Adalimumab: uses, dosing, side effects & brands
Adalimumab is a tumor necrosis factor blocker sold in the U.S. under one brand, for juvenile arthritis, rheumatoid arthritis and ulcerative colitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Tumor Necrosis Factor Blocker
- Treats
- Juvenile Arthritis, Rheumatoid Arthritis and Ulcerative Colitis
- Available as
- Kit
- Sold as
- Humira
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How adalimumab is dosed
From the FDA label for Humira (application BLA125057). Other adalimumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer by subcutaneous injection ( 2 ) Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis ( 2.1 ): Adults: 40 mg every other week. Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week. Juvenile Idiopathic Arthritis or Pediatric Uveitis ( 2.2 ): Pediatric Weight 2 Years of Age and Older Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week Crohn's Disease ( 2.3 ): Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29. Pediatric Patients 6 Years of Age and Older : Pediatric Weight Recommended Dosage Days 1 and 15 Starting on Day 29 17 kg (37 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 15: 40 mg 20 mg every other week 40 kg (88 lbs) and greater Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg 40 mg every other week Ulcerative Colitis ( 2.4 ) : Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57). Pediatric Patients 5 Years of Age and Older :…
Adalimumab side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 ) ] Malignancies [see Warnings and Precautions ( 5.2 ) ] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 ) ] Hepatitis B Virus Reactivation [see Warnings and Precautions ( 5.4 ) ] Neurologic Reactions [see Warnings and Precautions ( 5.5 ) ] Hematological Reactions [see Warnings and Precautions ( 5.6 ) ] Heart Failure [see Warnings and Precautions ( 5.8 ) ] Autoimmunity [see Warnings and Precautions ( 5.9 ) ] Most common adverse reactions (>10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction with HUMIRA was injection site reactions. In placebo-controlled trials, 20% of subjects treated with HUMIRA developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of…
Who shouldn’t take adalimumab
None. None ( 4 )
Adalimumab drug interactions
Abatacept: Increased risk of serious infection. ( 5.1 , 5.11 , 7.2 ) Anakinra: Increased risk of serious infection. ( 5.1 , 5.7 , 7.2 ) Live vaccines: Avoid use with HUMIRA. ( 5.10, 7.3 ) 7.1 Methotrexate HUMIRA has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX). Although MTX reduced the apparent adalimumab clearance, the data do not suggest the need for dose adjustment of either HUMIRA or MTX [see Clinical Pharmacology ( 12.3 ) ] . 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 HUMIRA with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions ( 5.7 , 5.11 )] . A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of HUMIRA and other biologic products for the treatment of RA, PsA, AS, CD, UC, Ps, HS and UV. Concomitant administration of HUMIRA with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. 7.3 Live Vaccines Avoid the use of live vaccines with HUMIRA [see Warnings and Precautions ( 5.10 ) ] . 7.4 Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased concentrations of cytokines (e.g., TNFα, IL-6) during chronic inflammation. It is possible for a molecule that antagonizes cytokine activity, such as adalimumab, to influence the formation of CYP450 enzymes. Upon initiation or discontinuation of HUMIRA 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.
Every adalimumab product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Humira.
Adalimumab recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long adalimumab keeps
No adalimumab label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does adalimumab expire? The in-use limits and storage rules from its labelsAdalimumab and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for adalimumab: levels in milk, effects in breastfed infants, and the drugs it would consider insteadMaternal adalimumab injections produce low levels in breastmilk. Because adalimumab is a large protein molecule, it is likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Adalimumab was undetectable in the serum of some breastfed infants and adalimumab does not adversely affect the development of breastfed infants or increase the risk of infections. Waiting for at least 2 weeks postpartum to resume therapy suspended during pregnancy may minimize transfer to the infant. However, in infants of mothers who received adalimumab during late pregnancy, continued use while breastfeeding does not prolong adalimumab elimination by the infant. Numerous experts and professional guidelines have stated that adalimumab is a low risk to the nursing infant and acceptable to use during breastfeeding. Anti-TNF agents reduce the levels of tumor necrosis factor and IP-10 in the milk of mothers with inflammatory bowel disease in the early postpartum period. This reduction in TNF might lead to decreased milk production, so extra lactation support might be necessary in women taking adalimumab.
National Institute of Child Health and Human Development, record revised June 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about adalimumab
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 43,290 reports naming adalimumab, and the FDA flagged 94% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- rheumatoid arthritis5,494 reports
- fatigue5,290 reports
- arthralgia5,019 reports
- rash4,502 reports
- drug intolerance4,158 reports
- systemic lupus erythematosus4,007 reports
- nausea3,937 reports
- joint swelling3,929 reports
Read these as a signal, not a rate. A report does not mean adalimumab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is adalimumab?
Humira (Adalimumab) is a tumor necrosis factor blocker used to treat Juvenile Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease.
What kind of drug is adalimumab?
The FDA classifies adalimumab as a tumor necrosis factor blocker. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take adalimumab with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run adalimumab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does adalimumab come in?
Across the brands we track, adalimumab is currently marketed as kit, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic adalimumab?
We do not currently list a generic-labelled adalimumab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has adalimumab been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions adalimumab. The most recent: HADLIMA (adalimumab-bwwd) injection (Oct 10, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Adalimumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/adalimumab
- MLA
- “Adalimumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/adalimumab.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for adalimumab on DailyMed (NIH) ↗ — including its boxed warning in full.