Prescription medicine
Guselkumab Brand names: Tremfya
Guselkumab (Tremfya) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $14,728.91 per mL (Tremfya 100 mg/mL syringe) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the guselkumab FDA label on DailyMed (effective June 4, 2026, Janssen Biotech, Inc.); the BLA 761061 record on Drugs@FDA; every guselkumab label on DailyMed.
Highlights of the record
FDA label of June 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy.
Forms and strengths
- 100 mg/ml
- 200 mg/20ml
- 200 mg/2ml
Injection.
On the market
- Earliest approval on file
- July 13, 2017 Tremfya, Janssen Biotech; Drugs@FDA’s file, where older or withdrawn approvals can be missing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)
- $14,728.91 per mL Tremfya 100 mg/mL syringe
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 9, 2021
- FAERS reports
- 35,559 through July 30, 2026
What is guselkumab used for?
From the label: indications and usageTREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. ( 1.2 ) adults with moderately to severely active ulcerative colitis. ( 1.3 ) adults with moderately to severely active Crohn's disease. […]
Conditions named in the indications of guselkumab's FDA labels, with every medicine labeled for each:
From other guselkumab labelsCrohn's disease and ulcerative colitis: Ulcerative Colitis TREMFYA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
FDA pharmacologic class: Interleukin-23 Antagonist.
Source: FDA drug label (TREMFYA), Janssen Biotech, Inc., effective June 4, 2026 (SPL set 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56), via openFDA; the full label on DailyMed
What does the patient leaflet for guselkumab 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 TREMFYA?TREMFYA may cause serious side effects, including: Serious allergic reactions. Stop using TREMFYA and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue or throat trouble breathing or throat tightness chest tightness skin rash, hives itching Infections. TREMFYA is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA and may treat you for TB before you begin treatment with TREMFYA if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills cough shortness of breath blood in your phlegm (mucus) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA. With the treatment of plaque psoriasis or psoriatic arthritis, your healthcare provider may do blood tests to check your liver before and as necessary during treatment with TREMFYA. Your healthcare provider may stop treatment with TREMFYA if you develop liver problems. […]
From the patient leaflet: How should I store TREMFYA?Store TREMFYA in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C). Keep TREMFYA in the original carton to protect it from light until time of use. TREMFYA is not made with natural rubber latex. Do not freeze TREMFYA. Do not shake TREMFYA. Keep TREMFYA and all medicines out of the reach of children.
Source: FDA drug label (TREMFYA), Janssen Biotech, Inc., effective June 4, 2026 (SPL set 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56), via openFDA; the full label on DailyMed
Is there a generic for guselkumab (Tremfya)?
No generic guselkumab is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for guselkumab (Tremfya)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $14,728.91 per mL (Tremfya 100 mg/mL syringe), up 5% from $14,073.73 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tremfya 200 mg/2 mL pen (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tremfya 100 mg/mL one-press | Brand | $14,743.72 per mL | n/a | +5% |
| Tremfya 100 mg/mL pen | Brand | $14,620.07 per mL | n/a | n/a |
| Tremfya 100 mg/mL syringe | Brand | $14,728.91 per mL | n/a | +5% |
| Tremfya 200 mg/2 mL pen | Brand | $7,321.66 per mL | $14,643.31 per pen | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has guselkumab been recalled?
The FDA's Enforcement Report lists 1 recall naming guselkumab since 2021: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 9, 2021 | Class III | Cardinal Health Inc. | Temperature Abuse |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for guselkumab?
The FDA Adverse Event Reporting System holds 35,559 reports that list guselkumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 458 are coded as a death and 2,667 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 (6,819, against a median of 2,193 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 guselkumab?
4 other medicines are given the same way (subcutaneous) and in the same FDA class as guselkumab or labeled mainly for the same use (crohn's disease and ulcerative colitis), the same class first. Crohn's disease and ulcerative colitis lists all 29 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 |
|---|---|---|---|---|
| Ustekinumab | Crohn's disease and ulcerative colitis | none listed | $29,874.45 per mL 45 mg/0.5 mL syringe | No current entry |
| Ustekinumab-aekn | Crohn's disease and ulcerative colitis | none listed | n/a | No current entry |
| Risankizumab | Crohn's disease and ulcerative colitis | none listed | $22,774.36 per mL 150 mg/mL pen | No current entry |
| Ustekinumab-srlf | Crohn's disease and ulcerative colitis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as guselkumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does guselkumab compare with medicines for the same use?
1 side-by-side page set guselkumab beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to guselkumab
- 4 medicines for the same use
- Other interleukin-23 antagonists
- the pharmacologic class, with prices and generics
- Guselkumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other