Quick answers
- What is Indium IN-111 pentetate disodium used for?
- The FDA-approved label (Indium DTPA In 111, Medi-Physics, Inc. dba GE Healthcare, January 10, 2024) says: “Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.” 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 Indium IN-111 pentetate disodium?
- The “Adverse Reactions” section of the FDA label (Indium DTPA In 111, Medi-Physics, Inc. dba GE Healthcare, January 10, 2024) begins: “Aseptic meningitis and pyrogenic reactions have been rarely (less than 0.4%) observed following cisternography with Pentetate lndium Disodium In 111. One death has been reported to have occurred within 20 minutes following the administration of Pentetate Indium Disodium In 111 and appears to be drug related. In addition, two cases of septic meningitis have also been reported.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Indium IN-111 pentetate disodium have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Indium IN-111 pentetate disodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Indium IN-111 pentetate disodium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Indium IN-111 pentetate disodium?
- 1 company lists prescription products of Indium IN-111 pentetate disodium in the FDA NDC Directory, including Medi-Physics Inc. dba GE Healthcare.
What Indium IN-111 pentetate disodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.
— FDA label: Indium DTPA In 111, Medi-Physics, Inc. dba GE Healthcare, effective January 10, 2024. Read the full label on DailyMed →
Label quoted: the one for the most common form (solution, intrathecal), Indium DTPA In 111, Medi-Physics, Inc. dba GE Healthcare; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
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.
Indium IN-111 pentetate disodium side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Aseptic meningitis and pyrogenic reactions have been rarely (less than 0.4%) observed following cisternography with Pentetate lndium Disodium In 111. One death has been reported to have occurred within 20 minutes following the administration of Pentetate Indium Disodium In 111 and appears to be drug related. In addition, two cases of septic meningitis have also been reported.
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There have also been reports of skin reactions and vomiting following administration of Pentetate lndium Disodium In 111. Relationship of the drug to these latter occurrences has not been established.
— FDA label: Indium DTPA In 111, Medi-Physics, Inc. dba GE Healthcare, effective January 10, 2024. Read the full label on DailyMed →
Indium IN-111 pentetate disodium 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.
Extreme care must be exercised to assure aseptic conditions in intrathecal injections. The maximum recommended intrathecal dose in the average patient (70 kg) is 18.5 MBq, 500 µ Ci. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
— FDA label: Indium DTPA In 111, Medi-Physics, Inc. dba GE Healthcare, effective January 10, 2024. Read the full label on DailyMed →
Indium IN-111 pentetate disodium in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Category C Animal reproduction studies have not been conducted with GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111. Also, it is not known whether Pentetate Indium Disodium In 111 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentetate Indium Disodium In 111 should be given to a pregnant woman only if clearly needed.
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Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.
— FDA label: Indium DTPA In 111, Medi-Physics, Inc. dba GE Healthcare, effective January 10, 2024. Read the full label on DailyMed →
Indium IN-111 pentetate disodium and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, formula feedings should be substituted for breast feedings when Pentetate Indium Disodium In 111 is administered to a nursing mother.
— FDA label: Indium DTPA In 111, Medi-Physics, Inc. dba GE Healthcare, effective January 10, 2024. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Intrathecal |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Indium Dtpa in 111 |
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.
- Medi-Physics Inc. dba GE Healthcare.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017707 MPI INDIUM DTPA IN 111 | Ge Healthcare | February 18, 1982 | 8, latest December 22, 2016 2016: Manufacturing (CMC) · 2004: Labeling · 2002: Manufacturing (CMC) |
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 | 4fea5871-b515-4f69-a297-11507ddd7817 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA017707 |
| Active ingredients (FDA) | INDIUM IN-111 PENTETATE DISODIUM |
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
- Medi-Physics Inc. dba GE Healthcare.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Indium DTPA In 111, Medi-Physics, Inc. dba GE Healthcare, effective January 10, 2024; 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 →