choletec
Choletec (Technetium Tc-99m Mebrofenin Kit) is a medication supplied as an injection, powder, lyophilized, for solution.
Technetium Tc-99m Mebrofenin Kit · by Bracco
Key facts
- Active ingredient
- Technetium Tc-99m Mebrofenin Kit
- Form
- Injectable
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Bracco
- FDA application
- NDA018963
What is Choletec?
From the FDA label:Each reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF 2 •2H 2 O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF 2 •2H 2 O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. The structure of mebrofenin (2,2’-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below: When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection. Choletec-struct
How to use
The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is: Nonjaundiced patient: 74-185 MBq (2-5 mCi) Patient with serum bilirubin level greater than 1.5 mg/dL: 111-370 MBq (3-10 mCi) The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. The patient should be in a fasting state, 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food. An interval of at least 24 hours should be allowed before repeat examination. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Side effects
Urticaria and rash have been rarely reported with the use of Technetium Tc 99m Mebrofenin since market introduction. Rare cases of chills and nausea have been reported with related compounds. Infrequently, death has been reported in association with the use of this class of agents.
Warnings
Important safety information
The theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.
Who should not take Choletec
Hypersensitivity to this compound.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- Is there a coupon or discount for Choletec?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Choletec. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Choletec?
- Choletec is marketed by Bracco. You can see Bracco's full profile, rating, and other products on pharmaranks.
- Is Choletec a brand-name or generic drug?
- Choletec is a brand-name product with the active ingredient Technetium Tc-99m Mebrofenin Kit.
- Is Choletec available over the counter?
- No. Choletec is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Choletec come in?
- Choletec is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Choletec FDA-registered?
- Choletec is on record with the U.S. FDA under application number NDA018963. You can verify this on its official FDA label.
- Is Choletec safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Choletec. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Choletec?
- Choletec's side effects are taken directly from its FDA label. From the label: Urticaria and rash have been rarely reported with the use of Technetium Tc 99m Mebrofenin since market introduction. Rare cases of chills and nausea have been reported with related compounds. Infrequently, death has been reported in association with the use of this class of agents. Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about TECHNETIUM TC-99M MEBROFENIN KIT
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 12 reports naming TECHNETIUM TC-99M MEBROFENIN KIT — the active ingredient in Choletec, and the FDA flagged 33% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- dizziness3 reports
- urticaria3 reports
- balance disorder2 reports
- confusional state2 reports
- coordination abnormal2 reports
- disorientation2 reports
- disturbance in attention2 reports
- erythema2 reports
Read these as a signal, not a rate. A report does not mean TECHNETIUM TC-99M MEBROFENIN KIT caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 26, 2026.
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