Injection Site Reactions on Antibody Shots: Label Rates
[Answers · Injecting]

How common are injection site reactions on antibody shots?

From FDA labels, public health agencies and published studies · Reviewed

Short answer: Usually a few percent more than placebo. The labels report injection site reactions in 7.2% on Praluent vs 5.1%, 3.2% on Repatha vs 3.0%, and 4.9% on Evenity vs 2.8% on its comparison group. Leqvio, which is not an antibody, reports 8% vs 2%. Redness, pain, itching, swelling and bruising are the usual signs, and few people stopped because of them.

Rates from the labels

Praluent (alirocumab), Repatha (evolocumab), Evenity (romosozumab) and Prolia (denosumab) are monoclonal antibodies given under the skin. Leqvio (inclisiran) is a small interfering RNA, included here because it is often compared with the PCSK9 antibodies.

Injection site reactions (labels, section 6.1)
Medicine and trialsMedicineComparisonStopped because of it
Praluent 75 or 150 mg every 2 weeks, pooled placebo trials7.2%5.1% placebo0.2% vs 0.4%
Praluent 300 mg every 4 weeks (48-week trial)16.6%7.9% placebo (9.6% on 75 mg)0.7% vs 0%
Praluent, ODYSSEY OUTCOMES3.8%2.1% placebo0.3% vs under 0.1%
Repatha, 8 pooled trials3.2%3.0% placebo0.1% vs 0%
Evenity, 2 trials in women with osteoporosis4.9%2.8% control0.1% vs under 0.1%
Leqvio, 3 trials (not an antibody)8%2% placebo0.2% vs 0%

The Praluent label adds that people on Praluent had more reactions, more symptoms with them, and reactions that lasted longer on average than on placebo. The 300 mg dose is given as two 150 mg injections at two different sites, which may be part of why its rate is higher. Prolia lists injection site reactions among reports after approval, without a rate.

What the reactions look like

The labels name the same few signs: redness (erythema), pain or tenderness, itching, swelling and bruising. On Evenity, the most common were pain (1.7% vs 1.3%) and redness (1.4% vs 0.3%). On Repatha, redness, pain and bruising.

A local reaction is different from an allergic reaction. The Praluent and Repatha labels warn about allergic reactions, including swelling under the skin (angioedema), and the Evenity label warns about hives, rash and angioedema. Swelling of the face, lips, tongue or throat, trouble breathing, or a widespread rash is the kind of reaction the labels say to stop for and get treated right away.

Site rules in the labels

The Praluent and Repatha labels say to inject into the thigh, abdomen or upper arm, into skin that is not tender, bruised, red or hard, and to rotate sites at each dose. Repatha adds avoiding scars and stretch marks; Evenity gives the same skin rules and says to choose a different spot each time. The Leqvio instructions say not to inject into areas of active skin disease or injury such as sunburn, rashes, inflammation or infection.

Several of these labels also ask for a warm-up out of the fridge before injecting; see should injections warm to room temperature.

Keeping track

A reaction that keeps coming back, grows from one dose to the next or does not fade is worth showing to the prescriber. Dose Track logs the site of every injection and can attach a side-effect note to the dose, so it is clear which spots reacted and when.

Read more on Dose Track: Injection site reaction · Praluent side effects · Repatha side effects · Evenity side effects · Injection site rotation guide

General education drawn from labels, public health agencies and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your medicine are the final word. Questions for other users? Ask in the Dose Track community.

Frequently asked questions

Is redness after a Praluent or Repatha shot normal?+
Redness, pain, itching, swelling and bruising are the injection site reactions named in both labels. They were reported in 7.2% on Praluent and 3.2% on Repatha.
Why does the Praluent 300 mg dose cause more site reactions?+
The label reports 16.6% on 300 mg every 4 weeks vs 9.6% on 75 mg every 2 weeks. The 300 mg dose is given as two injections at two sites.
How is a site reaction different from an allergic reaction?+
A site reaction stays at the injection spot. The labels warn about allergic reactions such as swelling of the face, lips or throat, or a widespread rash, which need treatment right away.
Does Leqvio cause injection site reactions?+
Yes. The Leqvio label reports them in 8% vs 2% on placebo, including pain, redness and rash.