Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Alendronic acid
Drug ID BADD_D00066
Description Alendronic acid is a second generation bisphosphonate that is used for the treatment of some forms of osteoperosis and Paget's disease[FDA Label][A959,A203111]. It functions by preventing resorption of bone[FDA Label][A959].
Indications and Usage Alendronic acid is indicated for the treatment and prevention of osteoporosis in men and postmenopausal women, treatment of glucocorticoid-induced osteoporosis, and Paget's disease of bone[FDA Label][A959,A176750]. However, alendronic acid is not indicated for use in pediatric populations or patients with a creatinine clearance <35mL/min[FDA Label].
Marketing Status approved
ATC Code M05BA04
DrugBank ID DB00630
KEGG ID D07119
MeSH ID D019386
PubChem ID 2088
TTD Drug ID D09KLR
NDC Product Code Not Available
UNII X1J18R4W8P
Synonyms Alendronate | 4-Amino-1-Hydroxybutylidene 1,1-Biphosphonate | Aminohydroxybutane Bisphosphonate | MK-217 | MK 217 | MK217 | Alendronate Monosodium Salt, Trihydrate | Alendronate Sodium | Fosamax
Chemical Information
Molecular Formula C4H13NO7P2
CAS Registry Number 66376-36-1
SMILES C(CC(O)(P(=O)(O)O)P(=O)(O)O)CN
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)
Treatment failure08.06.01.0170.000484%-
Regurgitation07.01.07.004---
Pharyngeal disorder22.04.05.0070.000044%-
Organising pneumonia22.01.02.0080.000066%-
Adverse reaction08.06.01.0180.000097%-
Type 1 diabetes mellitus05.06.01.010; 10.04.08.007; 14.06.01.0100.000066%-
Type 2 diabetes mellitus05.06.01.003; 14.06.01.0030.001057%-
Oral disorder07.05.01.0050.000638%-
Focal segmental glomerulosclerosis20.05.01.0030.000044%-
Skin mass23.07.04.0140.000044%-
Mucosal atrophy08.01.06.0190.000066%-
Occipital neuralgia17.14.01.0130.000044%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.000361%
Vulvovaginal pain21.08.02.0090.000044%
Acute kidney injury20.01.03.0160.000881%
Upper-airway cough syndrome22.12.03.0360.000220%
Oesophageal irritation07.08.05.0040.000044%-
Gastrointestinal tract irritation07.08.03.008---
Macular pigmentation06.09.03.0150.000044%-
Functional gastrointestinal disorder07.11.01.0160.000154%-
Macular fibrosis06.09.03.0140.000044%-
Atypical fracture12.04.02.011; 15.08.02.009---
Intraductal proliferative breast lesion16.10.01.006; 21.05.01.0140.000132%-
Peripheral venous disease24.04.02.0220.000616%-
Mouth swelling07.05.04.007; 10.01.05.020; 23.04.01.0200.000198%-
Noninfective sialoadenitis07.06.04.0030.000044%-
Neuropathic muscular atrophy15.05.03.029; 17.05.03.0130.000044%-
Sinus node dysfunction02.03.03.0170.000154%
Spinal cord haematoma12.01.13.005; 17.08.01.037; 24.07.04.0190.000044%-
Complication associated with device08.07.01.0110.000330%-
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