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Indigo Carmine

Indigo carmine (indigotindisulfonate sodium) is a visible blue urinary dye. BLUDIGO received initial US approval in 2022 and has a current prescribing label; the shortage that began in June 2014 is over. It is indicated as a visualization aid during cystoscopic assessment of ureteral integrity in adults after urological or gynecological open, robotic or endoscopic surgery.[1] Confirm local supply and formulary access; DailyMed lists BLUDIGO labels from Provepharm and Sagent.

Pharmacology and administration​

ItemCurrent US BLUDIGO information
Formulation40 mg/5 mL (8 mg/mL), single-dose ampule[1]
Adult dose5 mL IV over 1 minute[1]
ExcretionRenal, including tubular secretion
Ureteral effluxLabel: blue color detectable at the ureteral orifices about 4–9 minutes after injection; timing varies with renal function and urine flow
PreparationUse immediately after opening; withdraw through a 5-micron or smaller filter needle; inspect for particulates; discard the remainder
Renal impairmentNo adjustment for eGFR 30–89 mL/min; not recommended with eGFR <30 mL/min[1]

Do not give through infusion assemblies used with other diluents or drugs. The label describes a single 5 mL dose; a routine repeat dose is not established.[1]

What the examination establishes​

Blue efflux helps identify ureteral orifices and assess urine passage at that moment. In an intra-patient trial of 118 adults undergoing urologic or gynecologic surgery, participants received saline and were randomized to 2.5 or 5 mL of indigo carmine; the approved 5-mL dose (60 adults; 96 ureters evaluated) had higher blinded video scores for efflux conspicuity than saline (P < .0001).[1][11] Persistent suspicion requires direct assessment and appropriate imaging or retrograde evaluation, even if efflux is seen.[2]

In a prospective universal-cystoscopy series of 839 benign hysterectomies, ureteral injury occurred in 15 patients (1.8%), most often near the uterine artery; kinking and transection were the most frequent types.[4] Reduced dye efflux alone was not associated with injury in that series.[4] In a 2015 meta-analysis of 79 mostly retrospective studies of benign gynecologic surgery, routine cystoscopy was associated with higher intraoperative detection of urinary tract injuries. Postoperatively detected ureteric injuries were estimated at 1.6 per 1,000 operations without routine cystoscopy versus 0.7 with it; the authors judged the difference small.[5] The 2018 AUGS consensus recommends universal intraoperative cystoscopy during pelvic organ prolapse reconstructive surgery except for operations solely involving posterior-compartment defects.[10] Choose an efflux aid according to patient contraindications and local availability.[1]

Indigo carmine does not provide the same through-tissue NIR mapping as retrograde ICG.

For a double-dye fistula examination, the usual distinction is oral phenazopyridine-colored upper-tract urine versus intravesical methylene blue. Adding IV blue dye can confuse that color distinction. Use the clinical vesicovaginal fistula evaluation pathway.

Safety​

  • Contraindicated: hypersensitivity to indigotindisulfonate or a product component.
  • Cardiovascular reactions: severe hypertension or hypotension, arrhythmia, conduction abnormalities and cardiac arrest have been reported, generally within 60 minutes. Patients with hypertension, heart-rate or conduction disorders, or medications that cause bradycardia may be at increased risk of blood-pressure elevation, hypotension or bradycardia. Monitor blood pressure and rhythm during and after injection; interrupt administration if a reaction occurs.[1]
  • Anaphylaxis: monitor and have trained personnel and emergency equipment available.[1]
  • Pulse oximetry: may transiently underestimate oxygen saturation. Assess the patient and obtain an appropriate alternative measurement when needed rather than dismissing a low reading.[1]
  • Pregnancy: available reports, mostly after intra-amniotic injection, have not identified a drug-associated maternal or fetal risk; data are insufficient to assess risk from IV administration, especially in the first trimester. Pediatric safety and effectiveness are not established in the US label.[1]

Historical shortage and alternatives​

The 2014 shortage prompted evaluation of fluorescein, phenazopyridine and bladder-distension techniques. Doyle's report used 0.25–1 mL of 10% sodium fluorescein (25–100 mg) IV as an off-label aid.[3] In a 130-patient randomized trial (unblinded, surgeon-satisfaction endpoint), mannitol bladder distention was rated best, ahead of saline, fluorescein 25 mg IV and oral phenazopyridine 200 mg; adverse events did not differ.[6] In a 12-patient pelvic reconstructive surgery cohort, colored urine appeared in an indwelling catheter at a median of 5 minutes after fluorescein 50 mg IV (n = 5), versus 70 minutes after phenazopyridine 200 mg orally (n = 7).[7] Select alternatives according to the purpose, safety profile and local availability. Pudexacianinium (ASP5354), an investigational near-infrared fluorescent ureter-visualization agent, has published phase 2 data from 12 colorectal-surgery patients; two phase 3 studies completed in 2025.[8][9]

See Also​

References​

1. BLUDIGO (indigotindisulfonate sodium injection). US prescribing information (Provepharm), revised November 2025. DailyMed. A Sagent label with matching text is also listed.

2. de'Angelis N, Schena CA, Marchegiani F, et al. 2023 WSES guidelines for prevention, detection and management of iatrogenic urinary tract injuries during emergency digestive surgery. World J Emerg Surg. 2023;18:45. doi:10.1186/s13017-023-00513-8.

3. Doyle PJ, Lipetskaia L, Duecy E, Buchsbaum G, Wood RW. Sodium fluorescein use during intraoperative cystoscopy. Obstet Gynecol. 2015;125(3):548–550. doi:10.1097/AOG.0000000000000675.

4. Ibeanu OA, Chesson RR, Echols KT, et al. Urinary tract injury during hysterectomy based on universal cystoscopy. Obstet Gynecol. 2009;113(1):6-10. doi:10.1097/AOG.0b013e31818f6219

5. Teeluckdharry B, Gilmour D, Flowerdew G. Urinary Tract Injury at Benign Gynecologic Surgery and the Role of Cystoscopy: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015;126(6):1161-1169. doi:10.1097/AOG.0000000000001096

6. Grimes CL, Patankar S, Ryntz T, et al. Evaluating ureteral patency in the post-indigo carmine era: a randomized controlled trial. Am J Obstet Gynecol. 2017;217(5):601.e1-601.e10. doi:10.1016/j.ajog.2017.07.012

7. Cohen SA, Chaudhry Z, Oliver JL, et al. Comparison of Times to Ureteral Efflux after Administration of Sodium Fluorescein and Phenazopyridine. J Urol. 2017;197(2):519-523. doi:10.1016/j.juro.2016.07.099

8. Albert M, Delgado-Herrera L, Paruch J, et al. Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic, minimally invasive colorectal surgery. Surg Endosc. 2023;37(9):7336-7347. doi:10.1007/s00464-023-10193-9

9. Kojima T, Saito M, Matsuda T, et al. "Effects of renal impairment on the pharmacokinetics, safety, and tolerability of pudexacianinium (ASP5354) after IV administration: a mechanistic exploration." Eur J Clin Pharmacol. 2026;82:131. doi:10.1007/s00228-026-04063-1

10. Cohen SA, Carberry CL, Smilen SW. "American Urogynecologic Society consensus statement: cystoscopy at the time of prolapse repair." Female Pelvic Med Reconstr Surg. 2018;24(4):258-259. doi:10.1097/SPV.0000000000000529

11. Lepor H, Wiegand L, Patel K, Du W, Gagnon S; 19IC01 Investigators. "A randomized clinical trial evaluating indigo carmine as a visualization aid for evaluating ureteral patency." Urology. 2024;184:105-111. doi:10.1016/j.urology.2023.11.005