Quick answers
- What is Gallium citrate GA-67 used for?
- The FDA-approved label (Gallium Citrate Ga-67, Curium US LLC, August 13, 2025) says: “Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.” 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 Gallium citrate GA-67?
- The “Adverse Reactions” section of the FDA label (Gallium Citrate Ga-67, Curium US LLC, August 13, 2025) begins: “Rare occurrences of allergic reactions, skin rash and nausea have been reported in association with Gallium Citrate Ga 67 use.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gallium citrate GA-67 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 Gallium citrate GA-67?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Gallium citrate GA-67 been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Gallium citrate GA-67?
- 1 company lists prescription products of Gallium citrate GA-67 in the FDA NDC Directory, including Curium US LLC.
What Gallium citrate GA-67 is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.
— FDA label: Gallium Citrate Ga-67, Curium US LLC, effective August 13, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, solution, intravenous), Gallium Citrate Ga-67, Curium US LLC; 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.
Gallium citrate GA-67 side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Rare occurrences of allergic reactions, skin rash and nausea have been reported in association with Gallium Citrate Ga 67 use.
— FDA label: Gallium Citrate Ga-67, Curium US LLC, effective August 13, 2025. Read the full label on DailyMed →
Gallium citrate GA-67 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 Gallium Citrate Ga 67 Injection is 74 to 185 megabecquerels (2 to 5 millicuries). Gallium Citrate Ga 67 Injection is intended for intravenous administration only. Approximately 10 percent of the administered dose is excreted in the feces during the first week after injection.
Read more of this section
Daily laxatives and/or enemas are recommended from the day of injection until the final images are obtained in order to cleanse the bowel of radioactive material and minimize the possibility of false positive studies. Studies indicate the optimal tumor to background concentration ratios are often obtained 48 hours post injection. However, considerable biological variability may occur in individuals and acceptable images may be obtained as early as 6 hours and as late as 120 hours after injection. 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. Do not use if contents are turbid. Instructions for the handling of Gallium Citrate Ga 67: Waterproof gloves should be used during the entire handling and administration procedure. Using proper shielding, the vial containing the Gallium Citrate Ga 67 should be visually inspected to ensure that it is free of particulate matter and discoloration prior to use. Maintain adequate shielding during the life of the product and use a sterile, shielded syringe for withdrawing and injecting the preparation. R adiation Dosimetry The estimated absorbed radiation doses 2 from an intravenous injection of 185 megabecquerels (5 millicuries) of Gallium Citrate Ga 67 are shown in Table 4. Table 4. Absorbed Radiation Doses Tissue mGy/ 185MBq rads/ 5mCi Whole Body Skeleton Liver Bone Marrow Spleen Kidney Ovaries Testes Gastrointestinal Tract Stomach Small Intestine Upper Large Intestine Lower Large Intestine 13.0 22.0 23.0 29.0 26.5 20.5 14.0 12.0 11.0 18.0 28.0 45.0 1.30 2.20 2.30 2.90 2.65 2.05 1.40 1.20 1.10 1.80 2.80 4.50 2 MIRD Dose Estimate Report No. 2, J. Nucl. Med. 14; 755-6 (1973).
Table from the label
| Tissue | mGy/ 185MBq | rads/ 5mCi |
|---|---|---|
| Whole Body Skeleton Liver Bone Marrow Spleen Kidney Ovaries Testes Gastrointestinal Tract Stomach Small Intestine Upper Large Intestine Lower Large Intestine | 13.0 22.0 23.0 29.0 26.5 20.5 14.0 12.0 11.0 18.0 28.0 45.0 | 1.30 2.20 2.30 2.90 2.65 2.05 1.40 1.20 1.10 1.80 2.80 4.50 |
— FDA label: Gallium Citrate Ga-67, Curium US LLC, effective August 13, 2025. Read the full label on DailyMed →
Gallium citrate GA-67 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.
Animal reproductive studies have not been conducted with Gallium Citrate Ga 67. It is also not known whether Gallium Citrate Ga 67 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gallium Citrate Ga 67 should be given to a pregnant woman only if clearly needed.
Read more of this section
Ideally, examinations using radiopharmaceuticals, especially those elective in nature of women of childbearing capability, should be performed during the first few (approximately ten) days following the onset of menses.
— FDA label: Gallium Citrate Ga-67, Curium US LLC, effective August 13, 2025. Read the full label on DailyMed →
Gallium citrate GA-67 and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
This drug is known to be excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feedings.
— FDA label: Gallium Citrate Ga-67, Curium US LLC, effective August 13, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 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.
- Curium US LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018058 GALLIUM CITRATE GA 67 | Curium | February 1, 1979 | 9, latest March 19, 2014 2014: Manufacturing (CMC) · 1985: Manufacturing (CMC) · 1984: 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 | 5f670c12-cca5-4d73-8a88-241f753d1bc7 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA018058 |
| Active ingredients (FDA) | GALLIUM CHLORIDE GA-67 |
Next steps
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Gallium Citrate Ga-67, Curium US LLC, effective August 13, 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 →