Cholecalciferol
Vitamin D and Analogues
Sold as FOSAMAX PLUS D
- Drug class
- Vitamin D and Analogues
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 2
- Products on record
- 40
- FDA reports (12 mo)
- 15
Overview
Plain-language summary, compiled from the cited regulatory records
Cholecalciferol is a vitamin D analogue [1]. It is approved for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis [1]. Cholecalciferol should not be used alone to treat vitamin D deficiency [1]. The optimal duration for its use has not been determined, and discontinuation may be considered for patients at low risk for fracture after 3 to 5 years of treatment [1].
Cholecalciferol is available under various brand names, including FOSAMAX PLUS D [1]. In the past 12 months, there have been 15 adverse event reports associated with this active ingredient [2]. The most frequently reported reactions include arthralgia, headache, back pain, cellulitis, and reports of the drug being ineffective [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 39 | April 10, 2026 |
| US United States | FDA | 1 | February 3, 2026 |
GBUnited Kingdom· MHRA
39 products
Uses
Initial treatment of clinically relevant vitamin D deficiency in adults.
How to take
USUnited States· FDA
1 product
Uses
2 ) Limitations of use : FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. 3 ) Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.
1 Treatment of Osteoporosis in Postmenopausal Women FOSAMAX ® PLUS D is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX PLUS D increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
2) ] . 3 Important Limitations of Use FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. The optimal duration of use has not been determined. The safety and effectiveness of FOSAMAX PLUS D for the treatment of osteoporosis are based on clinical data of four years duration.
All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
Drug interactions
Known interactions involving Cholecalciferol. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL413440001 · revised May 20, 2022
- [2]FDA DailyMed · 10307e7e-9a84-4a… · revised February 3, 2026 [PDF]
- [3]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
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.