What the label lists and what reports show
Zoledronic acid side effects
Zoledronic acid's FDA label: “The most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea.” FAERS holds 39,910 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 arthralgia (3,219 reports).
- Generic listed
Check it at the source: the zoledronic acid FDA label on DailyMed (effective November 15, 2023, Gland Pharma Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Reclast?Reclast may cause serious side effects. • See “What is the most important information I should know about Reclast?” The most common side effects of Reclast included: • Fever • Pain in your bones, joints or muscles • Pain in your arms and legs • Headache • Flu-like illness (fever, chills, bone, joint, or muscle pain, fatigue) • Nausea • Vomiting • Diarrhea Talk to your doctor about things you can do to help decrease some of these side effects that might happen with a Reclast infusion. You may get allergic reactions, such as hives, swelling of your face, lips, tongue, or throat. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Reclast. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label (Reclast), Sandoz Inc, effective February 3, 2026 (SPL set 5a9b3737-9ce6-4a89-b76e-6aab79eba9cf), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea.
Table 1. Adverse Reactions Occurring in Greater Than or Equal to 2.0% of Patients with Osteoporosis and More Frequently Than in Placebo-Treated Patients
This table is printed in the Reclast label published by Sandoz Inc of February 3, 2026; the label quoted above does not print one.
| System Organ Class | 5 mg IV Reclast once per year % (N = 3862) | Placebo once per year % (N = 3852) | 5 mg IV Reclast once per year % (N = 1054) | Placebo once per year % (N = 1057) |
|---|---|---|---|---|
| Anemia | 4.4 | 3.6 | 5.3 | 5.2 |
| Dehydration | 0.6 | 0.6 | 2.5 | 2.3 |
| Anorexia | 2.0 | 1.1 | 1.0 | 1.0 |
| Headache | 12.4 | 8.1 | 3.9 | 2.5 |
| Dizziness | 7.6 | 6.7 | 2.0 | 4.0 |
| Vertigo | 4.3 | 4.0 | 1.3 | 1.7 |
| Atrial fibrillation | 2.4 | 1.9 | 2.8 | 2.6 |
| Hypertension | 12.7 | 12.4 | 6.8 | 5.4 |
| Nausea | 8.5 | 5.2 | 4.5 | 4.5 |
| Diarrhea | 6.0 | 5.6 | 5.2 | 4.7 |
| Vomiting | 4.6 | 3.2 | 3.4 | 3.4 |
| Abdominal pain upper | 4.6 | 3.1 | 0.9 | 1.5 |
| Dyspepsia | 4.3 | 4.0 | 1.7 | 1.6 |
| Arthralgia | 23.8 | 20.4 | 17.9 | 18.3 |
| Myalgia | 11.7 | 3.7 | 4.9 | 2.7 |
| Pain in extremity | 11.3 | 9.9 | 5.9 | 4.8 |
| Shoulder pain | 6.9 | 5.6 | 0.0 | 0.0 |
| Bone pain | 5.8 | 2.3 | 3.2 | 1.0 |
| Neck pain | 4.4 | 3.8 | 1.4 | 1.1 |
| Muscle spasms | 3.7 | 3.4 | 1.5 | 1.7 |
| Osteoarthritis | 9.1 | 9.7 | 5.7 | 4.5 |
| Musculoskeletal pain | 0.4 | 0.3 | 3.1 | 1.2 |
| Pyrexia | 17.9 | 4.6 | 8.7 | 3.1 |
| Influenza-like illness | 8.8 | 2.7 | 0.8 | 0.4 |
| Fatigue | 5.4 | 3.5 | 2.1 | 1.2 |
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, continuedThe most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 864-879-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because 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. Hypercalcemia of Malignancy The safety of Zoledronic Acid Injection was studied in 185 patients with hypercalcemia of malignancy (HCM) who received either Zoledronic Acid Injection 4 mg given as a 5-minute intravenous infusion (n=86) or pamidronate 90 mg given as a 2-hour intravenous infusion (n=103). The population was aged 33 to 84 years, 60% male and 81% Caucasian, with breast, lung, head and neck, and renal cancer as the most common forms of malignancy. NOTE: pamidronate 90 mg was given as a 2-hour intravenous infusion. The relative safety of pamidronate 90 mg given as a 2-hour intravenous infusion compared to the same dose given as a 24-hour intravenous infusion has not been adequately studied in controlled clinical trials. …
Source: FDA drug label, Gland Pharma Limited, effective November 15, 2023 (SPL set 7a5e8962-7c4b-40bb-ad69-0c3edb0338af), via openFDA; the full label on DailyMed
What do FAERS reports show?
39,910 reports list zoledronic acid among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,134 are coded as a death and 11,505 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, 18 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?
- Zoledronic acid: 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