"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
- Clinician Information:
Ca-DTPA Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ca-DTPA FDA Prescribing Information: Side Effects
In the U.S. Registry, a total of 646 individuals received at least one dose of either Ca-DTPA (pentetate calcium trisodium inj) or Zn-DTPA. Of these, 632 received Ca-DTPA (pentetate calcium trisodium inj) by one or more routes of administration. Three hundred and twenty-six individuals were dosed by inhalation, 293 by intravenous injection, and 60 by other or unknown routes of administration.
Of the individuals that received Ca-DTPA (pentetate calcium trisodium inj) , 393/632 (62%) received one dose and 65 (10%) received two doses. The remaining 174 individuals received three or more doses. The largest number of Ca-DTPA (pentetate calcium trisodium inj) doses to a single individual was 338 delivered over 6.5 years. Overall, the presence or absence of adverse events was recorded in 310/646 individuals. Of these 19 (6.1%) individuals reported at least one adverse event. The total number of recorded adverse events was 20. Of the 20 adverse events, 18 adverse events occurred after treatment with Ca-DTPA (pentetate calcium trisodium inj) . Adverse events included headache, lightheadedness, chest pain, allergic reaction, dermatitis, metallic taste, nausea and diarrhea, and injection site reactions.
Read the entire FDA prescribing information for Ca-DTPA (Pentetate Calcium Trisodium Inj) »
Additional Ca-DTPA Information
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