ORLYNVAH is available through an exclusive partnership with Alto Pharmacy

ORLYNVAH safety profile

ORLYNVAH is safe and well tolerated1-3

The most common adverse reactions reported were gastrointestinal side effects, with the majority being mild in patients taking ORLYNVAH during clinical studies.

Most common adverse reactions (≥ 2%)

Adverse Reaction
ORLYNVAH
N=1932
Amoxicillin/ Clavulanate N=1107
Ciprofloxacin
N=822
Diarrhea (n)10% (194)4% (45)3% (21)
Nausea (n)4% (80)3% (32)4% (30)
Vulvovaginal mycotic infection (n)2% (46)1% (13)1% (7)
Headache (n)2% (42)2% (17)2% (18)
Vomiting (n)2% (29)0.4% (4)1% (11)
ONLY0.3%
experienced serious adverse reactions
Only 0.3% (6/1932) of patients treated with ORLYNVAH experienced serious adverse reactions1
ONLY1%
discontinued treatment
Only 1% (21/1932) of patients treated with ORLYNVAH discontinued treatment1

The most commonly reported adverse reactions leading to discontinuation of ORLYNVAH were nausea (6/1932; 0.3%), diarrhea (5/1932; 0.3%), as well as abdominal pain, gastroesophageal reflux disease, vomiting, and dizziness, each 0.2% (3/1932)1

Consistent clinical response
Demonstrated clinical efficacy against amoxicillin/clavulanate in a Phase 3 clinical trial1,3
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Convenient, at-home dosing
A one pill, twice-daily, 5-day oral treatment1
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References:
  1. ORLYNVAH. Package insert. Iterum Therapeutics U.S. Limited: Chicago, IL; 2025.
  2. Dunne MW, Aronin SI, Das AF, et al. Sulopenem or ciprofloxacin for the treatment of uncomplicated urinary tract infections in women: a phase 3, randomized trial. Clin Infect Dis. 2023;76(1):66-77. doi:10.1093/cid/ciac738
  3. Puttagunta S, Aronin SI, Gupta J, Das AF, Gupta K, Dunne MW. Sulopenem versus amoxicillin/clavulanate for the treatment of uncomplicated urinary tract infection. NEJM Evid. 2025;4(7):EVIDoa2400414. doi:10.1056/EVIDoa2400414