Prescription medicine
Pamidronate First approved as Aredia
Pamidronate (Aredia) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the pamidronate FDA label on DailyMed (effective May 14, 2026, Hospira, Inc.); the NDA 20036 record on Drugs@FDA; every pamidronate label on DailyMed.
Highlights of the record
FDA label of May 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageHypercalcemia of Malignancy Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.
Forms and strengths
- 3 mg/ml
- 6 mg/ml
- 9 mg/ml
Injection (solution); injection.
On the market
- Earliest approval on file
- October 31, 1991 Aredia, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first April 30, 2001; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,386 through July 30, 2026
What is pamidronate used for?
From the label: indications and usageHypercalcemia of Malignancy Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). […]
FDA pharmacologic class: Bisphosphonate.
Source: FDA drug label (Pamidronate Disodium), Hospira, Inc., effective May 14, 2026 (SPL set 9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23), via openFDA; the full label on DailyMed
Is there a generic for pamidronate (Aredia)?
The FDA approved the first generic pamidronate on April 30, 2001. 13 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists pamidronate from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 earliest approval on file
- 2001 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for pamidronate?
The FDA Adverse Event Reporting System holds 3,386 reports that list pamidronate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 428 are coded as a death and 1,053 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other bisphosphonates
- the pharmacologic class, with prices and generics
- Pamidronate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other