Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Alendronate sodium
Drug ID BADD_D00065
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 Not Available
DrugBank ID DB00630
KEGG ID D00939
MeSH ID D019386
PubChem ID 6331783
TTD Drug ID D09KLR
NDC Product Code 55111-874; 65862-327; 16714-633; 50090-5677; 65862-268; 0115-1678; 50090-5474; 64980-342; 65862-328; 65862-329; 78206-135; 50090-2322; 64980-340; 60723-205; 63415-0071; 0115-1679; 70954-264; 65691-0056; 0115-1680; 61919-689; 53104-7525; 70518-0033; 16714-631; 17139-400; 0115-1676; 50090-4692; 0054-0282; 13371-111; 60723-207; 16714-632; 0115-1681; 68788-8235; 69097-223; 69097-224; 69543-130; 71205-048; 65372-1134; 61919-729; 64980-341; 67296-1500; 68788-7130; 69543-131; 12658-0568; 50090-3126
UNII 2UY4M2U3RA
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 C4H13NNaO7P2
CAS Registry Number 129318-43-0
SMILES C(CC(O)(P(=O)(O)O)P(=O)(O)O)CN.[Na]
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)
Melaena24.07.02.013; 07.12.02.004--Not Available
Mouth ulceration07.05.06.004--Not Available
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Oesophageal stenosis07.13.02.001--
Oesophageal ulcer07.04.05.002--
Oesophagitis07.08.05.001--
Osteonecrosis24.04.05.004; 15.02.04.007--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Scleritis06.04.07.002; 10.02.01.025--Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Toxic epidermal necrolysis12.03.01.015; 11.07.01.006; 10.01.01.006; 23.03.01.008--
Urticaria23.04.02.001; 10.01.06.001--
Uveitis10.02.01.023; 06.04.03.003--
Vertigo17.02.12.002; 04.04.01.003--
Vomiting07.01.07.003--
Adverse event08.06.01.010--Not Available
Erosive oesophagitis07.04.05.004--Not Available
Osteonecrosis of jaw24.04.05.005; 15.02.04.010--
Regurgitation07.01.07.004--Not Available
Perforation08.01.03.058--Not Available
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