Tocilizumab vs Anakinra: side effects in FDA adverse event reports
At a glance
| Tocilizumab | Anakinra | |
|---|---|---|
| Drug class | Interleukin-6 Receptor Antagonist | Interleukin-1 Receptor Antagonist |
| Brand names | Actemra, Actemra Actpen | Kineret |
| FAERS reports | 113,340 | 16,488 |
| Serious | 77% | 69% |
| Death outcome | 12,342 | 1,515 |
| Boxed warning | Yes RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see | No |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
Labeled signals distinctive to Tocilizumab
- Duodenal ulcer perforation — n=5,011, PRR 406.8 Labeled — boxed warning
- Sleep disorder due to general medical condition, insomnia type — n=3,133, PRR 176.4 Labeled (related wording)
- Hepatic enzyme — n=85, PRR 291.0 Labeled (related wording)
Labeled signals distinctive to Anakinra
- Autoinflammatory disease — n=54, PRR 451.3 Labeled (related wording)
Common questions
Which has more reported side effects, Tocilizumab or Anakinra?
Tocilizumab has 113,340 FAERS reports and Anakinra 16,488. 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 (77% vs 69%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tocilizumab and Anakinra share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Tocilizumab or Anakinra 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.