Prescription medication · TNF-Alpha Inhibitor (Biologic)
golimumab
Also sold as Simponi. Simponi Aria treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis.
Data updated 2026-05-15
- 82,622
- FDA reportsOften reported
- 5
- InteractionsFew interactions
- $6818.88
- Brand price (NADAC)
What the data shows
golimumab (Simponi) is a prescription TNF-Alpha Inhibitor (Biologic), more reported than most tracked drugs (82,622 FDA reports), with 5 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
golimumab (Simponi) is a prescription TNF-Alpha Inhibitor (Biologic). Simponi Aria treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis.
Simponi Aria is a medicine that blocks a protein called TNF. It is used to treat certain kinds of arthritis and a spine problem called ankylosing spondylitis.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$6818.88/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Simponi Aria treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis.
Common side effects
Upper respiratory infection (like a cold), Increased liver enzymes, Viral infection
Key warnings
Simponi Aria can increase your risk of serious infections that may lead to hospitalization or death.
The sections below are summarized in plain English from golimumab's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Simponi Aria is a TNF blocker. TNF is a protein in the body that can cause inflammation. By blocking TNF, Simponi Aria can reduce inflammation and relieve symptoms of arthritis and ankylosing spondylitis.
Side Effects (from patient reports)
Based on 82,622 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for golimumab, by number of reports
- Rheumatoid Arthritis
Rheumatoid Arthritis
14,100 reports
- Pain
Pain
13,403 reports
- Fatigue
Fatigue
11,277 reports
- Joint Swelling
Joint Swelling
9,729 reports
- Arthralgia
Arthralgia
9,679 reports
- Rash
Rash
9,305 reports
- Alopecia
Alopecia
9,271 reports
- Abdominal Discomfort
Abdominal Discomfort
8,672 reports
- Swelling
Swelling
8,472 reports
- Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
8,329 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 golimumab 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 golimumab sits
golimumab has more FDA adverse-event reports than 82% 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 golimumab; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 82,622 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2006–2025.
Total Reports
82,622
Reports Mentioning Death
5,919
7.2% of reports — not proof of cause
Hospitalization Reports
19,695
Top Indication
Rheumatoid Arthritis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | RHEUMATOID ARTHRITIS | 14,100 |
| 3 | PAIN | 13,403 |
| 4 | FATIGUE | 11,277 |
| 6 | JOINT SWELLING | 9,729 |
| 7 | ARTHRALGIA | 9,679 |
| 8 | RASH | 9,305 |
| 9 | ALOPECIA | 9,271 |
| 11 | ABDOMINAL DISCOMFORT | 8,672 |
| 12 | SWELLING | 8,472 |
| 13 | SYSTEMIC LUPUS ERYTHEMATOSUS | 8,329 |
| 14 | CONTRAINDICATED PRODUCT ADMINISTERED | 8,257 |
| 15 | PEMPHIGUS | 8,083 |
| 16 | GLOSSODYNIA | 7,911 |
| 17 | ARTHROPATHY | 7,632 |
| 18 | HYPERSENSITIVITY | 7,426 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Simponi Aria can increase your risk of serious infections that may lead to hospitalization or death. These include tuberculosis (TB) and fungal infections. You should be tested for TB before starting this medicine. Children and adolescents taking TNF blockers like Simponi Aria have a higher risk of lymphoma and other cancers, some of which have been fatal.
Known Drug Interactions
7 DRUG INTERACTIONS Biologics, including abatacept and anakinra: Increased risk of serious infections ( 5.1 , 5.6 , 5.7 , 5.8 , 7.2 ). 7.2 Biologic Products for RA, PsA, AS, and pJIA An increased risk of serious infections has been seen in clinical RA studies of other TNF-blockers used in combination with anakinra or abatacept, with no added benefit; therefore, use of SIMPONI ARIA with other biologic products, including abatacept or anakinra, is not recommended [see Warnings and Precautions (5.6 and 5.7) ] .
Mechanism: Both of these drugs weaken the immune system to treat inflammation. Using them together makes it much harder for your body to fight off serious infections without providing extra help for your condition.
Upon initiation or discontinuation of SIMPONI ARIA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.
Mechanism: This medicine can change how your body processes warfarin, which might make your blood thinner more or less effective.
7.1 Methotrexate SIMPONI ARIA should be used with MTX for the treatment of RA [see Clinical Studies (14.1) ] . Following IV administration, concomitant administration of methotrexate decreases the clearance of SIMPONI ARIA by approximately 9% based on population pharmacokinetics (PK) analysis. In addition, concomitant administration of methotrexate decreases the SIMPONI ARIA clearance by reducing the development of antibodies to golimumab.
Mechanism: Methotrexate makes golimumab last longer in your body by slowing its removal and stopping your immune system from attacking the drug.
Upon initiation or discontinuation of SIMPONI ARIA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.
Mechanism: Golimumab can change how your liver breaks down cyclosporine, which might change the amount of medicine in your blood.
Upon initiation or discontinuation of SIMPONI ARIA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.
Mechanism: Golimumab may interfere with the way your body processes theophylline, potentially changing its levels in your system.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What if I have an infection?
Can I get vaccines while taking Simponi Aria?
Will Simponi Aria cure my arthritis?
How long does it take for Simponi Aria to work?
Can I take other medicines with Simponi Aria?
What should I do if I have side effects?
How often will I receive Simponi Aria?
Can Simponi Aria affect my heart?
Is it safe to take Simponi Aria if I have hepatitis B?
Can Simponi Aria cause cancer?
What are the common side effects of golimumab?
Does golimumab interact with other medications?
What drug class is golimumab?
What pregnancy or breastfeeding source fields are listed for golimumab?
Related Medications in TNF-Alpha Inhibitor (Biologic)
Other drugs grouped near golimumab - same-class peers and common alternatives.
abatacept
Orencia
Orencia is a medicine that helps to reduce inflammation.
Compare with golimumab →
acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
Compare with golimumab →
acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
Compare with golimumab →
acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
Compare with golimumab →
adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
Compare with golimumab →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for golimumab: 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: 82,622.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.16%.
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on golimumab
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
What the FDA Data Shows for golimumab
The FDA label for golimumab (sold under brand names such as Simponi) classifies it as a prescription-only medication in the TNF-Alpha Inhibitor (Biologic) class. Simponi Aria treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. Official labeling lists 7 commonly reported side effects, including Upper respiratory infection (like a cold), Increased liver enzymes, Viral infection.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 82,622 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. 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 9, 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
- 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