golimumab
Brand names: Simponi
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.
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.
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.
How to Take It
Simponi Aria is given as an IV infusion by a healthcare provider. Adults usually get 2 mg per kg of body weight. The infusion is given over 30 minutes. You will get the infusion at weeks 0 and 4, and then every 8 weeks.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Simponi Aria can cross the placenta and may affect your baby's immune system. Live vaccines are not recommended for infants exposed to Simponi Aria in the womb for 6 months after the mother's last dose.
Missed Dose
Call your doctor right away if you miss an infusion appointment. They will reschedule your appointment as soon as possible.
Storage
Keep Simponi Aria in the refrigerator, protected from light, in its original carton. Do not freeze or shake it. If needed, it may be stored at room temperature for up to 30 days.
Side Effects (from patient reports)
Based on 116,609 FDA adverse event reports.
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
Death-Related Reports
5,919
Hospitalization Reports
19,695
Top Indication
Rheumatoid Arthritis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 21,070 |
| 2 | RHEUMATOID ARTHRITIS | 14,100 |
| 3 | PAIN | 13,403 |
| 4 | FATIGUE | 11,277 |
| 5 | OFF LABEL USE | 9,986 |
| 6 | JOINT SWELLING | 9,729 |
| 7 | ARTHRALGIA | 9,679 |
| 8 | RASH | 9,305 |
| 9 | ALOPECIA | 9,271 |
| 10 | DRUG INTOLERANCE | 8,790 |
| 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 |
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
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.
What to do: This combination is not recommended. Talk to your doctor about using only one of these biologic treatments at a time.
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.
What to do: Your doctor should monitor your blood tests closely and may need to adjust your warfarin dose when you start or stop this drug.
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.
What to do: These drugs are often used together, but your doctor will monitor your treatment to ensure it is working correctly.
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.
What to do: Your doctor should check your blood levels of cyclosporine and may adjust your dose when starting or stopping golimumab.
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.
What to do: Your doctor should monitor your theophylline levels and may adjust your dose when you start or stop taking golimumab.
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?
Is golimumab safe during pregnancy?
Related Medications in TNF-Alpha Inhibitor (Biologic)
Other drugs grouped near golimumab — same-class peers and common alternatives.
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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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
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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 116,609 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 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 9, 2025
Read our methodology — how this data is sourced, computed, and verified.
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