Quick answers
- What is Indium IN-111 oxyquinoline used for?
- The FDA-approved label (Indium In 111 Oxyquinoline, BWXT Medical Ltd., November 1, 2024) says: “Indium In 111 oxyquinoline is indicated for radiolabeling autologous leukocytes. Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures. …” 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 oxyquinoline?
- The “Adverse Reactions” section of the FDA label (Indium In 111 Oxyquinoline, BWXT Medical Ltd., November 1, 2024) begins: “Sensitivity reactions (urticaria) have been reported. The presence of fever may mask pyrogenic reactions from indium In 111 oxyquinoline labeled leukocytes. The possibility of delayed adverse reactions has not been studied.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Indium IN-111 oxyquinoline 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 Indium IN-111 oxyquinoline?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Indium IN-111 oxyquinoline been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Indium IN-111 oxyquinoline?
- 2 companies list prescription products of Indium IN-111 oxyquinoline in the FDA NDC Directory, including BWXT Medical Ltd. and Medi-Physics Inc. dba GE Healthcare.
What Indium IN-111 oxyquinoline is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Indium In 111 oxyquinoline is indicated for radiolabeling autologous leukocytes. Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures. …
— FDA label: Indium In 111 Oxyquinoline, BWXT Medical Ltd., effective November 1, 2024. Read the full label on DailyMed →
Label quoted: the one for the most common form (liquid, intravenous), Indium In 111 Oxyquinoline, BWXT Medical Ltd.; 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.
Indium IN-111 oxyquinoline side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Sensitivity reactions (urticaria) have been reported. The presence of fever may mask pyrogenic reactions from indium In 111 oxyquinoline labeled leukocytes. The possibility of delayed adverse reactions has not been studied.
— FDA label: Indium In 111 Oxyquinoline, BWXT Medical Ltd., effective November 1, 2024. Read the full label on DailyMed →
Indium IN-111 oxyquinoline 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.
The recommended adult (70 kg) dose of indium In 111 oxyquinoline labeled autologous leukocytes is 7.4 to 18.5 MBq, 200-500 µCi. Indium In 111 oxyquinoline solution is intended for the radiolabeling of autologous leukocytes. The indium In 111 oxyquinoline labeled autologous leukocytes are administered intravenously. Imaging is recommended at approximately 24 hours post injection.
Read more of this section
Typically, anterior and posterior views of the chest, abdomen and pelvis should be obtained with other views as required. Aseptic procedures and a shielded syringe should be employed in the withdrawal of indium In 111 oxyquinoline from the vial. Similar procedures should be employed during the labeling procedure and the administration of the labeled leukocytes to the patient. The user should wear waterproof gloves during the entire procedure. The patient's dose should be measured by a suitable radioactivity calibration system immediately before administration. At this time, the leukocyte preparation should be checked for gross clumping and red blood cell contamination.
— FDA label: Indium In 111 Oxyquinoline, BWXT Medical Ltd., effective November 1, 2024. Read the full label on DailyMed →
Indium IN-111 oxyquinoline and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
It is reported that indium 111 is secreted in human milk following administration of indium In 111 labeled leukocytes. Therefore, formula feedings should be substituted for breast feedings.
— FDA label: Indium In 111 Oxyquinoline, BWXT Medical Ltd., effective November 1, 2024. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Liquid · Solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
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.
- BWXT Medical Ltd.1 product
- Medi-Physics Inc. dba GE Healthcare.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019044 INDIUM IN 111 OXYQUINOLINE | Ge Healthcare | December 24, 1985 | 17, latest December 12, 2022 2022: Labeling · 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
Generic approvals (1)
- ANDA202586Bwxt Itg · July 25, 2018
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 | 7dbfc0f9-0e2e-4aed-85bd-32cf7c74d402 |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA019044, 1 ANDA |
| Active ingredients (FDA) | INDIUM IN-111 OXYQUINOLINE |
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
- BWXT Medical Ltd.Maker or distributor
- 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 In 111 Oxyquinoline, BWXT Medical Ltd., effective November 1, 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 →