Indigotindisulfonate: uses, dosing, side effects & brands
Indigotindisulfonate is a diagnostic dye sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Diagnostic Dye
- Available as
- Injectable
- Sold as
- Bludigo
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How indigotindisulfonate is dosed
From the FDA label for Bludigo (application NDA216264). Other indigotindisulfonate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dose is 5 mL given intravenously over 1 minute. ( 2.1 ) Monitor blood pressure and heart rhythm during and after injection. ( 2.2 ) 2.1 Recommended Dosage The recommended dose of BLUDIGO is 5 mL given as an intravenous injection over 1 minute. The blue color is detectable at the ureteral orifices within 4 minutes to 9 minutes after the intravenous injection. 2.2 Important Administration Instructions Monitor blood pressure and cardiac rhythm during and following the injection [see Warnings and Precautions ( 5.1 )] . Use immediately after opening ampule. Withdraw the contents of the ampule through a 5 micron or smaller filter straw/filter needle to ensure that the withdrawn solution contains no particulates. The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration. Do not administer with infusion assemblies used with other diluents or drugs. Discard any unused portion.
Indigotindisulfonate side effects
Clinically significant adverse reactions are described elsewhere in the labeling: Cardiovascular Reactions [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Adverse reactions (≥ 1%) are constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1–800-625-1618 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. The safety of BLUDIGO was evaluated in a randomized, intra-patient controlled, blind to dose of BLUDIGO, clinical trial. A total of 118 adult patients undergoing endoscopic urological or gynecological procedures were treated intravenously; 58 (49%) of these patients received one dose of BLUDIGO 2.5 mL and 60 (51%) of patients received one dose of BLUDIGO 5 mL. The 2.5 mL dose is not approved [see Dosage and Administration ( 2.1 )]. The mean age of patients was 51 years and 35 (30%) patients were 65 years of age or older. The majority of patients were White 105 (89%) and female 87 (74%). The adverse reactions (≥1%) reported in…
Who shouldn’t take indigotindisulfonate
BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components [see Warnings and Precautions ( 5.2 )] . Known hypersensitivity to indigotindisulfonate or any of its components. ( 4 )
Every indigotindisulfonate product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Bludigo.
What people report to the FDA about indigotindisulfonate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 3 reports naming indigotindisulfonate, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- anaphylactic reaction1 reports
- cheilitis1 reports
- dermatitis1 reports
- radiation skin injury1 reports
- reaction to excipient1 reports
- stomatitis1 reports
Read these as a signal, not a rate. A report does not mean indigotindisulfonate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is indigotindisulfonate?
Bludigo (Indigotindisulfonate Sodium) is a diagnostic dye.
What kind of drug is indigotindisulfonate?
The FDA classifies indigotindisulfonate as a diagnostic dye. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take indigotindisulfonate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run indigotindisulfonate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does indigotindisulfonate come in?
Across the brands we track, indigotindisulfonate is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic indigotindisulfonate?
We do not currently list a generic-labelled indigotindisulfonate product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Indigotindisulfonate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/indigotindisulfonate
- MLA
- “Indigotindisulfonate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/indigotindisulfonate.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for indigotindisulfonate on DailyMed (NIH) ↗.