Prescription medication · T-Cell Co-Stimulation Modulator

abatacept

Also sold as Orencia. Orencia treats rheumatoid arthritis in adults.

Data updated 2026-05-15

133,227
FDA reportsHeavily reported
5
InteractionsFew interactions
$1383.49
Brand price (NADAC)

What the data shows

abatacept (Orencia) is a prescription T-Cell Co-Stimulation Modulator, more reported than roughly 9 in 10 tracked drugs (133,227 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.

abatacept (Orencia) is a prescription T-Cell Co-Stimulation Modulator. Orencia treats rheumatoid arthritis in adults.

Orencia is a medicine that helps to reduce inflammation. It is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis.

Drug Pricing (NADAC)

Brand Price

$1383.49/unit

Generic Available

No

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

Compare with Another Drug → Full Side Effects Report →

What it does

Orencia treats rheumatoid arthritis in adults.

Common side effects

Headache, Upper respiratory tract infection (like a cold), Runny nose

Key warnings

Using Orencia with a TNF antagonist or other biologic medicines can raise your risk of serious infections.

The sections below are summarized in plain English from abatacept's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Orencia works by blocking the activity of certain immune cells called T cells. These T cells can cause inflammation and damage to your joints and other tissues. By blocking T cell activity, Orencia can help reduce inflammation and relieve your symptoms.

Side Effects (from patient reports)

Based on 133,227 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for abatacept, 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 abatacept each year to the FDA Adverse Event Reporting System (FAERS).

05,00010,00015,00020,000 20042007201020132016201920222025 9,524

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where abatacept sits

abatacept has more FDA adverse-event reports than 90% 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 abatacept; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 133,227 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

133,227

Reports Mentioning Death

8,659

6.5% of reports — not proof of cause

Hospitalization Reports

24,589

Top Indication

Rheumatoid Arthritis

Gender Distribution

Female 102,151 (85%)
Male 17,902 (15%)

Age Distribution

0–17 1,929
18–44 13,370
45–64 37,860
65–74 18,610
75+ 11,249

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
2 RHEUMATOID ARTHRITIS 23,596
3 PAIN 21,295
4 ARTHRALGIA 20,151
5 JOINT SWELLING 19,709
6 FATIGUE 14,200
7 CONTRAINDICATED PRODUCT ADMINISTERED 13,791
9 RASH 12,957
11 ARTHROPATHY 11,573
12 ALOPECIA 10,533
13 SYNOVITIS 10,151
14 ABDOMINAL DISCOMFORT 10,008
15 TREATMENT FAILURE 9,693
16 SWELLING 9,610
17 HYPERSENSITIVITY 9,413
18 HEADACHE 9,255

Reactions in Death Reports

DEATH 3,005
JOINT SWELLING 2,016
RHEUMATOID ARTHRITIS 2,013
INFUSION RELATED REACTION 1,966
PAIN 1,954
RASH 1,943
FATIGUE 1,892
HYPERTENSION 1,886
GLOSSODYNIA 1,883
SYSTEMIC LUPUS ERYTHEMATOSUS 1,857

Reactions in Hospitalization Reports

RHEUMATOID ARTHRITIS 5,521
PAIN 4,980
ARTHRALGIA 4,253
ARTHROPATHY 4,191
FATIGUE 4,089
RASH 4,069
SYNOVITIS 3,911
JOINT SWELLING 3,897
HYPERSENSITIVITY 3,446
DRUG HYPERSENSITIVITY 3,391

Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Using Orencia with a TNF antagonist or other biologic medicines can raise your risk of serious infections. Tell your doctor if you have any signs of infection, such as fever, cough, or sore throat. Orencia can also cause allergic reactions, including anaphylaxis. Get medical help right away if you have trouble breathing, swelling, or hives.

Known Drug Interactions

moderate adalimumab

7 DRUG INTERACTIONS • Abatacept: Increased risk of serious infection. 7.2 Biological Products In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of IDACIO with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions ( 5.7 , 5.11 )] . Concomitant administration of IDACIO with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk...

Mechanism: Both drugs lower your body's ability to fight germs. Taking them together increases your risk of getting a very serious infection without helping your symptoms more.

( 7.3 ) 7.1 Use with Anakinra, Abatacept, Rituximab, and Natalizumab An increased risk of serious infections has been seen in clinical studies of other TNF-blocking agents used in combination with anakinra or abatacept, with no added benefit. Therefore, the use of CIMZIA in combination with anakinra, abatacept, rituximab, or natalizumab is not recommended [see Warnings and Precautions (5.8) ] .

Mechanism: Both of these medicines weaken the immune system to treat inflammation, so taking them together makes it much harder for your body to fight off serious infections.

moderate etanercept

Live vaccines – Avoid concurrent administration with Enbrel ( 5.8 , 7.1 ) Anakinra – Increased risk of serious infection ( 5.12 , 7.2 ) Abatacept – Increased risk of serious adverse events, including infections ( 5.12 , 7.2 ) Cyclophosphamide – Not recommended for use with Enbrel. In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events, including infections, and did not demonstrate increased clinical benefit [see Warnings and Precautions (5.12) ] .

Mechanism: Both drugs lower your body's ability to fight off germs. Using them together makes your immune system too weak and greatly increases your risk of getting a serious infection.

moderate golimumab

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.

moderate infliximab

An increased risk of serious infections was seen in clinical studies of other TNF blockers used in combination with anakinra or abatacept, with no added clinical benefit. Because of the nature of the adverse reactions seen with these combinations with TNF blocker therapy, similar toxicities may also result from the combination of anakinra or abatacept with other TNF blockers. Therefore, the combination of INFLECTRA and anakinra or abatacept is not recommended [see Warnings and Precautions (5.10) ] .

Mechanism: Both drugs weaken the immune system, which makes it much harder for the body to fight off serious infections. Using them together does not provide any extra health benefits.

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I take Orencia with other medicines for my arthritis?
It is not recommended to take Orencia with TNF antagonists or JAK inhibitors.
What should I do if I have a reaction to Orencia?
If you have a serious allergic reaction, get medical help right away.
Can Orencia affect my blood sugar?
If you get Orencia through IV, it can cause falsely high blood sugar readings. If you monitor your blood sugar, use a method that does not react with maltose on the day of your infusion.
Do I need to be tested for TB before starting Orencia?
Yes, your doctor should screen you for latent TB infection before you start taking Orencia.
Can I get vaccines while taking Orencia?
Update your vaccinations before starting Orencia. Do not get live vaccines while taking Orencia or for 3 months after stopping it.
What are the most common side effects of Orencia?
The most common side effects are headache, upper respiratory infection, runny nose, and nausea.
How often do I take Orencia?
If you are taking Orencia through IV, you will get it at 0, 2, and 4 weeks, and then every 4 weeks. If you are taking Orencia through subcutaneous injection, you will inject it once a week.
How is Orencia supplied?
Orencia is available as a powder for intravenous infusion and as a solution in a prefilled syringe or autoinjector for subcutaneous injection.
What should I do if I miss a dose?
Take the missed dose as soon as you remember. Then, get back to your regular schedule.
How should I store Orencia?
Keep Orencia in the refrigerator.
What are the common side effects of abatacept?
The registry lists Headache, Upper respiratory tract infection (like a cold), Runny nose, Nausea among the most-reported FAERS reaction terms for abatacept. The compiled record contains 133,227 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does abatacept interact with other medications?
The registry has 5 documented interaction rows for abatacept. Notable source-record pairings include adalimumab, certolizumab, etanercept. These rows are not a complete medication review.
What drug class is abatacept?
abatacept belongs to the T-Cell Co-Stimulation Modulator drug class. It requires a prescription (Rx). Orencia treats rheumatoid arthritis in adults.
What pregnancy or breastfeeding source fields are listed for abatacept?
The FDA label for abatacept contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

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

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Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for abatacept: 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.

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What the FDA Data Shows for abatacept

The FDA label for abatacept (sold under brand names such as Orencia) classifies it as a prescription-only medication in the T-Cell Co-Stimulation Modulator class. Orencia treats rheumatoid arthritis in adults. Official labeling lists 4 commonly reported side effects, including Headache, Upper respiratory tract infection (like a cold), Runny nose.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 133,227 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: November 13, 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.

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