Vtama Side Effects

6 ADVERSE REACTIONS In 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.

Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with VTAMA cream, and for which the rate exceeded the rate for vehicle.

Table 1: Adverse Reactions Occurring in ≥1% of Adult Subjects with Plaque Psoriasis (and More Frequently than Vehicle) in the 12-week PSOARING 1 and PSOARING 2 Clinical Trials Adverse Reaction VTAMA cream N=683 n (%) Vehicle cream N=342 n (%) Folliculitis Folliculitis includes application site folliculitis and folliculitis 140 (20) 3 (1) Nasopharyngitis Nasopharyngitis includes nasopharyngitis, nasal congestion, pharyngitis, respiratory tract infection (RTI) viral, rhinorrhea, sinus congestion, upper RTI, and viral upper RTI 73 (11) 31 (9) Contact dermatitis Contact dermatitis includes dermatitis, contact dermatitis, hand dermatitis, and rash 45 (7) 2 (1) Headache Headache includes headache, migraine, and tension headache 26 (4) 5 (1) Pruritus Pruritus includes application site pruritus, pruritus, generalized pruritus, and genital pruritus 20 (3) 2 (1) Influenza Influenza includes influenza and influenza-like illness 14 (2) 2 (1) Two (0.3%) subjects using VTAMA cream developed urticaria.