What the label lists and what reports show
Adalimumab side effects
Adalimumab's FDA label: “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 Sandoz Inc.” FAERS holds 712,308 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (50,418 reports).
- No generic listed
- Boxed warning
Check it at the source: the adalimumab FDA label on DailyMed (effective October 21, 2025); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Adalimumab-adaz?Adalimumab-adaz can cause serious side effects, including: See “ What is the most important information I should know about Adalimumab-adaz? ” • Serious Infections. Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Adalimumab-adaz and during treatment with Adalimumab-adaz. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking Adalimumab-adaz. People who had a negative TB skin test before receiving adalimumab products have developed active TB. […]
Source: FDA drug label, Sandoz Inc, effective October 21, 2025 (SPL set 3468792f-63ef-4916-8ed1-8214f327d9dd), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost 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 Sandoz Inc.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Adalimumab 40 mg subcutaneous Every Other Week (N=705) | Placebo (N=690) |
|---|---|---|
| Upper respiratory infection | 17 % | 13 % |
| Sinusitis | 11 % | 9 % |
| Flu syndrome | 7 % | 6 % |
| Nausea | 9 % | 8 % |
| Abdominal pain | 7 % | 4 % |
| Laboratory test abnormal | 8 % | 7 % |
| Hypercholesterolemia | 6 % | 4 % |
| Hyperlipidemia | 7 % | 5 % |
| Hematuria | 5 % | 4 % |
| Alkaline phosphatase increased | 5 % | 3 % |
| Headache | 12 % | 8 % |
| Rash | 12 % | 6 % |
| Accidental injury | 10 % | 8 % |
| Injection site reaction | 8 % | 1 % |
| Back pain | 6 % | 4 % |
| Urinary tract infection | 8 % | 5 % |
| Hypertension | 5 % | 3 % |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 Sandoz Inc. at 1-800-525-8747 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 adalimumab was injection site reactions. …
Source: FDA drug label, Sandoz Inc, effective October 21, 2025 (SPL set 3468792f-63ef-4916-8ed1-8214f327d9dd), via openFDA; the full label on DailyMed
What do FAERS reports show?
712,308 reports list adalimumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 30,985 are coded as a death and 151,145 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Adalimumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions