Drug side effects
alirocumab Side Effects
The reactions most often reported to the FDA for alirocumab (also sold as Praluent), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 24,428
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2008 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of alirocumab come from 24,428 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 24,428 reports to the FDA Adverse Event Reporting System (FAERS) for alirocumab (Praluent): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
24,428
Reports Mentioning Death
492
2.0% of reports — not proof the medicine caused the death
Hospitalizations
2,529
10.4% of reports
Top Indication
Hyperlipidaemia
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 492 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| 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
Top reactions in 2,529 reports where hospitalization was an outcome.
| 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 |
Nearby, Related Medications
What the FAERS Data Reveals About alirocumab Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 24,428 voluntary reports linked to alirocumab and its brand equivalents (Praluent), spanning 2008 through 2025. Of those, 492 (2.0%) listed death as an outcome and 2,529 (10.4%) involved hospitalization. The most common indication reported alongside adverse events was Hyperlipidaemia.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 59% were female and 41% male; age distribution skews toward 65-74, with 5,189 reports in that bracket. The single most reported reaction is myalgia with 1,655 submissions, followed by product dose omission and injection site pain.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to alirocumab's 24,428.
Read our methodology - how this data is sourced, computed, and verified.