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abatacept

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Brand names: Orencia

T-Cell Co-Stimulation Modulator Rx

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 →

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.

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.

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.

Missed Dose

If you miss a dose of Orencia, take it as soon as you remember. Then, get back to your regular schedule.

Storage

Keep Orencia in the refrigerator at 36°F to 46°F (2°C to 8°C).

Side Effects (from patient reports)

Based on 189,045 FDA adverse event reports.

The medicine is not working
38,612
Rheumatoid arthritis
23,596
Pain
21,295
Joint pain
20,151
Swollen joint
19,709
Tiredness
14,200
A medicine that should not be used was given
13,791
Cannot tolerate the medicine
12,991
Skin rash
12,957
Medicine used for a purpose not approved
11,743

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

Death-Related Reports

8,659

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
1 DRUG INEFFECTIVE 38,612
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
8 DRUG INTOLERANCE 12,991
9 RASH 12,957
10 OFF LABEL USE 11,743
11 ARTHROPATHY 11,573
12 ALOPECIA 10,533
13 SYNOVITIS 10,151
14 ABDOMINAL DISCOMFORT 10,008
15 TREATMENT FAILURE 9,693

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
OFF LABEL USE 1,914
FATIGUE 1,892
HYPERTENSION 1,886
GLOSSODYNIA 1,883

Reactions in Hospitalization Reports

DRUG INEFFECTIVE 6,476
RHEUMATOID ARTHRITIS 5,521
PAIN 4,980
ARTHRALGIA 4,253
ARTHROPATHY 4,191
FATIGUE 4,089
RASH 4,069
OFF LABEL USE 4,017
SYNOVITIS 3,911
JOINT SWELLING 3,897

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

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 fo...

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.

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.

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.

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.

What to do: This combination is not recommended. Talk to your doctor about using only one of these biologic treatments at a time.

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.

What to do: This combination is not recommended. Your doctor should avoid prescribing these two medications at the same time to prevent dangerous infections.

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 most commonly reported side effects of abatacept include Headache, Upper respiratory tract infection (like a cold), Runny nose, Nausea. Based on 189,045 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does abatacept interact with other medications?
Yes, abatacept has 5 known drug interactions. Notable interactions include adalimumab, certolizumab, etanercept. Always inform your doctor about all medications you are taking.
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.
Is abatacept safe during pregnancy?
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. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 189,045 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

All federal data sources used on this page