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Cholecalciferol Side Effects

The most commonly reported side effects of cholecalciferol include off label use, fatigue, and diarrhoea, based on 55,180 FDA adverse event reports from 2004 to 2025. 7.1% of reports found the drug to be ineffective.

Cholecalciferol side effects

Percentages show how often each reaction appears relative to total reports for cholecalciferol.

1
Off Label Use10.4%5,749
2
Fatigue9.9%5,490
3
Diarrhoea8.6%4,767
4
Nausea8.1%4,451
5
Dyspnoea7.4%4,092
6
Pain7.3%4,025
7
Headache7.3%4,007
8
Drug Ineffective7.1%3,894
9
Arthralgia7.1%3,894
10
Vomiting6.9%3,816
11
Condition Aggravated6.6%3,636
12
Pyrexia6.5%3,561
13
Asthenia6.3%3,461
14
Dizziness5.7%3,157
15
Rash5.6%3,070

These are voluntary reports and do not establish that cholecalciferol caused these reactions.

Report severity

86.1%Serious47,483 reports
50.2%Hospitalizations27,681 reports
12.5%Fatal6,889 reports

Seriousness is determined by the reporter, not by OpenClaim.

Cholecalciferol drug interactions

Other drugs that appear in adverse event reports alongside cholecalciferol. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Alendronate-sodium10.6%5,829
2
Methotrexate8.7%4,796
3
Infliximab8.7%4,783
4
Acetaminophen8.1%4,481
5
Adalimumab7.9%4,376
6
Prednisone7.9%4,352
7
Rituximab7.8%4,313
8
Etanercept7.0%3,862
9
Abatacept6.7%3,714
10
Tocilizumab6.7%3,709
11
Leflunomide6.2%3,429
12
Certolizumab-pegol6.2%3,429
13
Folic-acid6.0%3,299
14
Diclofenac5.7%3,160
15
Pantoprazole-sodium5.7%3,159

Taken alongside

1
Acetaminophen21.9%12,111
2
Pantoprazole-sodium17.2%9,500
3
Aspirin15.4%8,483
4
Levothyroxine-sodium14.4%7,925
5
Omeprazole12.7%6,992
6
Atorvastatin-calcium12.0%6,640
7
Folic-acid11.3%6,227
8
Calcium11.2%6,156
9
Albuterol10.8%5,968
10
Amlodipine10.6%5,853
11
Prednisone10.3%5,710
12
Furosemide9.8%5,425
13
Cyanocobalamin9.4%5,192
14
Ergocalciferol8.9%4,925
15
Ondansetron8.2%4,501

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports cholecalciferol side effects

58.3% of cholecalciferol adverse event reports involve female patients and 32.0% involve male patients. The largest age group is elderly at 48%. These figures reflect who reports side effects, not underlying risk.

Sex

Female58.3%
Male32.0%
Unknown9.7%

Age group

< 21.3%
2–112.5%
12–172.4%
18–6446.1%
65+47.8%

What is cholecalciferol used for

Conditions and purposes for which patients were taking cholecalciferol when the adverse event was reported.

Acute Kidney InjuryAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAdverse Drug ReactionAdverse EventAnaemiaAnalgesic TherapyAnkle FractureAnkylosing SpondylitisArthralgiaArthritisAtrial FibrillationAbdominal DistensionAbdominal PainAcne

Showing 15 of 573 indications

Cholecalciferol brand names and reporting trend

Cholecalciferol is sold under the brand name Infuvite Adult.

Brand names

Infuvite Adult57,872

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking cholecalciferol with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.