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)
Sinus disorder22.04.06.0020.008589%
Non-cardiac chest pain22.12.02.009; 08.01.08.006--
Arterial occlusive disease24.04.02.021--Not Available
Bowel movement irregularity07.02.03.0030.010593%Not Available
Erosive oesophagitis07.04.05.0040.002863%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.008589%Not Available
Vessel puncture site bruise24.07.06.016; 12.07.04.009; 23.03.11.014; 08.02.04.009--Not Available
Choroidal effusion06.09.01.0080.002863%Not Available
Oral mucosa erosion07.05.06.0090.002863%Not Available
Osteonecrosis of jaw15.02.04.010; 24.04.05.0051.327249%
Infusion site extravasation12.07.05.008; 08.02.05.0070.087033%
Chronic kidney disease20.01.03.0170.008589%
Infusion site haemorrhage24.07.01.058; 12.07.05.018; 08.02.05.018--Not Available
Loose tooth07.09.05.0090.022044%Not Available
Bone loss15.02.04.0200.012883%Not Available
Tendon pain15.07.01.0090.002863%Not Available
Gingival erythema07.09.13.0060.002863%Not Available
Adverse reaction08.06.01.0180.002863%Not Available
Oral disorder07.05.01.0050.012024%Not Available
Skin mass23.07.04.014--Not Available
Renal cell carcinoma20.01.04.003; 16.08.02.002--Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.0080.002863%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Acute kidney injury20.01.03.0160.122247%
Bone marrow reticulin fibrosis16.32.03.010; 01.05.01.0090.004294%Not Available
Atypical femur fracture15.08.03.019; 12.04.01.019--Not Available
Functional gastrointestinal disorder07.11.01.0160.005726%Not Available
Hepatic cancer09.04.02.008; 16.07.02.004--Not Available
Candida infection11.03.03.021--
Noninfective gingivitis07.09.13.0160.002863%Not Available
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