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)
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.0070.002863%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.017178%
Anal incontinence17.05.01.021; 07.01.06.0290.013456%
Biliary cirrhosis09.01.04.006--Not Available
Blood blister23.03.01.028; 12.01.06.013--Not Available
Bone cancer16.29.02.002; 15.09.03.012--Not Available
Breast cancer recurrent16.10.01.009; 21.05.01.017--Not Available
Breast cancer stage I16.10.01.010; 21.05.01.018--Not Available
Cardiac failure chronic02.05.01.009--Not Available
Cervical spinal stenosis15.10.04.006; 17.10.02.006--Not Available
Coeliac disease14.02.01.007; 10.04.04.012; 07.17.01.008--Not Available
Concomitant disease aggravated08.01.03.063--Not Available
Enamel anomaly07.09.02.003--Not Available
Exostosis of jaw15.02.04.0330.012597%Not Available
Fracture nonunion15.08.01.004; 12.04.02.0170.002863%Not Available
IgA nephropathy20.05.01.016; 10.02.01.0630.004294%Not Available
Jaw cyst16.11.03.002; 15.02.04.0350.005726%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.004294%Not Available
Lung carcinoma cell type unspecified recurrent22.08.01.018; 16.19.02.005--Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.023476%Not Available
Metastases to kidney20.01.04.010; 16.22.02.017--Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.002863%Not Available
Metastases to skin23.07.04.026; 16.22.02.0230.002863%Not Available
Osteitis deformans15.02.04.013--Not Available
Progressive supranuclear palsy17.03.01.002--Not Available
Pulmonary sarcoidosis22.01.01.023; 10.02.06.0030.004294%Not Available
Recurrent cancer16.16.01.015--Not Available
Sleep disorder due to general medical condition, insomnia type19.02.04.004--Not Available
Systemic mastocytosis16.21.01.008; 01.13.01.008; 10.02.01.0140.005726%Not Available
Throat cancer22.08.02.008; 16.19.02.007--Not Available
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