What the label lists and what reports show
Evolocumab side effects
Evolocumab's FDA label: “The most common adverse reaction that led to REPATHA treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for REPATHA and placebo, respectively).” FAERS holds 161,222 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is device difficult to use (32,925 reports).
- No generic listed
Check it at the source: the evolocumab FDA label on DailyMed (effective August 19, 2026, Amgen USA Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of REPATHA?REPATHA can cause serious side effects including: Serious Allergic Reactions. Some people taking REPATHA have had serious allergic reactions. Stop taking REPATHA and call your healthcare provider or seek emergency medical help right away if you or your child have any of these symptoms: trouble breathing or swallowing raised bumps (hives) rash, or itching swelling of the face, lips, tongue, throat or arms The most common side effects of REPATHA include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, high blood sugar levels (diabetes) and redness, pain, or bruising at the injection site. Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away. These are not all the possible side effects of REPATHA. Ask your healthcare provider or pharmacist for more information. […]
Source: FDA drug label, Amgen USA Inc., effective August 19, 2026 (SPL set cd61e902-166d-4aa6-9f3c-a18c1008d07e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reaction that led to REPATHA treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for REPATHA and placebo, respectively).
Table 1. Adverse Reactions Occurring in ≥ 3% of REPATHA-treated Patients and More Frequently than with Placebo in a 52-Week Trial
| Reaction | Placebo (N = 302) % | REPATHA (N = 599) % |
|---|---|---|
| Nasopharyngitis | 9.6 | 10.5 |
| Upper respiratory tract infection | 6.3 | 9.3 |
| Influenza | 6.3 | 7.5 |
| Back pain | 5.6 | 6.2 |
| Injection site reactions includes erythema, pain, bruising | 5.0 | 5.7 |
| Cough | 3.6 | 4.5 |
| Urinary tract infection | 3.6 | 4.5 |
| Sinusitis | 3.0 | 4.2 |
| Headache | 3.6 | 4.0 |
| Myalgia | 3.0 | 4.0 |
| Dizziness | 2.6 | 3.7 |
| Musculoskeletal pain | 3.0 | 3.3 |
| Hypertension | 2.3 | 3.2 |
| Diarrhea | 2.6 | 3.0 |
| Gastroenteritis | 2.0 | 3.0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are also discussed in other sections of the label: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Common (> 5% of patients treated with REPATHA and more frequently than placebo) adverse reactions in adults with: Primary hypercholesterolemia: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. ( 6 ) Established CV Disease: diabetes mellitus, nasopharyngitis and upper respiratory tract infection. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions in Adults with Primary Hypercholesterolemia The data described below reflect exposure to REPATHA in 8 placebo-controlled trials that included 2651 patients treated with REPATHA, including 557 exposed for 6 months and 515 exposed for 1 year (median treatment duration of 12 weeks). The mean age of the population was 57 years, 49% of the population were women, 85% White, 6% Black, 8% Asian, and 2% other races.
Source: FDA drug label, Amgen USA Inc., effective August 19, 2026 (SPL set cd61e902-166d-4aa6-9f3c-a18c1008d07e), via openFDA; the full label on DailyMed
What do FAERS reports show?
161,222 reports list evolocumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,035 are coded as a death and 8,504 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Evolocumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions