Tiopronin
Other Urologicals
Sold as VENXXIVA
- Drug class
- Other Urologicals
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 1
- Products on record
- 1
- FDA reports (12 mo)
- 172
Overview
Plain-language summary, compiled from the cited regulatory records
Tiopronin is an active pharmaceutical ingredient classified as an "Other Urological" agent [1]. It is approved for use in adults and pediatric patients aged 9 years and older who have severe homozygous cystinuria [1]. Tiopronin is intended for use in combination with high fluid intake, alkali, and diet modification to prevent cystine stone formation in patients who have not responded adequately to these measures alone [1].
Tiopronin is available under various brand names, including VENXXIVA [1]. In the past 12 months, there have been 172 adverse event reports associated with tiopronin [2]. The most frequently reported adverse events include reports of the drug being ineffective, nausea, diarrhea, fatigue, and joint pain (arthralgia) [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | December 22, 2025 |
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE VENXXIVA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone.
Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin delayed-release) tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information.
VENXXIVA is a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone.
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Sources & citations
- [1]FDA DailyMed · 02e24443-04c6-4b… · revised December 22, 2025 [PDF]
- [2]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.