What the label lists and what reports show
Adalimumab-afzb side effects
Adalimumab-afzb's FDA label: “Most common adverse reactions (>10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache, and rash.” FAERS holds 2,611 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 fatigue (260 reports).
- No generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the adalimumab-afzb FDA label on DailyMed (effective May 6, 2026, Pfizer Laboratories Div Pfizer Inc); 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 ABRILADA?ABRILADA can cause serious side effects, including: See " What is the most important information I should know about ABRILADA? " • Serious Infections. Your healthcare provider will examine you for TB and perform a test to see if you have TB. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with ABRILADA and during treatment with ABRILADA. Even if your TB test is negative your healthcare provider should carefully monitor you for TB infections while you are taking ABRILADA. People who had a negative TB skin test before receiving adalimumab products have developed active TB. […]
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective May 6, 2026 (SPL set 5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f), 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.
Table 1. Adverse Reactions Reported by ≥5% of Subjects Treated with Adalimumab During Placebo-Controlled Period of Pooled RA Studies (Studies RA-I, RA-II, RA-III, and RA-IV)
| Adverse Reaction (Preferred Term) | 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 Does not include injection site erythema, itching, hemorrhage,… | 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 Pfizer Inc. at 1-800-438-1985 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, Pfizer Laboratories Div Pfizer Inc, effective May 6, 2026 (SPL set 5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,611 reports list adalimumab-afzb among the medicines taken, each a report of something that happened, not proof the medicine caused it; 117 are coded as a death and 475 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 18 reactions below, 10 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-afzb: 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