Pivmecillinam (Pivya) for Uncomplicated Urinary Tract Infections in Female Patients

Sara Diletti-Swenson; Emily Feng

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STEPS

New Drug Reviews

Pivmecillinam (Pivya) for Uncomplicated Urinary Tract Infections in Female Patients

Sara Diletti-Swenson, MD

Emily Feng, MD

American Family Physician. 2026;113(5):504-505.

Author disclosure: No relevant financial relationships.

Drug	Dosage	Dose form	Cost^*
Pivmecillinam (Pivya)	185 mg, 3 times/day	185-mg tablet	$940

*—Estimated retail price of 3 days of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed March 11, 2026; zip code: 66211).

Pivmecillinam (Pivya) is a beta-lactam antibiotic in the penicillin drug class. It is labeled for treatment in adult women with uncomplicated cystitis that is caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

SAFETY

As with other penicillins, the main safety concern of pivmecillinam is hypersensitivity reactions. It is contraindicated in patients with a history of serious reactions (eg, anaphylaxis, Stevens-Johnson syndrome) to pivmecillinam or other beta-lactam antibiotics.¹ Pivmecillinam has been linked with acute porphyria, and patients with this condition should not take it. Pivmecillinam also has been associated with carnitine depletion and should not be used in patients with carnitine deficiency. Pivmecillinam should not be used in patients taking valproic acid or valproate because these medications may also cause symptoms of carnitine depletion. Patients with significant kidney impairment or decreased muscle mass should not take pivmecillinam because of the risk of reduced serum carnitine.¹

Similar to other antibiotics, pivmecillinam has been associated with development of Clostridioides difficile–associated diarrhea. As with other penicillins, pivmecillinam may decrease clearance of methotrexate and, where possible, combination should be avoided.¹

TOLERABILITY

Pivmecillinam is well tolerated. The most common adverse effects are nausea (4.3%) and diarrhea (2.1%).¹ Vulvovaginal symptoms occur in less than 2% of patients.¹

EFFECTIVENESS

Pivmecillinam has been studied in three trials at the approved dose, comparing it with cephalexin or no antibiotic treatment in patients with uncomplicated urinary tract infection (UTI).^2–5 In a study of 271 symptomatic participants with documented UTI primarily caused by E coli, clinical or microbiologic response occurred in 62% of those treated with pivmecillinam for 7 days vs 10% of those who received placebo.⁵

Similarly, in a study of 224 nonpregnant women with UTI symptoms lasting fewer than 7 days but without further work-up (eg, no urine dipstick or urine culture), treatment with pivmecillinam for 3 days produced a clinical or microbiologic response in 66% of women at day 14 compared with 22% of those who received only ibuprofen.^1,3 In a randomized study of 259 women with confirmed positive urine cultures primarily caused by E coli, clinical or microbiologic response occurred in 72% of women treated with pivmecillinam for 3 days vs 76% treated with cephalexin for 7 days.^1,4

Pivmecillinam has not been tested for treatment of complicated UTI, in pregnant patients, or for any other infection. Although it has been directly compared with cephalexin, it has not been compared with more commonly used treatments such as nitrofurantoin, fosfomycin, or trimethoprim/sulfamethoxazole. Although pivmecillinam has in vitro activity against other gram-negative aerobes, it has not been studied for these infections.

PRICE

The cost of pivmecillinam is approximately $940 for a 3-day course of nine 185-mg tablets or $2,200 for a 7-day course without any additional associated costs. In comparison, a 5-day course of nitrofurantoin costs about $20.

SARA DILETTI-SWENSON, MD, and EMILY FENG, MD, Tufts University School of Medicine, Boston, Massachusetts

Address correspondence to Sara Diletti-Swenson, MD, at sdilettiswenson@challiance.org.

Author disclosure: No relevant financial relationships.

1.US Food and Drug Administration. Pivya (pivmecillinam) tablets, for oral use [package insert]. April 2024. Accessed April 28, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216483s000lbl.pdf
2.Bjerrum L, Gahrn-Hansen B, Grinsted P. Pivmecillinam versus sulfamethizole for short-term treatment of uncomplicated acute cystitis in general practice: a randomized controlled trial. Scand J Prim Health Care. 2009;27(1):6-11.
3.Vik I, Bollestad M, Grude N, et al. Ibuprofen versus pivmecillinam for uncomplicated urinary tract infection in women—a double-blind, randomized non-inferiority trial. PLoS Med. 2018;15(5):e1002569.
4.Menday AP. Comparison of pivmecillinam and cephalexin in acute uncomplicated urinary tract infection. Int J Antimicrob Agents. 2000;13(3):183-187.
5.Ferry SA, Holm SE, Stenlund H, et al. Clinical and bacteriological outcome of different doses and duration of pivmecillinam compared with placebo therapy of uncomplicated lower urinary tract infection in women: the LUTIW project. Scand J Prim Health Care. 2007;25(1):49-57.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.