Prescription medicine
Brodalumab Brand names: Siliq
Brodalumab (Siliq) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- 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 BLA 761032 record on Drugs@FDA; every brodalumab label on DailyMed.
Highlights of the record
FDA label of May 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SUICIDAL IDEATION AND BEHAVIOR.
Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes [see Warnings and Precautions ( 5.1 )]. Because of the observed suicidal behavior in subjects treated with SILIQ, SILIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program [see Warnings and Precautions ( 5.2 )]. WARNING: SUICIDAL IDEATION AND BEHAVIOR See full prescribing information for complete boxed warning.
Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. ( 5.1 , 6.1 )
Prior to prescribing, weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. ( 5.1 )
Patients with new or worsening suicidal thoughts and behavior should be referred to a mental health professional, as appropriate. […]
Used for
From the label: indications and usageSILIQ ® (brodalumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
Forms and strengths
- 210 mg
Injection.
On the market
- Earliest approval on file
- February 15, 2017 Siliq, Valeant Luxembourg; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,000 through July 30, 2026
What is brodalumab used for?
From the label: indications and usageSILIQ ® (brodalumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. SILIQ is a human interleukin-17 receptor A (IL-17RA) antagonist indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
Conditions named in the indications of brodalumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Interleukin-17 Receptor A Antagonist.
Source: FDA drug label (Siliq), 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 patient leaflet for brodalumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SILIQ?SILIQ may cause serious side effects, including: • Suicidal thoughts and behavior have happened in some people treated with SILIQ. Some people have ended their own lives. Your risk of suicidal thoughts and behavior may be increased if you have a history of suicidal thoughts or depression. It is not known if SILIQ causes suicidal thoughts and behavior. Get medical help right away or call the National Suicide and Crisis Lifeline at 988, if you or your caregiver notice in you any of the following symptoms: o new or worsening depression or anxiety o thoughts of suicide, dying, or hurting yourself o changes in behavior or mood o acting on dangerous impulses o attempt to commit suicide Because of your risk of suicidal thoughts and behavior during your treatment with SILIQ, SILIQ is available only through a restricted distribution program called the SILIQ Risk Evaluation and Mitigation Strategy (REMS ). […] Get medical help right away if you get any of the following signs or symptoms of a serious allergic reaction: o swelling of the face, lips, or tongue o trouble breathing or swallowing o itching o dizziness or feel faint o rash, hives, or redness all over your body o chest pain or tightness • Serious infections. SILIQ may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider will check you for tuberculosis (TB) before starting treatment with SILIQ and may treat you for TB before you begin treatment with SILIQ if you have a history of TB or have active TB. […]
From the patient leaflet: How should I store SILIQ?Store SILIQ prefilled syringe in the refrigerator at 36°F to 46°F (2°C to 8°C). • If needed, SILIQ prefilled syringe may be stored at room temperature up to 77°F (25°C) up to 14 days. Do not place SILIQ prefilled syringe stored at room temperature back into the refrigerator. • Throw away SILIQ prefilled syringe that has been stored at room temperature after 14 days. • Protect SILIQ prefilled syringe from heat. • Do not freeze. • Do not shake. • Keep SILIQ prefilled syringe in the original carton to protect from light and physical damage. Keep SILIQ and all medicines out of the reach of children.
Source: FDA drug label (Siliq), 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
Is there a generic for brodalumab (Siliq)?
No generic brodalumab is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the brodalumab label say about other medicines?
The brodalumab label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | drug interactions | … narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate [see Clinical Pharmacology ( 12.3 )]. |
| Ustekinumab | warnings and precautions | During the course of clinical trials for plaque psoriasis, the exposure-adjusted rates for infections and serious infections were similar in the subjects treated with SILIQ and those treated with ustekinumab. |
| Warfarin | drug interactions | Therefore, upon initiation or discontinuation of SILIQ in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of … |
Source: FDA drug label (Siliq), 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 for brodalumab?
The FDA Adverse Event Reporting System holds 2,000 reports that list brodalumab among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as brodalumab?
7 other medicines are given the same way (subcutaneous) and in the same FDA class as brodalumab or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Adalimumab-ryvk | Psoriasis | none listed | $499.12 per unit 40 mg/0.4 mL autoinjector | A presentation being discontinued |
| Risankizumab | Psoriasis | none listed | $22,774.36 per mL 150 mg/mL pen | No current entry |
| Bimekizumab | Psoriasis | none listed | $8,073.83 per mL 160 mg/mL autoinjector | No current entry |
| Ixekizumab | Psoriasis | none listed | $7,370.72 per mL 80 mg/mL autoinjector | No current entry |
| Secukinumab | Psoriasis | none listed | $3,946.35 per mL 300 mg dose/2 pens (150 mg/pen) | No current entry |
| Spesolimab | Psoriasis | none listed | n/a | No current entry |
| Tildrakizumab | Psoriasis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as brodalumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to brodalumab
- 7 medicines for the same use
- Brodalumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other