What the label lists and what reports show
Vyjuvek side effects
Vyjuvek's FDA label: “The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose.” FAERS holds 129 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 pruritus (11 reports).
- No generic listed
Check it at the source: the vyjuvek FDA label on DailyMed (effective September 29, 2025); 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 VYJUVEK Gel?…The most common side effects of VYJUVEK gel are itching, chills, redness, rash, cough, and runny nose. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Krystal Biotech, Inc., effective September 29, 2025 (SPL set fe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reactions | Patients n (%) |
|---|---|
| Itching | 3 (10) |
| Chills | 3 (10) |
| Redness | 2 (6) |
| Rash | 2 (6) |
| Cough | 2 (6) |
| Runny Nose | 2 (6) |
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 most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose. The most common adverse drug reactions (incidence >5%) were itching, chills, redness, rash, cough, and runny nose. (6) To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or http://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 practice. The safety data described in this section reflects exposure to VYJUVEK gel in a randomized, intra-patient placebo‑controlled study. A total of 31 patients with dystrophic epidermolysis bullosa (DEB), including 30 patients with autosomal recessive DEB and one patient with autosomal dominant DEB received topical administration of VYJUVEK gel to their wounds. The age of the patients ranged from 1 year to 44 years (mean age 17 years). Of the 31 patients, 19 (61%) were pediatric patients (less than 17 years of age), and 11 (36%) were females. Each patient received weekly topical application of VYJUVEK gel at one or more wound sites and placebo at a matching wound site as an intra-subject comparator. …
Source: FDA drug label, Krystal Biotech, Inc., effective September 29, 2025 (SPL set fe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c2), via openFDA; the full label on DailyMed
What do FAERS reports show?
129 reports list vyjuvek among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 15 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 23 reactions below, 2 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.
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?
- Vyjuvek: 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