HIGH-VOLUME · DEVICE DIFFICULT TO USE
evolocumab Side Effects
evolocumab (also sold as Repatha) is HIGH-VOLUME in this FAERS book #43 of 524 by FAERS report count. Signature opener: DEVICE DIFFICULT TO USE - DEVICE DIFFICULT TO USE leads at 32,421 reports (20.9% of the book).
Data updated 2026-05-15
- 155,068
- FAERS reports
FAERS voluntary reports, 2008 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
Among 155,068 FAERS reports for evolocumab, DEVICE DIFFICULT TO USE is the most-reported reaction (32,421). Volume band HIGH-VOLUME #43 of 524 by FAERS report count.
High-report extract for evolocumab (Repatha): 155,068 FAERS rows (2008-2025). Top named reactions: DEVICE DIFFICULT TO USE, DRUG DOSE OMISSION BY DEVICE, ACCIDENTAL EXPOSURE TO PRODUCT. Outcome stamps DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2008–2025). Stamps MEGA-CASE · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
DEVICE DIFFICULT TO USE leads 32,421 of 155,068 reports
Who reports · age peak 65-74 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 65-74 (39,454 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 1,849 reports (1.2% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 1,305 |
| MYOCARDIAL INFARCTION | 95 |
| DISEASE PROGRESSION | 59 |
| TYPE IIA HYPERLIPIDAEMIA | 55 |
| CEREBROVASCULAR ACCIDENT | 43 |
| CARDIAC ARREST | 40 |
| CARDIOVASCULAR DISORDER | 31 |
| CARDIAC DISORDER | 27 |
| NAUSEA | 25 |
| CARDIAC FAILURE | 22 |
| PNEUMONIA | 21 |
| CARDIO-RESPIRATORY ARREST | 20 |
| COVID-19 | 20 |
| NEOPLASM MALIGNANT | 20 |
| UNEVALUABLE EVENT | 20 |
| HYPOTENSION | 19 |
| HOSPITALISATION | 18 |
| SUDDEN DEATH | 18 |
| BACK PAIN | 17 |
Reactions in Hospitalization Reports
Hospitalization is lighter here (7,680). Reactions in that subset:
| Reaction | Reports |
|---|---|
| HOSPITALISATION | 637 |
| DEVICE DIFFICULT TO USE | 583 |
| MYOCARDIAL INFARCTION | 473 |
| UNEVALUABLE EVENT | 408 |
| DYSPNOEA | 382 |
| DRUG DOSE OMISSION BY DEVICE | 356 |
| CEREBROVASCULAR ACCIDENT | 352 |
| PNEUMONIA | 346 |
| FALL | 293 |
| NAUSEA | 262 |
| DIZZINESS | 258 |
| CHEST PAIN | 249 |
| FATIGUE | 241 |
| HEADACHE | 231 |
| BACK PAIN | 230 |
| DIARRHOEA | 217 |
| ARTHRALGIA | 212 |
| ASTHENIA | 211 |
| MALAISE | 202 |
How to read evolocumab FAERS figures (MEGA-CASE · DEATH-MARKED · HOSP-LIGHT)
FAERS holds 155,068 voluntary reports linked to evolocumab (Repatha), 2008-2025. Death is listed on 1,849 (1.2%). Hospitalization appears on 7,680 (5.0%). Top co-reported indication: Product Used For Unknown Indication.
MEGA-CASE books overweight common drugs and loud reporting cultures; DEVICE DIFFICULT TO USE is the page opener, not a per-patient risk.
Read with evolocumab
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-LIGHT stamps.
ABS(total_reports) peer at 155,147 FAERS cases (Δ 79 heavier vs evolocumab); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 157,236 FAERS cases (Δ 2,168 heavier vs evolocumab); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 150,998 FAERS cases (Δ 4,070 lighter vs evolocumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 165,585 FAERS cases (Δ 10,517 heavier vs evolocumab); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 60.9 pp vs evolocumab's DEATH-MARKED): CASELOAD · HOSP-MID.
evolocumab sits in MEGA-CASE; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.