What the label lists and what reports show
Pamidronate side effects
Pamidronate's FDA label: “Drug-related local soft-tissue symptoms (redness, swelling or induration and pain on palpation) at the site of catheter insertion were most common in patients treated with 90 mg of pamidronate disodium.” FAERS holds 3,386 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is osteonecrosis (533 reports).
- Generic listed
Check it at the source: the pamidronate FDA label on DailyMed (effective May 14, 2026, Hospira, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsDrug-related local soft-tissue symptoms (redness, swelling or induration and pain on palpation) at the site of catheter insertion were most common in patients treated with 90 mg of pamidronate disodium.
Commonly Reported Adverse Experiences in Three U.S. Controlled Clinical Trials
| General | Pamidronate Disodium 90 mg over 4 hours N=205 % | Placebo N=187 % | Pamidronate Disodium 90 mg over 2 hours N=367 % | Placebo N=386 % | All Pamidronate Disodium 90 mg N=572 % | Placebo N=573 % |
|---|---|---|---|---|---|---|
| Asthenia | 16.1 | 17.1 | 25.6 | 19.2 | 22.2 | 18.5 |
| Fatigue | 31.7 | 28.3 | 40.3 | 28.8 | 37.2 | 29.0 |
| Fever | 38.5 | 38 | 38.1 | 32.1 | 38.5 | 34 |
| Metastases | 1.0 | 3.0 | 31.3 | 24.4 | 20.5 | 17.5 |
| Pain | 13.2 | 11.8 | 15.0 | 18.1 | 14.3 | 16.1 |
| Anorexia | 17.1 | 17.1 | 31.1 | 24.9 | 26.0 | 22.3 |
| Constipation | 28.3 | 31.7 | 36.0 | 38.6 | 33.2 | 35.1 |
| Diarrhea | 26.8 | 26.8 | 29.4 | 30.6 | 28.5 | 29.7 |
| Dyspepsia | 17.6 | 13.4 | 18.3 | 15.0 | 22.6 | 17.5 |
| Nausea | 35.6 | 37.4 | 63.5 | 59.1 | 53.5 | 51.8 |
| Pain abdominal | 19.5 | 16.0 | 24.3 | 18.1 | 22.6 | 17.5 |
| Vomiting | 16.6 | 19.8 | 46.3 | 39.1 | 35.7 | 32.8 |
| Anemia | 47.8 | 41.7 | 39.5 | 36.8 | 42.5 | 38.4 |
| Granulocytopenia | 20.5 | 15.5 | 19.3 | 20.5 | 19.8 | 18.8 |
| Thrombocytopenia | 16.6 | 17.1 | 12.5 | 14.0 | 14.0 | 15.0 |
| Arthralgias | 10.7 | 7.0 | 15.3 | 12.7 | 13.6 | 10.8 |
| Myalgia | 25.4 | 15.0 | 26.4 | 22.5 | 26 | 20.1 |
| Skeletal Pain | 61.0 | 71.7 | 70.0 | 75.4 | 66.8 | 74 |
| Anxiety | 7.8 | 9.1 | 18.0 | 16.8 | 14.3 | 14.3 |
| Headache | 24.4 | 19.8 | 27.2 | 23.6 | 26.2 | 22.3 |
| Insomnia | 17.1 | 17.2 | 25.1 | 19.4 | 22.2 | 19.0 |
| Coughing | 26.3 | 22.5 | 25.3 | 19.7 | 25.7 | 20.6 |
| Dyspnea | 22.0 | 21.4 | 35.1 | 24.4 | 30.4 | 23.4 |
| Pleural effusion | 2.9 | 4.3 | 15.0 | 9.1 | 10.7 | 7.5 |
| Sinusitis | 14.6 | 16.6 | 16.1 | 10.4 | 15.6 | 12.0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Studies Hypercalcemia of Malignancy Transient mild elevation of temperature by at least 1°C was noted 24 to 48 hours after administration of pamidronate disodium in 34% of patients in clinical trials. In the saline trial, 18% of patients had a temperature elevation of at least 1°C 24 to 48 hours after treatment. Drug-related local soft-tissue symptoms (redness, swelling or induration and pain on palpation) at the site of catheter insertion were most common in patients treated with 90 mg of pamidronate disodium. Symptomatic treatment resulted in rapid resolution in all patients. Rare cases of uveitis, iritis, scleritis, and episcleritis have been reported, including one case of scleritis, and one case of uveitis upon separate rechallenges. Five of 231 patients (2%) who received pamidronate disodium during the four U.S. controlled hypercalcemia clinical studies were reported to have had seizures, 2 of whom had preexisting seizure disorders. None of the seizures were considered to be drug-related by the investigators. …
Source: FDA drug label, Hospira, Inc., effective May 14, 2026 (SPL set 9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,386 reports list pamidronate among the medicines taken, 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. Of the 22 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pamidronate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions