Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Zoledronic acid
Drug ID BADD_D02392
Description Zoledronic acid, or CGP 42'446,[A203120] is a third generation, nitrogen containing bisphosphonate similar to [ibandronic acid], [minodronic acid], and [risedronic acid].[A203111] Zoledronic acid is used to treat and prevent multiple forms of osteoporosis, hypercalcemia of malignancy, multiple myeloma, bone metastases from solid tumors, and Paget’s disease of bone.[L13712,L13715,L13721] Zoledronic acid was first described in the literature in 1994.[A203120] Zoledronic acid was granted FDA approval on 20 August 2001.[L13712]
Indications and Usage Zoledronic acid is indicated to treat hypercalcemia of malignancy, multiple myeloma, bone metastases from solid tumors, osteoporosis in men and postmenopausal women, glucocorticoid induced osteoporosis, and Paget's disease of bone in men and women.[L13712,L13715,L13721] Zoledronic acid is also indicated for the prevention of osteoporosis in post menopausal women and glucocorticoid induced osteoporosis.[L13712,L13715,L13721]
Marketing Status approved
ATC Code M05BA08
DrugBank ID DB00399
KEGG ID D01968; D08689
MeSH ID D000077211
PubChem ID 68740
TTD Drug ID D0VM2L
NDC Product Code 63415-0532; 0078-0435; 25021-826; 55150-266; 67457-619; 68083-142; 14593-836; 63850-7104; 82920-012; 63323-966; 69367-190; 65372-1117; 17478-327; 71288-806; 62147-0125; 68554-0037; 16729-242; 43598-330; 55150-283; 67457-794; 68001-437; 65129-1144; 0143-9642; 63323-961; 68083-116; 68083-135; 0409-4215; 16714-815; 67457-390; 68083-256; 63126-906; 43598-331; 70860-210; 72266-152; 42533-102; 53104-7622; 65797-0006; 43598-255; 25021-801; 54288-100; 57741-2600; 25021-830; 55111-685; 55111-688
UNII 6XC1PAD3KF
Synonyms Zoledronic Acid | 2-(Imidazol-1-yl)-1-hydroxyethylidene-1,1-bisphosphonic acid | CGP 42446A | CGP-42446 | CGP 42446 | CGP42446 | CGP-42'446 | CGP42'446 | CGP 42'446 | Zometa | Zoledronic Acid Anhydrous | Zoledronate
Chemical Information
Molecular Formula C5H10N2O7P2
CAS Registry Number 118072-93-8
SMILES C1=CN(C=N1)CC(O)(P(=O)(O)O)P(=O)(O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Fanconi syndrome acquired20.05.03.012; 14.01.01.0130.008589%Not Available
Musculoskeletal stiffness15.03.05.0270.057258%Not Available
Protein urine present13.13.02.006--Not Available
Musculoskeletal discomfort15.03.04.0010.013456%Not Available
Injection site swelling12.07.03.018; 08.02.03.0170.016032%Not Available
Secretion discharge08.01.03.0190.006298%Not Available
Infusion site pain12.07.05.002; 08.02.05.0140.011165%Not Available
Infusion site swelling08.02.05.002; 12.07.05.003--Not Available
Extraocular muscle disorder15.05.05.004; 06.05.02.0050.005726%Not Available
Vascular rupture24.03.02.023; 12.01.11.006--Not Available
Limb deformity15.10.03.004--Not Available
Acquired haemophilia01.01.01.0020.005726%Not Available
Infusion site oedema12.07.05.013; 08.02.05.012--Not Available
Nodule08.03.05.0020.012597%Not Available
Dental discomfort07.09.06.0020.009161%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.014028%Not Available
Cerebral disorder17.02.10.0170.006298%Not Available
Infusion site reaction12.07.05.006; 08.02.05.0050.009734%Not Available
Hypertensive nephropathy24.08.05.003; 20.01.08.0040.004294%Not Available
Fluid intake reduced14.05.10.001--Not Available
Pulmonary mass22.02.07.0040.007157%Not Available
Temperature intolerance08.01.09.0220.002863%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.005726%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.004294%Not Available
Chronic inflammatory demyelinating polyradiculoneuropathy17.09.04.004; 10.04.10.0040.005726%Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
Ocular icterus09.01.01.007; 06.08.03.009; 01.06.04.007--Not Available
Dysgraphia17.02.03.006--Not Available
Hypogonadism21.03.02.010; 05.05.04.002--Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.010020%Not Available
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