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.

Verify with FDA → · CMS NADAC pricing →

Drug Pricing (NADAC)

Brand Price

$13350.90/unit

Generic Available

No

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

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.

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

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.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for guselkumab each year to the FDA Adverse Event Reporting System (FAERS).

02,0004,0006,0008,000 2016201720182019202020212022202320242025 6,638

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.

fewest reports most reports

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

Female 14,702 (59%)
Male 10,393 (41%)

Age Distribution

0–17 544
18–44 4,797
45–64 7,645
65–74 2,139
75+ 947

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

DEATH 256
PNEUMONIA 22
COVID-19 19
SEPSIS 15
SEPTIC SHOCK 14
HEPATIC CIRRHOSIS 13
INFECTION 12
DYSPNOEA 11
MYOCARDIAL INFARCTION 8
CARDIAC ARREST 7

Reactions in Hospitalization Reports

PNEUMONIA 277
PSORIASIS 146
HOSPITALISATION 106
COVID-19 104
PSORIATIC ARTHROPATHY 76
DYSPNOEA 69
PYREXIA 67
FALL 62
INFECTION 60
SEPSIS 59

Source: 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?
Tell your doctor about all your medical conditions, including any infections, liver problems, or if you are pregnant or breastfeeding.
Can I get vaccines while taking Tremfya?
Avoid live vaccines while taking Tremfya. Talk to your doctor before getting any vaccines.
How will Tremfya be given to me?
Tremfya is given as a shot under the skin (subcutaneous injection) or as an intravenous infusion, depending on the condition being treated.
What are the symptoms of an allergic reaction?
Symptoms of an allergic reaction can include hives, difficulty breathing, and swelling of the face, lips, tongue, or throat.
What should I do if I think I have an infection?
Contact your doctor right away if you think you have an infection while taking Tremfya.
Will Tremfya interact with other medications I am taking?
Tremfya may affect how other medicines work. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How long does it take for Tremfya to start working?
It may take several weeks or months for Tremfya to start working. Talk to your doctor if you don't see any improvement in your symptoms.
Can Tremfya cure my condition?
Tremfya can help manage your condition, but it is not a cure.
What if I can't afford Tremfya?
Contact the manufacturer of Tremfya to see if they have any patient assistance programs that can help you afford your medication.
Where on my body should I inject Tremfya?
Your doctor or nurse will show you the best places to inject Tremfya. You can inject it into your thigh, stomach area (abdomen), or upper arm.
What are the common side effects of guselkumab?
The registry lists Upper respiratory infections (like a cold), Headache, Injection site reactions (redness, pain, or swelling), Joint pain, Bronchitis among the most-reported FAERS reaction terms for guselkumab. The compiled record contains 31,164 FDA adverse-event reports. These counts are not an individual symptom assessment.
What drug class is guselkumab?
guselkumab belongs to the Anti-IL-23 Monoclonal Antibody drug class. It requires a prescription (Rx). Tremfya treats moderate to severe plaque psoriasis in adults and children 6 years and older who weigh at least 88 pounds.
What pregnancy or breastfeeding source fields are listed for guselkumab?
The FDA label for guselkumab contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

Related Medications in Anti-IL-23 Monoclonal Antibody

Other drugs grouped near guselkumab - same-class peers and common alternatives.

adapalene

Differin

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apremilast

Otezla

Apremilast (Otezla/Otezla XR) is a medicine that can help adults and children manage psoriatic arthritis and psoriasis.

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azelaic acid

Finacea, Azelex

Azelaic acid gel is a topical medicine that helps treat rosacea.

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benzoyl peroxide

Benzac, PanOxyl

Benzoyl peroxide is a topical medicine that fights germs on your skin.

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betamethasone

Diprosone, Luxiq

Betamethasone dipropionate cream is a strong steroid medicine used on the skin.

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Compare guselkumab vs adapalene side-by-side →

Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for guselkumab: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

Similar FAERS report volume

Nearest drugs by total FAERS reports. This record: 31,164.

4 peers

Similar death-report share

Nearest drugs by FAERS death-report share. This record: 1.30%.

4 peers

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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

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. This registry does not provide medication decisions.

Last updated: September 29, 2025

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page