Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ibandronic acid
Drug ID BADD_D01117
Description Ibandronate, or BM 21.0955, is a third generation, nitrogen containing bisphosphonate similar to [zoledronic acid], [minodronic acid], and [risedronic acid].[A203111,A203138] It is used to prevent and treat postmenopausal osteoporosis.[L13805,L13808] Ibandronate was first described in the literature in 1993 as a treatment for bone loss in dogs.[A203138] Ibandronate was granted FDA approval on 16 May 2003.[L13805]
Indications and Usage For the treatment and prevention of osteoporosis in postmenopausal women.[L13805,L13808]
Marketing Status approved; investigational
ATC Code M05BA06
DrugBank ID DB00710
KEGG ID D08056
MeSH ID D000077557
PubChem ID 60852
TTD Drug ID D08SJZ
NDC Product Code Not Available
UNII UMD7G2653W
Synonyms Ibandronic Acid | Ibandronate | 1-Hydroxy-3-(methylpentylamino)propylidenebisphosphonate | (1-Hydroxy-3-(methylpentylamino)propylidene)bisphosphonate | Ibandronate Sodium Anhydrous | Boniva | Bonviva | Ibandronate Sodium | Ibandronic Acid, Sodium Salt, Monohydrate | RPR 102289A | RPR-102289A | RPR102289A | Bondronat | BM 21.0955 | BM 210955 | BM-21.0955 | BM21.0955 | BM-210955 | BM210955
Chemical Information
Molecular Formula C9H23NO7P2
CAS Registry Number 114084-78-5
SMILES CCCCCN(C)CCC(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)
Injection site pain12.07.03.011; 08.02.03.0100.020621%Not Available
Injection site phlebitis12.07.03.012; 24.12.03.003; 08.02.03.0110.000697%Not Available
Injection site reaction12.07.03.015; 08.02.03.0140.014159%
Injection site vesicles23.03.01.024; 12.07.03.051; 08.02.03.0510.001615%Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Iritis10.02.01.022; 06.04.03.002--Not Available
Joint swelling15.01.02.0040.003389%Not Available
Lip swelling10.01.05.005; 07.05.04.005; 23.04.01.0070.000855%Not Available
Local reaction08.01.03.012--Not Available
Macular degeneration06.09.03.0010.001077%Not Available
Malaise08.01.01.003--
Mass08.03.05.0030.001615%Not Available
Melaena07.12.02.004; 24.07.02.0130.000317%Not Available
Migraine24.03.05.003; 17.14.02.0010.002154%Not Available
Mouth ulceration07.05.06.0040.001077%Not Available
Movement disorder17.01.02.0100.001235%Not Available
Multiple fractures15.08.02.005; 12.04.02.009--Not Available
Muscle disorder15.05.03.0140.000697%Not Available
Muscle spasms15.05.03.0040.010928%
Musculoskeletal pain15.03.04.0070.012639%
Myalgia15.05.02.0010.031422%
Myocardial ischaemia24.04.04.010; 02.02.02.008--Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neck pain15.03.04.0090.004466%
Necrosis24.04.02.006; 08.03.03.0010.000855%Not Available
Nephrolithiasis20.04.01.0020.002154%
Nephropathy toxic20.05.03.002; 12.03.01.0100.000475%Not Available
Nervous system disorder17.02.10.001--Not Available
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