Adalimumab vs Omalizumab: side effects in FDA adverse event reports
At a glance
| Adalimumab | Omalizumab | |
|---|---|---|
| Drug class | – | Anti-IgE |
| Brand names | Humira | Xolair, Xolair Pfs |
| FAERS reports | 703,389 | 84,416 |
| Serious | 51% | 53% |
| Death outcome | 30,045 | 2,453 |
| Boxed warning | Yes WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead | Yes ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
Labeled signals distinctive to Adalimumab
- Synovitis — n=11,430, PRR 50.9 Labeled adverse reaction
- Duodenal ulcer perforation — n=4,928, PRR 60.4 Labeled (related wording)
- Muscle injury — n=3,785, PRR 24.9 Labeled (related wording)
- Injection site papule — n=3,181, PRR 70.5 Labeled (related wording)
- Rheumatoid nodule — n=1,249, PRR 23.7 Labeled (related wording)
- Injection site burning — n=562, PRR 73.3 Labeled (related wording)
- Granuloma skin — n=539, PRR 54.9 Labeled (related wording)
Labeled signals distinctive to Omalizumab
- Nasal oedema — n=375, PRR 65.4 Labeled (related wording)
- Smoke sensitivity — n=153, PRR 249.8 Labeled (related wording)
- Asthma-chronic obstructive pulmonary disease overlap syndrome — n=107, PRR 63.9 Labeled (related wording)
- Urinary tract discomfort — n=78, PRR 51.4 Labeled (related wording)
Common questions
Which has more reported side effects, Adalimumab or Omalizumab?
Adalimumab has 703,389 FAERS reports and Omalizumab 84,416. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (51% vs 53%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Adalimumab and Omalizumab share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Adalimumab or Omalizumab safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.