Short answer: In the Repatha label's 52-week placebo-controlled trial, the most common side effects were common cold symptoms (10.5% vs 9.6% on placebo), upper respiratory infection (9.3% vs 6.3%), flu (7.5% vs 6.3%), back pain (6.2% vs 5.6%) and injection site reactions (5.7% vs 5.0%). There is no boxed warning; the one warning is allergic reactions, including angioedema, and latex in some needle covers.
What Repatha is approved for: Repatha is a PCSK9 inhibitor approved to lower the risk of major heart and blood vessel events (death from heart disease, heart attack, stroke, unstable angina needing a hospital stay, or procedures to restore blood flow) in adults at increased risk, and, alongside diet and exercise, to lower LDL cholesterol in adults with high cholesterol and in adults and children 10 and older with heterozygous or homozygous familial hypercholesterolemia (HeFH or HoFH) (section 1).
Source
REPATHA (evolocumab) injection, for subcutaneous use, prescribing information, Patient Information and Instructions for Use. Amgen. DailyMed, version published October 23, 2026. DailyMed setid cd61e902-166d-4aa6-9f3c-a18c1008d07e
No. The current Repatha label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Repatha.
| Adverse 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 | 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 |
599 adults with high cholesterol on Repatha 420 mg once a month. Side effects led to stopping in 2.2% on Repatha vs 1% on placebo. Injection site reactions include redness, pain and bruising.
| Adverse reaction | Placebo (N = 1,224) % | REPATHA 140 mg every 2 weeks and 420 mg once monthly combined (N = 2,052) % |
|---|---|---|
| Nasopharyngitis | 3.9 | 4.0 |
| Back pain | 2.2 | 2.3 |
| Upper respiratory tract infection | 2.0 | 2.1 |
| Arthralgia | 1.6 | 1.8 |
| Nausea | 1.2 | 1.8 |
| Fatigue | 1.0 | 1.6 |
| Muscle spasms | 1.2 | 1.3 |
| Urinary tract infection | 1.2 | 1.3 |
| Cough | 0.7 | 1.2 |
| Influenza | 1.1 | 1.2 |
| Contusion | 0.5 | 1.0 |
Seven 12-week trials: 993 adults on 140 mg every 2 weeks and 1,059 on 420 mg once a month.
Across eight pooled trials, injection site reactions were 3.2% on Repatha vs 3.0% on placebo, and allergic reactions 5.1% vs 4.7%, most often rash (1.0% vs 0.5%), eczema, redness and hives.
In the FOURIER heart outcomes trial (27,525 adults, median 24.8 months), common reactions were diabetes (8.8% vs 8.2% on placebo), common cold symptoms (7.8% vs 7.4%) and upper respiratory infection (5.1% vs 4.8%). New diabetes developed in 8.1% vs 7.7% of those without it at the start.
In the VESALIUS-CV trial (12,196 adults, median 53 months on Repatha), the safety profile was consistent with what was already known.
In 157 children aged 10 to 17 with HeFH over 24 weeks: common cold symptoms 12% vs 11% on placebo, headache 11% vs 2%, sore throat 7% vs 0%, flu 6% vs 4%, upper respiratory infection 6% vs 2%.
In 49 people with HoFH over 12 weeks: upper respiratory infection 9.1% vs 6.3%, flu 9.1% vs 0%, stomach flu 6.1% vs 0%, common cold symptoms 6.1% vs 0%.
Binding antibodies to evolocumab were found in 0.3% of adults (48 of 17,992), and none were neutralizing.
Reported after approval: angioedema (swelling under the skin) and flu-like illness.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Allergic reactions. Allergic reactions, including angioedema, have been reported. If signs of a serious reaction appear, Repatha is stopped, the reaction is treated and the person is watched until it clears.
Latex in some needle covers. Some SureClick autoinjectors and prefilled syringes have dry natural rubber (from latex) in the needle cover, which may cause allergic reactions in people sensitive to latex. Latex-free versions exist, and the prefilled pen is not made with natural rubber latex.
Who should not use it. People with a history of a serious allergic reaction to evolocumab or any ingredient in Repatha.
From the Patient Information that comes with Repatha:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.