Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Strontium ranelate
Drug ID BADD_D02076
Description Strontium ranelate, a strontium (II) salt of ranelic acid, is a medication for osteoporosis. Some reports have shown that strontium ranelate can slow down the progression of osteoarthritis of the knee. This agent presents an atypical mechanism of action in which it increases deposition of new bone by osteoblasts and, simultaneously, reduces the resorption of bone by osteoclasts. It is therefore promoted as a "dual action bone agent" (DABA) indicated for use in treatment of severe osteoporosis. Furthermore, various clinical studies demonstrate the ability of strontium ranelate to improve and strengthen intrinsic bone tissue quality and microarchitecture in osteoporosis by way of a number of cellular and microstructural changes by which anti-fracture efficacy is enhanced. Available for prescription use for a time in some parts of the world as Protelos (strontium ranelate) 2 g granules for oral suspension by Servier, it was ultimately discontinued in 2016-2017 owing to an increased adverse cardiac effects profile along with increased risk of venous thromboembolism (VTE) and various life threatening allergic reactions.
Indications and Usage Strontium ranelate is therapeutically indicated for the treatment of severe osteoperosis in: a) postmenopasual women, and b) adult men, who are at high risk of fractures, for whom treatment with other medical products approved for the treatment of osteoperosis is not possible due to, for example, contraindications or intolerance. [L1127] In postmenopausal women, strontium ranelate can also reduce the risk of vertebral and hip fractures [L1127].
Marketing Status approved; withdrawn
ATC Code M05BX03
DrugBank ID DB09267
KEGG ID D08468
MeSH ID C081587
PubChem ID 6918182
TTD Drug ID D0X7KZ
NDC Product Code Not Available
UNII 04NQ160FRU
Synonyms strontium ranelate | protelos | S12911-5 | S12911-0 | S12911-2 | 3-(3-cyano-4-carboxymethyl-5-carboxy-2-thienyl)-3-azapentanedioic distrontium salt | S 12911 | S12911 | S-12911
Chemical Information
Molecular Formula C12H6N2O8SSr2
CAS Registry Number 135459-87-9
SMILES C(C1=C(SC(=C1C#N)N(CC(=O)[O-])CC(=O)[O-])C(=O)[O-])C(=O)[O-].[Sr+2].[Sr+2]
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)
Lymphadenopathy01.09.01.002--Not Available
Malaise08.01.01.003--
Menopause26.03.01.001--Not Available
Mouth ulceration07.05.06.004--Not Available
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Myocardial infarction02.02.02.007; 24.04.04.009--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pancytopenia01.03.03.003--Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Seizure17.12.03.001--
Skin disorder23.03.03.007--Not Available
Stevens-Johnson syndrome11.07.01.005; 10.01.01.045; 23.03.01.007; 12.03.01.014--
Stomatitis07.05.06.005--
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Urticaria23.04.02.001; 10.01.06.001--
Vertigo17.02.12.002; 04.04.01.003--
Vomiting07.01.07.003--
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Lymphatic disorder01.09.01.003--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Transaminases increased13.03.04.036--Not Available
Angiopathy24.03.02.007--Not Available
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