Praluent

N/A

Manufactured by Regeneron Pharmaceuticals, Inc.

42,517 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Praluent

Praluent is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Regeneron Pharmaceuticals, Inc.. The most commonly reported adverse reactions for Praluent include MYALGIA, PRODUCT DOSE OMISSION, INJECTION SITE PAIN, MUSCLE SPASMS, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Praluent.

Top Adverse Reactions

MYALGIA1,667 reports
PRODUCT DOSE OMISSION1,364 reports
INJECTION SITE PAIN1,286 reports
MUSCLE SPASMS1,168 reports
ARTHRALGIA1,062 reports
FATIGUE1,023 reports
PAIN952 reports
PAIN IN EXTREMITY939 reports
PRODUCT DOSE OMISSION ISSUE911 reports
INJECTION SITE BRUISING848 reports
HEADACHE805 reports
INFLUENZA LIKE ILLNESS803 reports
DIARRHOEA801 reports
DEVICE ISSUE788 reports
COUGH708 reports
INJECTION SITE ERYTHEMA702 reports
DYSPNOEA697 reports
PRURITUS696 reports
INJECTION SITE HAEMORRHAGE685 reports
RASH673 reports
NAUSEA658 reports
DIZZINESS634 reports
MALAISE616 reports
NASOPHARYNGITIS584 reports
DRUG INEFFECTIVE579 reports
RHINORRHOEA533 reports
PRODUCT DELIVERY MECHANISM ISSUE526 reports
BACK PAIN522 reports
ASTHENIA491 reports
CONDITION AGGRAVATED479 reports
INJECTION SITE SWELLING475 reports
DEVICE USE ISSUE472 reports
PRODUCT USE ISSUE426 reports
FEELING ABNORMAL419 reports
PRODUCT PREPARATION ERROR418 reports
INJECTION SITE PRURITUS417 reports
MYOCARDIAL INFARCTION416 reports
PRODUCT STORAGE ERROR354 reports
LOW DENSITY LIPOPROTEIN INCREASED353 reports
DRUG DOSE OMISSION342 reports
GAIT DISTURBANCE332 reports
INCORRECT DOSE ADMINISTERED331 reports
INJURY ASSOCIATED WITH DEVICE331 reports
BLOOD CHOLESTEROL INCREASED322 reports
MUSCULAR WEAKNESS318 reports
INJECTION SITE MASS301 reports
CHEST PAIN300 reports
OROPHARYNGEAL PAIN295 reports
CEREBROVASCULAR ACCIDENT294 reports
DEATH294 reports
INFLUENZA292 reports
OFF LABEL USE292 reports
CHEST DISCOMFORT290 reports
ERYTHEMA289 reports
HYPERSENSITIVITY287 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION287 reports
UNEVALUABLE EVENT281 reports
FALL280 reports
MEMORY IMPAIRMENT279 reports
CARDIAC DISORDER270 reports
PRODUCT ADMINISTERED AT INAPPROPRIATE SITE268 reports
DRUG DOSE OMISSION BY DEVICE265 reports
PYREXIA264 reports
URTICARIA259 reports
INJECTION SITE RASH254 reports
INJECTION SITE REACTION254 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS253 reports
BLOOD GLUCOSE INCREASED246 reports
PERIPHERAL SWELLING241 reports
INSOMNIA240 reports
VOMITING229 reports
ABDOMINAL PAIN UPPER228 reports
ABDOMINAL DISCOMFORT227 reports
DYSPHONIA225 reports
WEIGHT DECREASED219 reports
UNDERDOSE218 reports
URINARY TRACT INFECTION217 reports
BLOOD PRESSURE INCREASED214 reports
WEIGHT INCREASED208 reports
CONTUSION203 reports
NASAL CONGESTION202 reports
ATRIAL FIBRILLATION199 reports
MUSCULOSKELETAL PAIN196 reports
HYPERTENSION195 reports
HOSPITALISATION190 reports
PNEUMONIA190 reports
SINUSITIS184 reports
HYPOAESTHESIA181 reports
CHILLS177 reports
PARAESTHESIA173 reports
ALOPECIA172 reports
CORONARY ARTERY DISEASE169 reports
ABDOMINAL PAIN165 reports
DECREASED APPETITE165 reports
MUSCULOSKELETAL STIFFNESS164 reports
COVID 19162 reports
THERAPEUTIC RESPONSE DECREASED162 reports
THERAPY INTERRUPTED162 reports
CONFUSIONAL STATE161 reports
WHEEZING159 reports

Report Outcomes

Out of 24,641 classified reports for Praluent:

  • Serious: 6,639 reports (26.9%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 18,002 reports (73.1%)
Serious 26.9%Non-Serious 73.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female12,675 (59.2%)
Male8,725 (40.7%)
Unknown19 (0.1%)

Reports by Age

Age 70597 reports
Age 68589 reports
Age 71543 reports
Age 69534 reports
Age 67531 reports
Age 75518 reports
Age 72513 reports
Age 74504 reports
Age 73495 reports
Age 65480 reports
Age 64468 reports
Age 76465 reports
Age 66462 reports
Age 63454 reports
Age 77452 reports
Age 62430 reports
Age 78387 reports
Age 60374 reports
Age 61372 reports
Age 59362 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Praluent?

This profile reflects 42,517 FDA FAERS reports that mention Praluent. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Praluent?

Frequently reported terms in FAERS include MYALGIA, PRODUCT DOSE OMISSION, INJECTION SITE PAIN, MUSCLE SPASMS, ARTHRALGIA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Praluent?

Labeling and FAERS entries often list Regeneron Pharmaceuticals, Inc. in connection with Praluent. Always verify the specific product and NDC with your pharmacist.

Other Drugs by Regeneron Pharmaceuticals, Inc.

Explore other medications manufactured by Regeneron Pharmaceuticals, Inc. and compare their safety profiles:

AFLIBERCEPT (85/100)ALIROCUMAB (45/100)

View all Regeneron Pharmaceuticals, Inc. drugs →

Drugs Also Linked to MYALGIA

The following drugs share commonly reported adverse reactions with Praluent:

ALECTINIB HYDROCHLORIDE (78/100)ALIROCUMAB (45/100)AMLODIPINE AND ATORVASTATIN (72/100)ATORVASTATIN CALCIUM (72/100)ATORVASTATIN CALCIUM, FILM COATED (72/100)BRYONIA ALBA ROOT (15/100)CAMPHOR (85/100)COLESEVELAM HYDROCHLORIDE (65/100)DENOSUMAB (78/100)ELACESTRANT (65/100)ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE (82/100)EVOLOCUMAB (35/100)

View all drugs reporting MYALGIA →

Explore More

Safety RankingsSearch All DrugsCompare DrugsRegeneron Pharmaceuticals, Inc. PortfolioMYALGIA in Other DrugsPRODUCT DOSE OMISSION in Other DrugsINJECTION SITE PAIN in Other Drugs
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.