Home FDA labels 0af12ae7-bb37-4319-94d1-8074b39d4e1b ZELSUVMI openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name ZELSUVMI
Generic name BERDAZIMER
Manufacturer LNHC, Inc.
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 76b17622-bdb9-41ea-b962-c2acc0df71f7
SPL ID 0af12ae7-bb37-4319-94d1-8074b39d4e1b
Version 3
Effective date 2025-07-08
Source export date 2026-10-12
Source partition 8
Source file https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:18:37 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 14 matching rows.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions 5 WARNINGS AND PRECAUTIONS Application Site Reactions: Application site reactions, including allergic contact dermatitis, occurred. Discontinue ZELSUVMI and initiate appropriate therapy. ( 5.1 ) 5.1 Application Site Reactions Application site reactions, including allergic contact dermatitis, have occurred in patients treated with ZELSUVMI. Suspect allergic contact dermatitis in the event of pain, pruritus, swelling or erythema at the application site lasting longer than 24 hours. If allergic contact dermatitis occurs, discontinue ZELSUVMI and initiate appropriate therapy.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 2 matching rows.
adverse reactions 6 ADVERSE REACTIONS The most commonly reported adverse reactions (≥1%) are application site reactions, including pain (such as burning or stinging sensations, 18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LNHC, Inc. at 1-855-330-7546 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. In three double-blind, vehicle-controlled clinical trials (Trial 1, and Trial 2 and Trial 3, which were similarly designed to Trial 1), 1596 adult and pediatric subjects were treated with ZELSUVMI or vehicle gel topically once daily for up to 12 weeks [see Clinical Studies (14) ]. In these trials 3% of subjects were less than 2 years of age, and 96% of subjects were 2 to 17 years of age. The trial population included 51% male, 88% White, 6% Black, and 6% Other; for ethnicity, 21% of subjects identified as Hispanic/Latino, 78% as non-Hispanic/Latino, and 1% were not reported. Adverse reactions reported by ≥1% of subjects and more frequently than vehicle-treated subjects are listed in Table 1. Table 1: Adverse Reactions Reported by ≥ 1% of Subjects with MC Treated with ZELSUVMI (and Greater than Vehicle) Day 1 through Week 12 in Trials 1, 2, and 3 ZELSUVMI N=916 Vehicle Gel N=680 Adverse Reaction Mild n (%) Moderate n (%) Severe n (%) Mild n (%) Moderate n (%) Severe n (%) Subjects with any TEAE* 220 (24.0) 192 (21.0) 16 (1.7) 118 (17.4) 47 (6.9) 4 (0.6) Application Site Pain† 113 (12.3) 56 (6.1) 2 (0.2) 30 (4.4) 3 (0.4) 0 Application Site Erythema 48 (5.2) 55 (6.0) 4 (0.4) 7 (1.0) 2 (0.3) 0 Application Site Pruritus 36 (3.9) 15 (1.6) 1 (0.1) 5 (0.7) 2 (0.3) 0 Application Site Exfoliation 18 (2.0) 26 (2.8) 2 (0.2) 0 0 0 Application Site Dermatitis 16 (1.7) 26 (2.8) 3 (0.3) 3 (0.4) 2 (0.3) 0 Application Site Swelling 17 (1.9) 14 (1.5) 1 (0.1) 3 (0.4) 1 (0.1) 0 Pyrexia 14 (1.5) 6 (0.7) 0 6 (0.9) 1 (0.1) 0 Application Site Erosion 7 (0.8) 5 (0.5) 3 (0.3) 1 (0.1) 0 0 Application Site Discoloration 13 (1.4) 1 (0.1) 0 1 (0.1) 0 0 Application Site Vesicles 5 (0.5) 9 (1.0) 0 0 1 (0.1) 0 Vomiting 5 (0.5) 7 (0.8) 0 1 (0.1) 0 0 Application Site Irritation 7 (0.8) 4 (0.4) 0 0 0 0 Upper Respiratory Tract Infection 6 (0.7) 5 (0.5) 0 4 (0.7) 1 (0.1) 0 Application Site Infection 4 (0.4) 4 (0.4) 2 (0.2) 2 (0.3) 1 (0.1) 0 * TEAE – treatment emergent adverse events † Application site pain also includes application site burning and stinging.
adverse reactions table <table ID="table1" border="0.5"><caption>Table 1: Adverse Reactions Reported by ≥ 1% of Subjects with MC Treated with ZELSUVMI (and Greater than Vehicle) Day 1 through Week 12 in Trials 1, 2, and 3</caption><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule"/><td styleCode="Botrule Lrule Rrule Toprule" colspan="3" align="center"><content styleCode="bold">ZELSUVMI</content> <content styleCode="bold">N=916</content></td><td styleCode="Botrule Lrule Rrule Toprule" colspan="3" align="center"><paragraph><content styleCode="bold">Vehicle Gel</content></paragraph><paragraph><content styleCode="bold">N=680</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold"><content styleCode="italics">Adverse Reaction </content></content></td><td styleCode="Botrule Lrule Rrule Toprule" align="center"><content styleCode="bold">Mild</content> <content styleCode="bold">n (%)</content></td><td styleCode="Botrule Lrule Rrule Toprule" align="center"><content styleCode="bold">Moderate</content> <content styleCode="bold">n (%) </content></td><td styleCode="Botrule Lrule Rrule Toprule" align="center"><content styleCode="bold">Severe</content> <content styleCode="bold">n (%) </content></td><td styleCode="Botrule Lrule Rrule Toprule" align="center"><content styleCode="bold">Mild</content> <content styleCode="bold">n (%)</content></td><td styleCode="Botrule Lrule Rrule Toprule" align="center"><paragraph><content styleCode="bold">Moderate </content></paragraph><paragraph><content styleCode="bold">n (%) </content></paragraph></td><td styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">Severe</content></paragraph><paragraph><content styleCode="bold">n (%) </content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">Subjects with any TEAE*</content></td><td styleCode="Botrule Lrule Rrule Toprule" align="center"><content styleCode="bold">220 (24.0)</content></td><td styleCode="Botrule Lrule Rrule Toprule" align="center"><content styleCode="bold">192 (21.0)</content></td><td styleCode="Botrule Lrule Rrule Toprule" align="center"><content styleCode="bold">16 (1.7)</content></td><td styleCode="Botrule Lrule Rrule Toprule" align="center"><content styleCode="bold">118 (17.4)</content></td><td styleCode="Botrule Lrule Rrule Toprule" align="center"><content styleCode="bold">47 (6.9)</content></td><td styleCode="Botrule Lrule Rrule Toprule" align="center"><content styleCode="bold">4 (0.6)</content></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Application Site Pain†</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">113 (12.3)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">56 (6.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">2 (0.2)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">30 (4.4)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">3 (0.4) </td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Application Site Erythema</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">48 (5.2)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">55 (6.0)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">4 (0.4)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">7 (1.0)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">2 (0.3)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Application Site Pruritus</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">36 (3.9)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">15 (1.6)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">1 (0.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">5 (0.7)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">2 (0.3)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Application Site Exfoliation</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">18 (2.0)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">26 (2.8)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">2 (0.2)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Application Site Dermatitis</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">16 (1.7)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">26 (2.8)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">3 (0.3)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">3 (0.4)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">2 (0.3)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Application Site Swelling</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">17 (1.9)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">14 (1.5)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">1 (0.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">3 (0.4)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">1 (0.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Pyrexia</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">14 (1.5)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">6 (0.7)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">6 (0.9)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">1 (0.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Application Site Erosion</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">7 (0.8)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">5 (0.5)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">3 (0.3)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">1 (0.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Application Site Discoloration</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">13 (1.4)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">1 (0.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">1 (0.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Application Site Vesicles</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">5 (0.5)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">9 (1.0)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">1 (0.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Vomiting</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">5 (0.5)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">7 (0.8)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">1 (0.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Application Site Irritation</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">7 (0.8)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">4 (0.4)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Upper Respiratory Tract Infection</td><td styleCode="Botrule Lrule Rrule Toprule" align="right"> 6 (0.7) </td><td styleCode="Botrule Lrule Rrule Toprule" align="center">5 (0.5)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">4 (0.7)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">1 (0.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Application Site Infection</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">4 (0.4)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">4 (0.4)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">2 (0.2)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">2 (0.3)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">1 (0.1)</td><td styleCode="Botrule Lrule Rrule Toprule" align="center">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" colspan="7">* TEAE – treatment emergent adverse events † Application site pain also includes application site burning and stinging.</td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.