Prescription medication · PCSK9 Inhibitor
alirocumab
Also sold as Praluent. Praluent is used to lower LDL cholesterol (bad cholesterol).
Data updated 2026-05-15
- 24,428
- FDA reportsModerately reported
- $243.94
- Brand price (NADAC)
alirocumab (Praluent) is a prescription PCSK9 Inhibitor. Praluent is used to lower LDL cholesterol (bad cholesterol).
Praluent is a medicine that can lower cholesterol. It can also lower the risk of heart problems like heart attack or stroke in some adults.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$243.94/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Praluent is used to lower LDL cholesterol (bad cholesterol).
Common side effects
Injection site reactions (redness, itching, swelling, pain), Flu, Muscle pain
Key warnings
Serious allergic reactions have happened with Praluent, sometimes requiring hospitalization.
The sections below are summarized in plain English from alirocumab's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Praluent is a PCSK9 inhibitor. It works by blocking a protein in your body called PCSK9. Blocking this protein helps your body remove LDL cholesterol from your blood.
Side Effects (from patient reports)
Based on 24,428 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for alirocumab, by number of reports
- Myalgia
Myalgia
1,655 reports
- Product Dose Omission
Product Dose Omission
1,364 reports
- Injection Site Pain
Injection Site Pain
1,278 reports
- Muscle Spasms
Muscle Spasms
1,162 reports
- Arthralgia
Arthralgia
1,053 reports
- Fatigue
Fatigue
1,018 reports
- Pain
Pain
945 reports
- Pain In Extremity
Pain In Extremity
935 reports
- Injection Site Bruising
Injection Site Bruising
838 reports
- Influenza Like Illness
Influenza Like Illness
802 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for alirocumab each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where alirocumab sits
alirocumab has more FDA adverse-event reports than 60% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is alirocumab; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 24,428 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2008–2025.
Total Reports
24,428
Reports Mentioning Death
492
2.0% of reports — not proof of cause
Hospitalization Reports
2,529
Top Indication
Hyperlipidaemia
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | MYALGIA | 1,655 |
| 2 | PRODUCT DOSE OMISSION | 1,364 |
| 3 | INJECTION SITE PAIN | 1,278 |
| 4 | MUSCLE SPASMS | 1,162 |
| 5 | ARTHRALGIA | 1,053 |
| 6 | FATIGUE | 1,018 |
| 7 | PAIN | 945 |
| 8 | PAIN IN EXTREMITY | 935 |
| 10 | INJECTION SITE BRUISING | 838 |
| 11 | INFLUENZA LIKE ILLNESS | 802 |
| 12 | DIARRHOEA | 797 |
| 13 | HEADACHE | 797 |
| 14 | DEVICE ISSUE | 788 |
| 15 | COUGH | 702 |
| 16 | INJECTION SITE ERYTHEMA | 699 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Serious allergic reactions have happened with Praluent, sometimes requiring hospitalization. If you have signs of a serious allergic reaction, stop using Praluent and get medical help right away.
Common Questions
How often will I inject Praluent?
Can children take Praluent?
What should I do if I have an allergic reaction?
How long does Praluent take to work?
Where should I inject Praluent?
Can I travel with Praluent?
What if my cholesterol doesn't go down enough?
Does Praluent interact with other medications?
Can I stop taking Praluent if my cholesterol is better?
How should I dispose of used Praluent pens?
What are the common side effects of alirocumab?
What drug class is alirocumab?
What pregnancy or breastfeeding source fields are listed for alirocumab?
Related Medications in PCSK9 Inhibitor
Other drugs grouped near alirocumab - same-class peers and common alternatives.
atorvastatin
Lipitor
Atorvastatin is a drug that lowers cholesterol and reduces the risk of heart problems and stroke.
Compare with alirocumab →
bempedoic acid
Nexletol
Compare with alirocumab →
bempedoic acid/ezetimibe
Nexlizet
Nexlizet is a combination medicine that helps lower cholesterol.
Compare with alirocumab →
cholestyramine
Questran
Cholestyramine is a medicine that helps lower high cholesterol levels in your blood.
Compare with alirocumab →
colestipol
Colestid
Colestipol is a drug that helps lower cholesterol levels in your blood.
Compare with alirocumab →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for alirocumab: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 24,428.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 2.01%.
- isotretinoin Δ 0.17 pts · 47,513 reports · Systemic Retinoid 1.85%death share
- dulaglutide Δ 0.17 pts · 85,635 reports · GLP-1 Receptor Agonist 1.85%death share
- eluxadoline Δ 0.18 pts · 2,870 reports · Mu-Opioid Receptor Agonist (IBS-D) 2.20%death share
- lifitegrast Δ 0.22 pts · 15,783 reports · LFA-1 Antagonist (Ophthalmic) 1.79%death share
Medication Guides
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FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for alirocumab
The FDA label for alirocumab (sold under brand names such as Praluent) classifies it as a prescription-only medication in the PCSK9 Inhibitor class. Praluent is used to lower LDL cholesterol (bad cholesterol). Official labeling lists 4 commonly reported side effects, including Injection site reactions (redness, itching, swelling, pain), Flu, Muscle pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 24,428 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: October 23, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages