Prescription medication · Anti-IL-23 Monoclonal Antibody
guselkumab
Also sold as Tremfya. Tremfya treats moderate to severe plaque psoriasis in adults and children 6 years and older who weigh at least 88 pounds.
Data updated 2026-05-15
- 31,164
- FDA reportsModerately reported
- $13350.90
- Brand price (NADAC)
guselkumab (Tremfya) is a prescription Anti-IL-23 Monoclonal Antibody. Tremfya treats moderate to severe plaque psoriasis in adults and children 6 years and older who weigh at least 88 pounds.
Tremfya is a medicine that can help treat plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease. It works by blocking a protein in your body that causes inflammation.
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Drug Pricing (NADAC)
Brand Price
$13350.90/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Tremfya treats moderate to severe plaque psoriasis in adults and children 6 years and older who weigh at least 88 pounds.
Common side effects
Upper respiratory infections (like a cold), Headache, Injection site reactions (redness, pain, or swelling)
Key warnings
Tremfya can cause serious allergic reactions, including anaphylaxis, which can be life-threatening.
The sections below are summarized in plain English from guselkumab's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Tremfya is a type of medicine called an interleukin-23 antagonist. It blocks a protein called IL-23 in your body. IL-23 causes inflammation, so blocking it can help reduce the symptoms of psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease.
How to Take It
For plaque psoriasis or psoriatic arthritis, the dose is 100 mg given as a shot under the skin. You'll get your first shot at Week 0, another at Week 4, and then every 8 weeks. For ulcerative colitis or Crohn's disease, you may receive an intravenous infusion or a subcutaneous injection. Your doctor will determine the best dosage and schedule for you.
This is a plain-language summary of guselkumab's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Tremfya will harm your unborn baby. There is a pregnancy registry to monitor outcomes in women exposed to Tremfya during pregnancy. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu.
This is a plain-language summary of guselkumab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose of Tremfya, inject it as soon as you remember. Then, continue with your regular schedule.
This is a plain-language summary of guselkumab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Tremfya in the refrigerator between 36°F and 46°F (2°C to 8°C) in its original carton to protect it from light. Do not freeze or shake it.
Side Effects (from patient reports)
Based on 31,164 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for guselkumab, by number of reports
- Accidental exposure to the medicine
Accidental exposure to the medicine
3,138 reports
- Psoriasis
Psoriasis
2,066 reports
- Problem with the needle
Problem with the needle
2,054 reports
- Problem with the device
Problem with the device
1,748 reports
- Device not working properly
Device not working properly
1,480 reports
- Medicine stored incorrectly 1,121
Medicine stored incorrectly
1,121 reports
- Problem using the device 973
Problem using the device
973 reports
- Taking the medicine at the wrong times 897
Taking the medicine at the wrong times
897 reports
- Joint pain 839
Joint pain
839 reports
- Device leaking 791
Device leaking
791 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for guselkumab each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where guselkumab sits
guselkumab has more FDA adverse-event reports than 65% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is guselkumab; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 31,164 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2016–2025.
Total Reports
31,164
Reports Mentioning Death
404
1.3% of reports — not proof of cause
Hospitalization Reports
2,350
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | ACCIDENTAL EXPOSURE TO PRODUCT | 3,138 |
| 4 | PSORIASIS | 2,066 |
| 5 | NEEDLE ISSUE | 2,054 |
| 6 | DEVICE ISSUE | 1,748 |
| 7 | DEVICE MALFUNCTION | 1,480 |
| 9 | PRODUCT STORAGE ERROR | 1,121 |
| 10 | DEVICE DEPLOYMENT ISSUE | 973 |
| 11 | INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 897 |
| 12 | ARTHRALGIA | 839 |
| 13 | DEVICE LEAKAGE | 791 |
| 14 | PNEUMONIA | 788 |
| 15 | PRODUCT LEAKAGE | 733 |
| 16 | DRUG DELIVERY SYSTEM MALFUNCTION | 707 |
| 17 | DEVICE DEFECTIVE | 681 |
| 18 | UNDERDOSE | 672 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Tremfya can cause serious allergic reactions, including anaphylaxis, which can be life-threatening. Tell your doctor right away if you have any signs of an allergic reaction, like hives, trouble breathing, or swelling of your face, lips, tongue, or throat. Tremfya may also increase your risk of getting infections, including tuberculosis (TB). Your doctor should check you for TB before you start taking Tremfya and monitor you for signs of TB during and after treatment. Tremfya can also cause liver problems. Your doctor should check your liver enzyme and bilirubin levels before you start taking Tremfya and periodically during treatment.
Common Questions
What should I tell my doctor before taking Tremfya?
Can I get vaccines while taking Tremfya?
How will Tremfya be given to me?
What are the symptoms of an allergic reaction?
What should I do if I think I have an infection?
Will Tremfya interact with other medications I am taking?
How long does it take for Tremfya to start working?
Can Tremfya cure my condition?
What if I can't afford Tremfya?
Where on my body should I inject Tremfya?
What are the common side effects of guselkumab?
What drug class is guselkumab?
Is guselkumab safe during pregnancy?
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What the FDA Data Shows for guselkumab
The FDA label for guselkumab (sold under brand names such as Tremfya) classifies it as a prescription-only medication in the Anti-IL-23 Monoclonal Antibody class. Tremfya treats moderate to severe plaque psoriasis in adults and children 6 years and older who weigh at least 88 pounds. Official labeling lists 13 commonly reported side effects, including Upper respiratory infections (like a cold), Headache, Injection site reactions (redness, pain, or swelling).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 31,164 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: September 29, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages