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)
Seasonal allergy06.04.01.013; 22.04.04.008; 10.01.04.001--Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.085315%Not Available
Brain oedema17.07.02.003; 12.01.10.010--
Acute phase reaction08.01.05.0040.066706%Not Available
Autoimmune thyroiditis10.04.08.006; 05.02.04.002--Not Available
Osteopenia15.02.03.003; 14.04.04.0040.041226%Not Available
Gingival ulceration07.09.13.0140.002863%Not Available
Sudden cardiac death08.04.01.008; 02.03.04.0160.002863%Not Available
General physical health deterioration08.01.03.018--Not Available
Bone density decreased13.16.01.001--Not Available
Tongue dry07.14.02.009--Not Available
Balance disorder08.01.03.081; 17.02.02.0070.025480%Not Available
Lung cancer metastatic22.08.01.004; 16.19.02.003--Not Available
Dysstasia08.01.03.089; 17.02.02.012; 15.03.05.0110.021186%Not Available
Intervertebral disc protrusion15.10.01.004--Not Available
Morbid thoughts19.10.03.004--Not Available
Skin tightness23.03.03.0180.007157%Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.029488%
Hyperphosphaturia20.02.01.025; 14.04.03.0060.004294%Not Available
Hyperuricosuria20.02.01.0190.004294%Not Available
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.005726%Not Available
Malignant neoplasm progression16.16.01.0050.040653%Not Available
Large intestine polyp16.05.02.006; 07.20.01.0100.004294%Not Available
Conjunctival hyperaemia06.04.01.0040.004294%Not Available
Infusion related reaction12.02.05.009; 08.01.03.002; 10.01.01.017--
Cytokine release syndrome10.02.01.0100.004294%
Ear discomfort04.03.01.0050.009734%Not Available
Respiratory tract congestion22.02.07.003--Not Available
Lymphatic disorder01.09.01.003--Not Available
Deafness bilateral04.02.01.0070.008589%Not Available
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