Technetium Tc 99m Medronate

openFDA label record#

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Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Technetium Tc 99m Medronate
Generic name
TECHNETIUM TC 99M MEDRONATE
Manufacturer
Jubilant DraxImage Inc., dba Jubilant Radiopharma
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
3c91d0d8-6cc5-834c-bda0-aa83a873b9fb
SPL ID
71674538-1da8-436f-be11-7e964a2c5b05
Version
4
Effective date
2025-03-05
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:42:06
Harmonized routes table
Harmonized routes
INTRAVENOUS

Warnings cross-check#

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warnings

WARNINGS This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or who may be predisposed to, hypocalcemia (i.e., alkalosis). The contents of the kit before preparation are not radioactive. However, after the sodium pertechnetate Tc-99m is added, adequate shielding of the final preparation must be maintained. Preliminary reports indicate impairment of brain images using Sodium Pertechnetate Tc 99m Injection which have been preceded by bone imaging using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain images. It is recommended, where feasible, that brain imaging using Sodium Pertechnetate Tc 99m Injection precede bone imaging procedures. Alternatively, a brain imaging agent such as technetium Tc-99m pentetate may be employed. The biodistribution of technetium Tc 99m medronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. High levels of these cations may be caused by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.). Most cases were observed after iron infusion. (See PRECAUTIONS, Drug Interactions. )

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Several cases of allergic dermatological reactions have been reported in association with the use of Technetium Tc 99m Medronate. Several reactions have also been reported in association with other radiopharmaceuticals of the diphosphonate class, particularly Technetium Tc 99m Medronate. These are usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea, fever, and vomiting. One death secondary to cardiac arrhythmia following the administration of Technetium Tc 99m Medronate has been reported. In addition, one case of cardiac arrest in a patient also undergoing pulmonary function testing one and one-half hours after the performance of a bone scan using Technetium Tc 99m Medronate has been reported.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.