Generic name
Alirocumab: adverse event reports filed with FDA
934 reports list it as a suspect or interacting product, 2015–2026. Class: PCSK9 inhibitor.
- 934
- reports as suspect product
- 0% of all reports · about 85 a year
- 39
- reports, 12 months to June 2026
- 31 in the 12 months before
- 51.3%
- marked serious by the reporter
- 17% across the class
- 2.5%
- record death among outcomes, as reported
- 23 reports · not verified by FDA
934 adverse event reports received by FDA list alirocumab, a generic name as a suspect or interacting product, from July 2015 to June 2026. A further 223 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 39 reports listed it, up 26% from 31 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 85 reports a year and 0% of the 20,646,523 reports in the database, and 0.5% of the reports for the PCSK9 inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are myalgia (11.8%), muscle spasms (9.4%) and product dose omission (9.2%). A report can list several reactions, so shares add to more than 100%; 336 different terms appear across these reports. Myalgia is recorded in 11.8% of these reports, a larger share than in the median PCSK9 inhibitor drug (5.6%).
51.3% of the reports are marked serious by the reporter (17% across the class); 2.5% record death among the outcomes and 18.7% record hospitalisation, as reported. 61.5% of the reports came from consumers, and the largest patient age group is 65 to 74 (31.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Alirocumab reports recording the termmedian drug in pcsk9 inhibitor
- Myalgiamuscle pain11.8%110
- Muscle spasmsmuscle cramps9.4%88
- Product dose omissiona dose was missed9.2%86
- Coughcough7.8%73
- Nasopharyngitisa cold7.4%69
- Dyspnoeashortness of breath7.1%66
- Injection site painpain where the injection was given6.4%60
- Malaisegeneral feeling of being unwell5.7%53
- Arthralgiajoint pain5.5%51
- Pain in extremitypain in an arm or leg5.5%51
- Diarrhoealoose or frequent stools5.4%50
- Condition aggravatedthe condition being treated got worse5.1%48
- Nauseafeeling sick5.1%48
- Painpain, site not specified5.1%48
- Device issuea problem with the device4.4%41
- Cardiac disorder4.3%40
- Coronary artery disease4.3%40
- Injection site bruisingbruising where the injection was given4.3%40
- Dysphoniaa hoarse voice4.2%39
- Fatiguetiredness4.2%39
- Chest discomfortchest discomfort4.1%38
- Headachehead pain4.1%38
- Influenza like illnessflu-like symptoms4%37
- Injection site erythemaredness where the injection was given3.9%36
- Rhinorrhoeaa runny nose3.7%35
- Dyspnoea exertional3.6%34
- Injection site swellingswelling where the injection was given3.6%34
- Atrial fibrillationan irregular heart rhythm3.5%33
- Brain natriuretic peptide increased3.4%32
- Dizzinesslight-headedness or unsteadiness3.4%32
Top 30 of 336 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the pcsk9 inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 180,025 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 66.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Type iia hyperlipidaemia | 128 | 13.7% |
| Hypercholesterolaemia | 115 | 12.3% |
| Blood cholesterol increased | 108 | 11.6% |
| Hyperlipidaemia | 104 | 11.1% |
| Blood cholesterol | 58 | 6.2% |
| Blood cholesterol abnormal | 22 | 2.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 934 reports.
In context
| Measure | Alirocumab | PCSK9 inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 934 | 180,025 | 20,646,523 |
| Share of that pool | — | 0.5% | 0% |
| Reports, latest 12 months | 39 | — | 1,332,454 |
| Marked serious | 51.3% | 17% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 25 | 13 | 91 |
| Hospitalisation recorded, per 1,000 reports | 187 | 55 | 213 |
| Consumer-filed share | 61.5% | 53.7% | 45.8% |
| Top term, share of reports | Myalgia 11.8% | median 5.6% | 0.8% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the pcsk9 inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Repatha | brand | 155,654 | 8,546 | 15.2% |
| Praluent | brand | 22,476 | 1,068 | 24.9% |
| Evolocumab | generic | 961 | 121 | 91.5% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Alirocumab reports
How many adverse event reports has FDA received for Alirocumab?
934 reports list Alirocumab as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 39 of them arrived in the latest 12 months. Another 223 list it only as a concomitant medication.
What reactions are recorded in Alirocumab reports?
myalgia (11.8%), muscle spasms (9.4%), product dose omission (9.2%), cough (7.8%) and nasopharyngitis (7.4%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Alirocumab was responsible.
How serious are the reports?
51.3% are marked serious by the reporter. Among the outcomes recorded, 2.5% of reports include death and 18.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (61.5%), other health professional (19%) and physician (15.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Alirocumab rising?
39 reports in the 12 months to June 2026, up 26% from 31 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Alirocumab was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Alirocumab?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Alirocumab as a suspect or interacting product; reports listing it only as a concomitant medication (223) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.