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)
Toxic optic neuropathy06.02.08.003; 12.03.01.033; 17.04.05.0090.002863%-
Concomitant disease progression08.01.03.064---
Terminal state08.01.03.079---
Bone fistula15.02.04.0270.015746%-
Palatal disorder07.05.01.019---
Bone swelling15.02.01.0060.007157%-
Pachymeningitis17.06.03.0040.010020%-
Breast cancer metastatic16.10.01.008; 21.05.01.0160.010593%-
Biliary dilatation09.02.03.0040.004294%-
Ovarian cancer metastatic16.12.04.004; 21.11.01.013---
Neurogenic shock17.02.10.025; 24.06.02.023---
Parophthalmia06.04.11.0030.039795%-
Paraneoplastic syndrome16.32.01.009---
Communication disorder19.19.01.008---
Foot deformity15.10.03.005---
Corneal endotheliitis06.04.02.0110.012883%-
Hypercreatininaemia14.11.01.039; 20.01.02.0160.004294%-
Low turnover osteopathy14.04.04.015; 15.02.03.016; 20.01.01.0100.002863%-
Single functional kidney20.01.02.019---
Oroantral fistula07.11.05.015; 22.04.06.0050.024907%-
Oral cavity fistula07.11.05.0140.038649%
Intracardiac mass02.11.01.016; 24.01.05.0100.004294%-
Stress cardiomyopathy02.04.01.012; 24.04.04.0260.007157%-
Weight bearing difficulty15.03.05.0340.009161%-
Fistula discharge08.01.03.069; 15.03.02.0150.015746%-
Exposed bone in jaw15.02.04.0340.165190%-
Hyporesponsive to stimuli17.02.05.0570.010020%-
Spinal pain08.01.08.030; 15.02.01.008; 17.10.01.0200.012024%-
Autoinflammatory disease08.05.02.012; 10.02.07.0010.007157%-
Invasive ductal breast carcinoma16.10.01.013; 21.05.01.021---
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