) | 19 (1.3) | 7 (1.1) |
| Neutropenia | 4 (0.5) | 15 (1.0) | 5 (0.8) |
| Tinea infections | 2 (0.2) | 15 (1.0) | 3 (0.5) |
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 serious adverse reactions are discussed in greater detail in other sections of labeling: • Suicidal Ideation and Behavior [see Warnings and Precautions ( 5.1 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] • Infections [see Warnings and Precautions ( 5.4 )] • Crohn’s Disease [see Contraindications ( 4 ), Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence ≥1%) were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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. The overall safety population included 4,558 subjects (3,066 SILIQ, 613 ustekinumab, 879 placebo) in controlled clinical trials and open-label extension studies. The majority of subjects were male (69%), white (91%), and aged 40-64 years old (58%). One third of subjects reported previous biologic use prior to enrollment. …
Source: FDA drug label, BLA761032 (Valeant Luxembourg), as published by Bausch Health US LLC, effective May 28, 2026 (SPL set 1a550c33-456a-4833-814e-8591aea7c688), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,000 reports list brodalumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 139 are coded as a death and 564 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 16 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.
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?
- Brodalumab: 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