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%Not Available
Regurgitation07.01.07.004--Not Available
Pharyngeal disorder22.04.05.0070.000044%Not Available
Organising pneumonia22.01.02.0080.000066%Not Available
Adverse reaction08.06.01.0180.000097%Not Available
Type 1 diabetes mellitus14.06.01.010; 10.04.08.007; 05.06.01.0100.000066%Not Available
Type 2 diabetes mellitus14.06.01.003; 05.06.01.0030.001057%Not Available
Oral disorder07.05.01.0050.000638%Not Available
Focal segmental glomerulosclerosis20.05.01.0030.000044%Not Available
Skin mass23.07.04.0140.000044%Not Available
Mucosal atrophy08.01.06.0190.000066%Not Available
Occipital neuralgia17.14.01.0130.000044%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000361%
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%Not Available
Gastrointestinal tract irritation07.08.03.008--Not Available
Macular pigmentation06.09.03.0150.000044%Not Available
Functional gastrointestinal disorder07.11.01.0160.000154%Not Available
Macular fibrosis06.09.03.0140.000044%Not Available
Atypical fracture15.08.02.009; 12.04.02.011--Not Available
Intraductal proliferative breast lesion16.10.01.006; 21.05.01.0140.000132%Not Available
Peripheral venous disease24.04.02.0220.000616%Not Available
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.0070.000198%Not Available
Noninfective sialoadenitis07.06.04.0030.000044%Not Available
Neuropathic muscular atrophy17.05.03.013; 15.05.03.0290.000044%Not Available
Sinus node dysfunction02.03.03.0170.000154%
Spinal cord haematoma24.07.04.019; 17.08.01.037; 12.01.13.0050.000044%Not Available
Complication associated with device08.07.01.0110.000330%Not Available
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