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.
How to Take It
Praluent is given as an injection under the skin. Adults may inject Praluent every 2 weeks or every 4 weeks. Children inject Praluent every 4 weeks. Inject into your thigh, stomach area, or upper arm, and change the injection site each time.
This is a plain-language summary of alirocumab's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
There is not enough information about Praluent use during pregnancy to know if it is safe. If you are pregnant or plan to become pregnant, talk to your doctor before using Praluent.
This is a plain-language summary of alirocumab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose of Praluent, inject it as soon as you remember. Then, continue with your regular schedule.
This is a plain-language summary of alirocumab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Praluent in the refrigerator in its original carton to protect it from light. Do not freeze.
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
- Muscle pain
Muscle pain
1,655 reports
- Missed dose
Missed dose
1,364 reports
- Pain at injection site
Pain at injection site
1,278 reports
- Muscle spasms
Muscle spasms
1,162 reports
- Joint pain
Joint pain
1,053 reports
- Tiredness
Tiredness
1,018 reports
- Pain
Pain
945 reports
- Pain in arm or leg
Pain in arm or leg
935 reports
- Bruising at injection site
Bruising at injection site
838 reports
- Flu-like symptoms
Flu-like symptoms
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) 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?
Is alirocumab safe during pregnancy?
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
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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.
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colestipol
Colestid
Colestipol is a drug that helps lower cholesterol levels in your blood.
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: October 23, 2025
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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