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.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$1383.49/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
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.
How to Take It
Orencia can be given as an intravenous (IV) infusion or as a subcutaneous (under the skin) injection. The dose depends on your weight and the condition being treated. If you get Orencia through IV, it will be given to you by a healthcare provider. If you use the subcutaneous injection, you will inject yourself once a week.
This is a plain-language summary of abatacept's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
There is not enough information about Orencia use in pregnant women to know if it is safe. Talk to your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
This is a plain-language summary of abatacept'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 Orencia, take it as soon as you remember. Then, get back to your regular schedule.
This is a plain-language summary of abatacept's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Keep Orencia in the refrigerator at 36°F to 46°F (2°C to 8°C).
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
- Rheumatoid arthritis
Rheumatoid arthritis
23,596 reports
- Pain
Pain
21,295 reports
- Joint pain
Joint pain
20,151 reports
- Swollen joint
Swollen joint
19,709 reports
- Tiredness
Tiredness
14,200 reports
- A medicine that should not be used was given
A medicine that should not be used was given
13,791 reports
- Skin rash
Skin rash
12,957 reports
- Joint disease
Joint disease
11,573 reports
- Hair loss
Hair loss
10,533 reports
- Inflammation of the joint lining
Inflammation of the joint lining
10,151 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 abatacept 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 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.
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
Age Distribution
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
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
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
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.
What to do: This combination is not recommended. Talk to your doctor about using a different treatment plan that only uses one of these drugs.
( 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.
What to do: This combination is not recommended and should be avoided because it increases the risk of infection without providing extra benefits.
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.
What to do: Avoid taking these two medications together. Your doctor will help you find a single treatment that works without increasing your risk of infection.
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.
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.
What to do: This combination is not recommended. Your doctor should avoid prescribing these two medications at the same time to prevent dangerous infections.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take Orencia with other medicines for my arthritis?
What should I do if I have a reaction to Orencia?
Can Orencia affect my blood sugar?
Do I need to be tested for TB before starting Orencia?
Can I get vaccines while taking Orencia?
What are the most common side effects of Orencia?
How often do I take Orencia?
How is Orencia supplied?
What should I do if I miss a dose?
How should I store Orencia?
What are the common side effects of abatacept?
Does abatacept interact with other medications?
What drug class is abatacept?
Is abatacept safe during pregnancy?
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Medication Guides
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Common Drug Interactions
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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 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: November 13, 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