Strontium: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: February 20, 2026🚩 Report this page

Strontium

Active ingredient

GB MHRAUS FDA

Drug class: -
Availability: Over-the-counter
Routes: Oral
Markets covered: 2
Products on record: 3

Overview

Strontium is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	February 20, 2026
US United States	FDA	2	September 28, 2023

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised February 20, 2026[1]

Treatment of severe osteoporosis - in postmenopausal women; - in adult men at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
1). 4).

How to take

USUnited States· FDA

2 products

2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [2].

Sources & citations

[1]MHRA (UK) · PL405460019 · revised February 20, 2026
[2]FDA DailyMed · 031091ad-a397-26… · revised August 16, 2023 [PDF]

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised February 20, 2026[1]

Summary of the safety profile Strontium ranelate has been studied in clinical trials involving nearly 8,000 participants. Long-term safety has been evaluated in postmenopausal women with osteoporosis treated for up to 60 months with strontium ranelate 2 g/day (n=3,352) or placebo (n=3,317) in phase III studies.
Mean age was 75 years at inclusion and 23% of the patients enrolled were 80 to 100 years of age. In a pooled analysis of randomised placebo-controlled studies in post-menopausal osteoporotic patients, the most common adverse reactions consisted of nausea and diarrhoea, which were generally reported at the beginning of treatment with no noticeable difference between groups afterwards.
Discontinuation of therapy was mainly due to nausea. There were no differences in the nature of adverse reactions between treatment groups regardless of whether patients were aged below or above 80 at inclusion. Tabulated list of adverse reactions The following adverse reactions have been reported during clinical studies and/or post marketing use with strontium ranelate.
Adverse reactions are listed below using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
4)# § Frequency in Clinical Trials was similar in the drug and placebo group. * In Asian countries reported as rare # For adverse reaction not observed in clinical trials, the upper limit of the 95% confidence interval is not higher than 3/X with X representing the total sample size summed up across all relevant clinical trials and studies.
a Musculo-skeletal fraction > 3 times the upper limit of the normal range. In most cases, these values spontaneously reverted to normal without change in treatment. 4). 38]). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard. 4)# Musculoskeletal and connective tissue disorders Very common Musculoskeletal pain (muscle spasm, myalgia, bone pain, arthralgia and pain in extremity)§ Common Peripheral oedema Pyrexia (in association with hypersensitivity skin reactions) General disorders and administration site conditions Uncommon Malaise Investigations Common Blood Creatine phosphokinase (CPK) increaseda

GBOfficial regulatory label· Warnings and precautions· revised February 20, 2026[1]

8). Before starting treatment, patients should be evaluated with respect to cardiovascular risk. g. 8). During Strontium ranelate Aristo treatment, these cardiovascular risks should be monitored on a regular basis generally every 6 to 12 months.
3). 8). The cause of this finding is unknown. 3) and should be used with caution in patients at risk of VTE. When treating patients over 80 years at risk of VTE, the need for continued treatment with Strontium ranelate Aristo should be re-evaluated.
3) and adequate preventive measures taken. Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile. When a VTE occurs, Strontium ranelate Aristo should be stopped. 2). In accordance with good medical practice, periodic assessment of renal function is recommended in patients with chronic renal impairment.
Continuation of treatment with Strontium ranelate Aristo in patients developing severe renal impairment should be considered on an individual basis. Skin reactions Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of strontium ranelate.
Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 3-6 weeks for DRESS. g. g. g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, Strontium ranelate Aristo treatment should be discontinued immediately.
The best results in managing SJS, TEN or DRESS come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. The outcome of DRESS is favorable in most cases upon discontinuation of strontium ranelate and after initiation of corticosteroid therapy when necessary.
Recovery could be slow and recurrences of the syndrome have been reported in some cases after discontinuation of corticosteroid therapy. If the patient has developed SJS, TEN or DRESS with the use of strontium ranelate, Strontium ranelate Aristo must not be re-started in this patient at any time.

This is not medical advice. Consult a qualified healthcare professional.