What the label lists and what reports show
Tapinarof side effects
Tapinarof's FDA label: “In plaque psoriasis, the most common adverse reactions (incidence ≥ 1%) were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.” FAERS holds 1,751 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 folliculitis (283 reports).
- No generic listed
Check it at the source: the tapinarof FDA label on DailyMed (effective May 28, 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 VTAMA cream?The most common side effects of VTAMA cream in people treated for plaque psoriasis include: red raised bumps around the hair pores (folliculitis) pain or swelling in the nose and throat (nasopharyngitis) skin rash or irritation including itching and redness, peeling, burning, or stinging headache flu The most common side effects of VTAMA cream in people treated for atopic dermatitis include: upper and lower respiratory tract infections red raised bumps around the hair pores (folliculitis) headache asthma vomiting ear infection pain in extremity stomach-area (abdominal) pain VTAMA cream can also cause skin reactions at the treatment site. Tell your healthcare provider if you have itching, irritation, pain, redness, burning or changes in skin color at the treatment site. These are not all the possible side effects of VTAMA cream. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, Organon LLC, effective May 28, 2025 (SPL set 9309d20f-8cd4-4c96-93fa-7f730e83c7ab), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn plaque psoriasis, the most common adverse reactions (incidence ≥ 1%) were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
Table 2: Adverse Reactions Occurring in ≥1% of Adult and Pediatric Subjects 2 Years and Older with Atopic Dermatitis (and More Frequently than Vehicle) in the 8 week ADORING 1 and ADORING 2 Clinical Trials
| Adverse Reaction | VTAMA cream N=541 n (%) | Vehicle cream N=270 n (%) |
|---|---|---|
| Upper respiratory tract infection Upper respiratory tract infection includes upper… | 66 (12) | 15 (6) |
| Folliculitis Folliculitis includes folliculitis, application site folliculitis, keratosis… | 51 (9) | 3 (1) |
| Lower respiratory tract infection Lower respiratory tract infection includes lower… | 25 (5) | 6 (2) |
| Headache | 23 (4) | 3 (1) |
| Asthma Asthma includes asthma, wheezing | 12 (2) | 1 (0) |
| Vomiting | 10 (2) | 2 (1) |
| Ear infection Ear infection includes ear infection, otitis media, otitis externa, otitis… | 10 (2) | 1 (0) |
| Pain in extremity Pain in extremity includes pain in extremity, arthralgia | 9 (2) | 1 (0) |
| Abdominal pain Abdominal pain includes abdominal pain and abdominal pain upper | 6 (1) | 0 (0) |
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, continuedIn plaque psoriasis, the most common adverse reactions (incidence ≥ 1%) were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza. ( 6.1 ) In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 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. Plaque Psoriasis Clinical Trials In two randomized, double-blind, multicenter, vehicle-controlled clinical trials (PSOARING 1 and PSOARING 2), 1025 adults with plaque psoriasis were treated with VTAMA cream or received vehicle cream once daily for up to 12 weeks. Subjects ranged in age from 18 to 75 years, with an overall median age of 51 years. The majority of subjects were White (85%) and male (57%); and 85% identified as non-Hispanic or Latino. …
Source: FDA drug label, Organon LLC, effective May 28, 2025 (SPL set 9309d20f-8cd4-4c96-93fa-7f730e83c7ab), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,751 reports list tapinarof among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 60 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 22 reactions below, 9 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.
Reports received each year
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?
- Tapinarof: 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