MID-VOLUME · SEX-BALANCED

alirocumab Side Effects

alirocumab (also sold as Praluent) sits MID-VOLUME #212 of 524 by FAERS report count. Lead signal: SEX-BALANCED - 59% of sex-coded reports are female (12,559 F / 8,648 M). Demographics and serious-outcome tables follow.

Data updated 2026-05-15

24,428
FAERS reports

FDA Adverse Event Reporting System extract for alirocumab. Stamp set WATCHLIST · DEATH-MARKED · HOSP-MID. How figures are compiled.

alirocumab reporting skew - 59% of sex-coded reports are female (12,559 F / 8,648 M). Volume band MID-VOLUME #212 of 524 by FAERS report count; caseload WATCHLIST.

Mid-book FAERS page for alirocumab (Praluent) (24,428 reports). Signature SEX-BALANCED. Dominant age band on file: 65-74. Educational reference only.

Counts from the openFDA FAERS extract (2008–2025). Stamps WATCHLIST · DEATH-MARKED · HOSP-MID · SEX-BALANCED.

MYALGIA leads 1,655 of 24,428 reports

MYALGIA
1,655
PRODUCT DOSE OMISSION
1,364
INJECTION SITE PAIN
1,278
MUSCLE SPASMS
1,162
ARTHRALGIA
1,053
FATIGUE
1,018
PAIN
945
PAIN IN EXTREMITY
935
INJECTION SITE BRUISING
838
INFLUENZA LIKE ILLNESS
802
DIARRHOEA
797
HEADACHE
797
DEVICE ISSUE
788
COUGH
702
INJECTION SITE ERYTHEMA
699
DYSPNOEA
696
PRURITUS
691
INJECTION SITE HAEMORRHAGE
679
RASH
667

Who reports · age peak 65-74 (SEX-BALANCED)

Sex coding · SEX-BALANCED

Female 12,559 (59%)
Male 8,648 (41%)
Unknown 19

Age peak 65-74 (5,189 reports)

0-17 9 (0%)
18-44 393 (3%)
45-64 4,610 (34%)
65-74 5,189 (38%)
75+ 3,388 (25%)

FAERS filings rising toward 2025

08
15
16
17
18
19
20
21
22
23
24
25

Reactions in Death Reports

Death appears on 492 reports (2.0% - MARKED). Reactions below co-occur in those rows only.

Reaction Reports
DEATH 285
MYOCARDIAL INFARCTION 30
CARDIAC ARREST 23
CARDIAC FAILURE 15
DYSPNOEA 14
CARDIAC FAILURE CONGESTIVE 11
CEREBROVASCULAR ACCIDENT 11
COUGH 11
HOSPITALISATION 11
PNEUMONIA 11
ASTHENIA 10
NEOPLASM MALIGNANT 10
CARDIAC DISORDER 9
CARDIOGENIC SHOCK 9
COMPLETED SUICIDE 9
FALL 9
RESPIRATORY ARREST 9
ACUTE MYOCARDIAL INFARCTION 8
COVID-19 8
FATIGUE 8

Reactions in Hospitalization Reports

Hospitalization mid-share (2,529, 10.4%). Co-reported reactions:

Reaction Reports
MYOCARDIAL INFARCTION 236
HOSPITALISATION 175
CEREBROVASCULAR ACCIDENT 169
DYSPNOEA 145
CHEST PAIN 131
FALL 120
PNEUMONIA 116
NAUSEA 108
DIZZINESS 105
DIARRHOEA 102
MALAISE 97
FATIGUE 94
MYALGIA 89
PAIN 87
ASTHENIA 79
CARDIAC DISORDER 75
PAIN IN EXTREMITY 72
HEADACHE 70
VOMITING 69
How to read alirocumab FAERS figures (WATCHLIST · DEATH-MARKED · HOSP-MID)

FAERS holds 24,428 voluntary reports linked to alirocumab (Praluent), 2008-2025. Death is listed on 492 (2.0%). Hospitalization appears on 2,529 (10.4%). Top co-reported indication: Hyperlipidaemia.

Mid-volume extract - treat DEATH-MARKED · HOSP-MID as signal-detection rates next to 59% of sex-coded reports are female (12,559 F / 8,648 M).

Read with alirocumab

Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-MID stamps.