The site figure and its neighbours
Section 6.1 of the US label reports injection site reactions in text rather than in a table, because at 1.4% they fall below the adult table’s 2% cut-off. [1] The table below sets that figure next to the EU and Canadian versions and other skin findings, so the differences are clear.
| Finding, source and group | Placebo | Wegovy® |
|---|---|---|
| Injection site reactions, US, adult weight trials (2.4 mg) [1] | 1% | 1.4% |
| Injection site reactions, Canadian Table 4, STEP 1–3 [3] | 1.0% | 1.4% |
| Injection site reactions, EU SmPC 4.8 [2] | not given | “common” |
| Dysesthesia, US, adults, 7.2 mg trials (Table 4) [1] | 0% | 6% on 2.4 mg, 22% on 7.2 mg |
| Rash and hives, US, adolescents (Table 5) [1] | 0% each | 3% each |
What counts as a site reaction
The US label groups itching (pruritus), redness (erythema), inflammation, hardening of the skin (induration) and irritation at the injection site. [1] The Canadian monograph casts a wider net, adding swelling, hives, tingling at the site and a general “injection site reaction” term, yet arrives at the same 1.4% against 1.0%. [3] The placebo injections caused such reactions in about 1 person in 100, a reminder that the needle and the act of injecting play a part on their own.
None of the three documents says how long site reactions lasted, whether they rose at higher doses, or gives a separate teenage figure.
Skin changes the label keeps separate
- Dysesthesia: altered skin sensations such as tingling, burning, sensitive skin and skin pain, not limited to the injection site. It became more frequent with higher doses and drug levels: 22% on 7.2 mg against 6% on 2.4 mg in the high-dose trials. The Medication Guide calls it “changes in skin sensations”. [1]
- Rash and hives: each in 3% of teenagers on Wegovy® and none on placebo. [1]
- Allergy linked to antibodies: in adult trials, allergic reactions occurred in 16% of people who developed anti-semaglutide antibodies and 7% of those who did not. [1] The EU document says antibodies were found in 2.9–10.9% of people on 2.4 mg and 15.3% on 7.2 mg, were transient and had no apparent effect on efficacy or safety. [2]
- Serious allergic reactions: anaphylaxis and angioedema (swelling under the skin) have been reported; section 5.7 says to stop the medicine if they occur. [1]
What research adds
A 2026 meta-analysis pooled 14 randomised trials of GLP-1 medicines that reported site reactions (4,861 patients, 396 events) and found them about 3.5 times as likely as with comparators (risk ratio 3.55). [4] Broader skin events were infrequent and not significantly raised. In the US FDA voluntary reporting database, the clearest site-reaction signals, such as bleeding at the site, were for exenatide and dulaglutide rather than semaglutide. [4] Disproportionality signals of this kind show reporting patterns, not rates or proof of cause.
Sites and technique in the instructions
Section 2.1 says Wegovy® goes into the fatty layer beneath the skin of the belly, a thigh or an upper arm, that the site should be rotated with each dose, and that the time of day and site can change without changing the dose. [1] Section 12.3 reports similar exposure whichever area is used, and the Medication Guide adds not to inject into a muscle or a vein. [1]
The Instructions for Use for the single-dose pen add practical detail: keep at least 2 inches from the belly button; avoid skin that is tender, bruised, red or hard, and areas with scars or stretch marks; clean the skin with an alcohol swab or soap and water and let it dry; then press the pen firmly and keep pressing until the yellow bar stops moving, which takes about 5 to 10 seconds. If medicine appears on the skin, the instructions say to keep pressure on until the bar stops next time; if blood appears, press the site lightly with gauze or cotton. [1] The FlexTouch® pen instructions ask you to keep pressing the button with the needle in the skin and count slowly to 6. [1]
In the EU, the 7.2 mg dose can be given as one injection or as three 2.4 mg injections in the same body area, at least 5 cm apart. [2] The US label asks that patients be trained on the exact presentation they receive and retrained if it changes. [1]
Other causes, and what general guidance says
Not every red patch is a drug reaction. MedlinePlus describes cellulitis, a skin infection, as redness that gets bigger, warmth, tenderness, a tight or glossy look and sometimes fever, chills and fatigue, and notes that a provider may mark the edge of the redness with a pen to see whether it spreads. [5] Hives, raised itchy bumps, are usually caused by an allergic reaction to a medicine or food; they often go away on their own, but swelling of the airway is an emergency. [6]
Section 5.11 is absolute: a Wegovy® FlexTouch® pen must never be shared, even with a new needle, because of the risk of passing on blood-borne infections. [1] The label does not suggest creams or antihistamines for site reactions; ask your pharmacist or prescriber before using one.
Wegovy® and FlexTouch® are registered trademarks of Novo Nordisk A/S. PepLabo is not affiliated with or endorsed by Novo Nordisk.
When to get help
| Sign | Who to contact | How fast | Source |
|---|---|---|---|
| Trouble breathing or swallowing, a swollen face, lips, tongue or throat, a very fast heartbeat, fainting, or a severe rash or itching | Stop Wegovy® and get emergency help | Emergency | Medication Guide [1]; MedlinePlus [6] |
| Redness that keeps spreading, warm skin, red streaks, pus, or fever and chills | Your provider right away | Today | MedlinePlus [5] |
| Hives or a rash away from the injection site | Your prescriber, the same day | Today | Wegovy® section 5.7 [1]; MedlinePlus [6] |
| Tingling, burning or skin pain that is not limited to the injection site | Your prescriber at the next visit | At your next appointment | Wegovy® section 6.1 [1] |
| A site reaction that keeps coming back, or trouble injecting the full dose | Your prescriber, nurse or pharmacist to review technique | At your next appointment | Wegovy® section 2.1 and Instructions for Use [1] |