adalimumab
Brand names: Humira
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.
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
Age Distribution
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
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
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
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?
Can Idacio cause cancer?
Can I take Idacio with other medicines?
Can I get vaccines while taking Idacio?
How will I know if Idacio is working?
What should I do if I have side effects?
How is Idacio given?
How often will I get Idacio?
What does Idacio look like?
What should I do before each injection?
What are the common side effects of adalimumab?
Does adalimumab interact with other medications?
What drug class is adalimumab?
Is adalimumab safe during pregnancy?
Has adalimumab been recalled?
Active Recalls
Lack of Assurance of Sterility.
Samsung Bioepis Co., Ltd.
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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 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
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