What the label lists and what reports show
Birch triterpenes side effects
Birch triterpenes's FDA label: “The most common (incidence ≥2%) adverse reactions are application site reactions.” FAERS holds 209 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 wound complication (34 reports).
- No generic listed
Check it at the source: the birch triterpenes FDA label on DailyMed (effective July 24, 2026, Chiesi 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 FILSUVEZ?FILSUVEZ may cause serious side effects including: Allergic reactions. Allergic reactions and skin reactions to FILSUVEZ may include the following symptoms: red itchy bumps (hives), skin rash, redness or itching. If you get any of these symptoms, stop using FILSUVEZ right away and call your healthcare provider. The most common side effect of FILSUVEZ is application site reactions, such as pain and itchy skin. These are not all the possible side effects of FILSUVEZ. 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, Chiesi USA, Inc., effective July 24, 2026 (SPL set 32ba9194-734c-47d4-84e1-b21e28a85ec5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (incidence ≥2%) adverse reactions are application site reactions.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] The most common (incidence ≥2%) adverse reactions are application site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA Inc. at 1-888-661-9260 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 practice. The safety of FILSUVEZ was evaluated in EASE, a randomized, double-blind, multicenter, placebo-controlled trial in 223 adult and pediatric subjects with inherited EB. During the double-blind phase of EASE, subjects received topical treatment with either FILSUVEZ or a placebo gel on partial-thickness wounds every 1 to 4 days for a total of 90 days. Treated wounds were covered with non-adhesive dressings. Following completion of the double-blind phase, all subjects received FILSUVEZ for a total of 24 months during the open-label phase [see Clinical Studies (14) ]. …
Source: FDA drug label, Chiesi USA, Inc., effective July 24, 2026 (SPL set 32ba9194-734c-47d4-84e1-b21e28a85ec5), via openFDA; the full label on DailyMed
What do FAERS reports show?
209 reports list birch triterpenes among the medicines taken, each a report of something that happened, not proof the medicine caused it; 13 are coded as a death and 25 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 17 reactions below, 3 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?
- Birch triterpenes: 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