Evolocumab vs Ezetimibe: side effects in FDA adverse event reports
At a glance
| Evolocumab | Ezetimibe | |
|---|---|---|
| Drug class | PCSK9 Inhibitor | Dietary Cholesterol Absorption Inhibitor |
| Brand names | Repatha | – |
| FAERS reports | 161,209 | 74,507 |
| Serious | 17% | 65% |
| Death outcome | 2,035 | 4,305 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Evolocumab | Ezetimibe | Label screen (A / B) |
|---|---|---|---|
| Type iia hyperlipidaemia | 69 · PRR 56.7 | 65 · PRR 113.1 | Not in label — unassessed / Likely indication confounding |
| Vascular stent stenosis | 44 · PRR 15.3 | 46 · PRR 34.9 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Evolocumab
- Injection site bruising — n=4,800, PRR 8.4 Labeled (related wording)
- Injection site indentation — n=300, PRR 22.3 Labeled (related wording)
- Rubber sensitivity — n=156, PRR 14.7 Labeled (related wording)
Labeled signals distinctive to Ezetimibe
- Myopathy — n=431, PRR 14.7 Labeled adverse reaction
- Dyslipidaemia — n=221, PRR 12.7 Labeled adverse reaction
Common questions
Which has more reported side effects, Evolocumab or Ezetimibe?
Evolocumab has 161,209 FAERS reports and Ezetimibe 74,507. 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 (17% vs 65%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Evolocumab and Ezetimibe share?
Both drugs carry disproportionality signals for type iia hyperlipidaemia, vascular stent stenosis. Shared signals often reflect a shared drug class or the condition both are used for.
Is Evolocumab or Ezetimibe 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.