Quick answers
- What is Diatrizoate meglumine used for?
- The FDA-approved label (Cystografin, Bracco Diagnostics Inc, November 23, 2025) says: “INDICATION Cystografin is indicated for retrograde cystourethrography.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Diatrizoate meglumine?
- The “Adverse Reactions” section of the FDA label (Cystografin, Bracco Diagnostics Inc, November 23, 2025) begins: “Retrograde genitourinary procedures may cause such complications as hematuria, perforation of the urethra or bladder, introduction of infection into the genitourinary tract, and oliguria or anuria. If intravasation of this drug occurs, the reactions which may be associated with intravenous administration may possibly be encountered. Hypersensitivity or anaphylactoid reactions may occur.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Diatrizoate meglumine have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Diatrizoate meglumine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Diatrizoate meglumine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Diatrizoate meglumine?
- 1 company lists prescription products of Diatrizoate meglumine in the FDA NDC Directory, including Bracco Diagnostics Inc.
What Diatrizoate meglumine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATION Cystografin is indicated for retrograde cystourethrography.
— FDA label: Cystografin, Bracco Diagnostics Inc, effective November 23, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, solution, intravenous), Cystografin, Bracco Diagnostics Inc; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Diatrizoate meglumine side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Retrograde genitourinary procedures may cause such complications as hematuria, perforation of the urethra or bladder, introduction of infection into the genitourinary tract, and oliguria or anuria. If intravasation of this drug occurs, the reactions which may be associated with intravenous administration may possibly be encountered. Hypersensitivity or anaphylactoid reactions may occur.
Read more of this section
Severe reactions may be manifested by edema of the face and glottis, respiratory distress, convulsions or shock; such reactions may prove fatal unless promptly controlled by such emergency measures as maintenance of a clear airway and immediate use of oxygen and resuscitative drugs. Endocrine: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants. Some patients were treated for hypothyroidism.
— FDA label: Cystografin, Bracco Diagnostics Inc, effective November 23, 2025. Read the full label on DailyMed →
Diatrizoate meglumine dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Preparation of the patient: Appropriate preparation is desirable for optimal results. A laxative the night before the examination and a low residue diet the day before the procedure are recommended. Dosage: The dose for retrograde use in cystography and voiding cystourethrography ranges from 25 to 300 mL depending on the age of the patient and the degree of bladder irritability; amounts greater than 300 mL may be used if the bladder capacity allows.
Read more of this section
Best results are obtained when the bladder is filled with the contrast agent. If desired, the preparation may be diluted with sterile water or sterile saline as indicated in the table below. Administration: After sterile catheterization, the bladder should be filled to capacity with Cystografin using a suitable sterile administration set. Care should be taken to avoid using excessive pressure. The presence of bladder discomfort or reflux and/or spontaneous voiding usually indicates that the bladder is full. Radiography: The commonly employed radiographic techniques should be used. A scout film is recommended before the contrast agent is administered. Dilution Table USE DILUTED SOLUTIONS IMMEDIATELY 100 mL Bottle Sterile Water or Sterile Saline Added % Diatrizoate Meglumine w/v % Organically Bound Iodine w/v Total Volume 0 mL 30.0 14.1 100 mL 25 mL 24.0 11.3 125 mL 50 mL 20.0 9.4 150 mL 67 mL 18.0 8.5 167 mL 300 mL Bottle Sterile Water or Sterile Saline Added 0 mL 30.0 14.1 300 mL 50 mL 25.7 12.1 350 mL
— FDA label: Cystografin, Bracco Diagnostics Inc, effective November 23, 2025. This is part of the section. Read the full label on DailyMed →
When Diatrizoate meglumine should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.
— FDA label: Cystografin, Bracco Diagnostics Inc, effective November 23, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous · Intravesical |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Cystografin, Cystografin Dilute |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bracco Diagnostics Inc2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA010040 CYSTOGRAFIN, CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE, RENO-30, RENO-60, RENO-DIP | Bracco | August 2, 1955 | 95, latest July 6, 2015 2015: Labeling · 2003: Labeling · 2002: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 7496d736-9f7d-4136-ad5d-b24c7803c21b |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA010040 |
| Active ingredients (FDA) | DIATRIZOATE MEGLUMINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- CystografinBrand page: products, maker and price
- Cystografin DiluteBrand page: products, maker and price
- Bracco Diagnostics IncMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cystografin, Bracco Diagnostics Inc, effective November 23, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →