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adalimumab

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Brand names: Humira

TNF-Alpha Inhibitor (Biologic) Rx

Idacio is a medicine that blocks a protein called TNF. It is used to treat several diseases, including arthritis and Crohn's disease.

Drug Pricing (NADAC)

Brand Price

$3361.23/unit

Generic Available

No

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

What it does

Idacio can help adults with rheumatoid arthritis by reducing joint pain and damage.

Common side effects

Infections (like colds or sinus infections), Injection site reactions (redness, itching, pain, or swelling), Headache

Key warnings

Idacio can increase your risk of serious infections that could lead to hospitalization or death.

How It Works

Idacio works by blocking a protein in your body called tumor necrosis factor (TNF). TNF can cause inflammation and damage in certain diseases. By blocking TNF, Idacio can reduce these symptoms.

How to Take It

Idacio is given as a shot under the skin (subcutaneous injection). The dose and how often you get it depends on your condition. For adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, the usual dose is 40 mg every other week. Some people with rheumatoid arthritis may need 40 mg every week or 80 mg every other week.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. Idacio can cross the placenta and may affect your baby's immune system. Talk to your doctor about vaccines for your baby if you took Idacio during pregnancy.

Missed Dose

If you miss a dose of Idacio, inject it as soon as you remember. Then, take your next dose at your regular scheduled time.

Storage

Store Idacio in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze and protect from light.

Side Effects (from patient reports)

Based on 415,869 FDA adverse event reports.

The medicine is not working
90,713
Pain
49,062
Joint pain
48,041
Pain at the injection site
47,251
Tiredness
39,113
Rheumatoid arthritis
35,571
Headache
28,330
Feeling sick to your stomach
27,103
Diarrhea
25,414
Rash
25,271

FDA Adverse Event Report Analysis

Detailed analysis of 695,825 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

695,825

Death-Related Reports

28,962

Hospitalization Reports

146,638

Top Indication

Rheumatoid Arthritis

Gender Distribution

Female 446,643 (68%)
Male 209,782 (32%)

Age Distribution

0–17 13,009
18–44 108,536
45–64 160,251
65–74 56,676
75+ 24,220

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DRUG INEFFECTIVE 90,715
2 PAIN 49,062
3 ARTHRALGIA 48,039
4 INJECTION SITE PAIN 47,251
5 FATIGUE 39,111
6 RHEUMATOID ARTHRITIS 35,573
7 HEADACHE 28,330
8 NAUSEA 27,102
9 DIARRHOEA 25,413
10 RASH 25,271
11 PSORIASIS 24,707
12 PAIN IN EXTREMITY 24,313
13 JOINT SWELLING 23,282
14 INCORRECT DOSE ADMINISTERED 22,332
15 MALAISE 21,339

Reactions in Death Reports

DEATH 11,907
PNEUMONIA 2,626
OFF LABEL USE 2,598
FATIGUE 2,586
RHEUMATOID ARTHRITIS 2,547
GENERAL PHYSICAL HEALTH DETERIORATION 2,440
HYPERTENSION 2,402
PAIN 2,389
ARTHRALGIA 2,303
JOINT SWELLING 2,292

Reactions in Hospitalization Reports

DRUG INEFFECTIVE 14,728
PAIN 12,371
ARTHRALGIA 11,485
DIARRHOEA 9,534
CROHN^S DISEASE 9,448
FATIGUE 9,183
PNEUMONIA 8,880
PYREXIA 8,750
NAUSEA 8,539
VOMITING 8,458

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

Serious Warnings

Idacio can increase your risk of serious infections that could lead to hospitalization or death. Tell your doctor if you have any infections before starting Idacio. Idacio may also increase your risk of certain cancers, including lymphoma. Children and teens taking TNF blockers like Idacio have developed rare, aggressive cancers.

Known Drug Interactions

moderate abatacept

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.

Upon initiation or discontinuation of IDACIO 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: Adalimumab can change how your body processes other drugs like warfarin, which could make the blood thinner more or less effective.

What to do: Your doctor should closely monitor your blood clotting levels and may need to adjust your warfarin dose when starting or stopping this medicine.

( 5.10 , 7.3 ) 7.1 Methotrexate Adalimumab has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX).

Mechanism: These two drugs are often used together to treat joint pain, and methotrexate can help the body accept the other medicine better.

What to do: Your doctor will monitor your condition while you take both of these medications together.

Upon initiation or discontinuation of IDACIO 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: Adalimumab can change how your liver breaks down other medicines, which can cause the amount of cyclosporine in your blood to change.

What to do: Your doctor should check your blood levels of cyclosporine and may need to adjust your dose.

Upon initiation or discontinuation of IDACIO 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 affect the way your body processes theophylline, which might lead to levels that are too high or too low.

What to do: Your doctor should monitor your theophylline blood levels and adjust your dose if needed.

Common Questions

What if I have an infection?
Do not start Idacio if you have an active infection. Tell your doctor right away if you get any signs of infection during treatment.
Can Idacio cause cancer?
Idacio may increase your risk of certain cancers, including lymphoma. Talk to your doctor about this risk.
Can I take Idacio with other medicines?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Can I get vaccines while taking Idacio?
Avoid live vaccines while taking Idacio. Talk to your doctor before getting any vaccines.
How will I know if Idacio is working?
Your doctor will monitor your condition to see if Idacio is helping. You may notice a decrease in your symptoms.
What should I do if I have side effects?
Tell your doctor about any side effects you have while taking Idacio. They may be able to help you manage them.
How is Idacio given?
Idacio is given as a shot under the skin (subcutaneous injection).
How often will I get Idacio?
How often you get Idacio depends on your condition. Your doctor will tell you how often to take it.
What does Idacio look like?
The solution of IDACIO is clear and colorless to pale yellow.
What should I do before each injection?
Clean the injection site with an alcohol prep.
What are the common side effects of adalimumab?
The most commonly reported side effects of adalimumab include Infections (like colds or sinus infections), Injection site reactions (redness, itching, pain, or swelling), Headache, Rash. Based on 415,869 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does adalimumab interact with other medications?
Yes, adalimumab has 5 known drug interactions. Notable interactions include abatacept, warfarin, methotrexate. Always inform your doctor about all medications you are taking.
What drug class is adalimumab?
adalimumab belongs to the TNF-Alpha Inhibitor (Biologic) drug class. It requires a prescription (Rx). Idacio can help adults with rheumatoid arthritis by reducing joint pain and damage.
Is adalimumab safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. Idacio can cross the placenta and may affect your baby's immune system. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has adalimumab been recalled?
There is 1 recall associated with adalimumab products. Lack of Assurance of Sterility. Check the recalls section below for full details and affected products.

Active Recalls

Class II October 10, 2025

Lack of Assurance of Sterility.

Samsung Bioepis Co., Ltd.

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What the FDA Data Shows for adalimumab

The FDA label for adalimumab (sold under brand names such as Humira) classifies it as a prescription-only medication in the TNF-Alpha Inhibitor (Biologic) class. Idacio can help adults with rheumatoid arthritis by reducing joint pain and damage. Official labeling lists 4 commonly reported side effects, including Infections (like colds or sinus infections), Injection site reactions (redness, itching, pain, or swelling), Headache.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 415,869 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 (currently 1 recall record on file), 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: October 15, 2024

All federal data sources used on this page