What the label lists and what reports show
Alendronate and cholecalciferol side effects
Alendronate and cholecalciferol's FDA label: “Most common adverse reactions (greater than or equal to 3%) for alendronate are: abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea.” FAERS holds 2,764 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is femur fracture (1,407 reports).
- No generic listed
Check it at the source: the alendronate and cholecalciferol FDA label on DailyMed (effective February 3, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of FOSAMAX PLUS D?FOSAMAX PLUS D may cause serious side effects. See "What is the most important information I should know about FOSAMAX PLUS D?" The most common side effects of FOSAMAX PLUS D are: Stomach area (abdominal) pain Heartburn Constipation Diarrhea Upset stomach Pain in your bones, joints, or muscles Nausea You may get allergic reactions, such as hives or swelling of your face, lips, tongue, or throat. Worsening of asthma has been reported. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of FOSAMAX PLUS D. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How do I store FOSAMAX PLUS D? Store FOSAMAX PLUS D at room temperature, 68°F to 77°F (20°C to 25°C). Keep FOSAMAX PLUS D away from light. […]
Source: FDA drug label, Organon LLC, effective February 3, 2026 (SPL set 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (greater than or equal to 3%) for alendronate are: abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea.
From the label: adverse reactions, continuedThe following clinically significant adverse drug reactions are described elsewhere in the labeling: Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.1) ] Mineral Metabolism [see Warnings and Precautions (5.2) ] Musculoskeletal Pain [see Warnings and Precautions (5.3) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions (5.5) ] Renal Impairment [see Warnings and Precautions (5.6) ] Most common adverse reactions (greater than or equal to 3%) for alendronate are: abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. FOSAMAX Treatment of Osteoporosis in Postmenopausal Women FOSAMAX Daily The safety of FOSAMAX in the treatment of postmenopausal osteoporosis was assessed in four clinical trials that enrolled 7453 women aged 44-84 years. …
Source: FDA drug label, Organon LLC, effective February 3, 2026 (SPL set 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,764 reports list alendronate and cholecalciferol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 128 are coded as a death and 1,729 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Alendronate and cholecalciferol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions