CHOLECALCIFEROL: 12,018 Adverse Event Reports & Safety Profile
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Drug Class: Vitamin D [CS] · Route: ORAL · Manufacturer: BonGeo Pharmaceuticals, Inc. · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 1961 · Latest Report: 20250806
What Are the Most Common CHOLECALCIFEROL Side Effects?
All CHOLECALCIFEROL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 2,792 | 23.2% | 715 | 1,304 |
| Off label use | 2,642 | 22.0% | 1,176 | 1,735 |
| Fatigue | 2,303 | 19.2% | 1,048 | 1,168 |
| Pain | 2,230 | 18.6% | 831 | 1,124 |
| Vomiting | 1,898 | 15.8% | 1,087 | 1,066 |
| Dyspnoea | 1,837 | 15.3% | 889 | 1,229 |
| Headache | 1,822 | 15.2% | 975 | 1,074 |
| Arthralgia | 1,768 | 14.7% | 1,039 | 960 |
| Rash | 1,674 | 13.9% | 947 | 970 |
| Nausea | 1,672 | 13.9% | 854 | 1,034 |
| Systemic lupus erythematosus | 1,664 | 13.9% | 1,027 | 1,002 |
| Wheezing | 1,656 | 13.8% | 985 | 1,299 |
| Abdominal discomfort | 1,648 | 13.7% | 893 | 975 |
| Pyrexia | 1,623 | 13.5% | 805 | 1,028 |
| Diarrhoea | 1,611 | 13.4% | 1,008 | 941 |
| Dizziness | 1,595 | 13.3% | 992 | 984 |
| Condition aggravated | 1,588 | 13.2% | 909 | 1,056 |
| Psoriatic arthropathy | 1,583 | 13.2% | 986 | 952 |
| Malaise | 1,526 | 12.7% | 944 | 1,062 |
| Rheumatoid arthritis | 1,516 | 12.6% | 1,027 | 994 |
Who Reports CHOLECALCIFEROL Side Effects? Age & Gender Data
Gender: 72.2% female, 27.8% male. Average age: 55.3 years. Most reports from: CA. View detailed demographics →
Is CHOLECALCIFEROL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 2 | 0 | 2 |
| 2001 | 3 | 0 | 3 |
| 2002 | 3 | 0 | 2 |
| 2004 | 2 | 1 | 2 |
| 2005 | 12 | 1 | 10 |
| 2006 | 5 | 0 | 1 |
| 2007 | 9 | 1 | 1 |
| 2008 | 56 | 3 | 14 |
| 2009 | 13 | 0 | 3 |
| 2010 | 29 | 2 | 13 |
| 2011 | 37 | 15 | 8 |
| 2012 | 41 | 2 | 14 |
| 2013 | 84 | 0 | 44 |
| 2014 | 155 | 4 | 86 |
| 2015 | 264 | 35 | 150 |
| 2016 | 257 | 14 | 163 |
| 2017 | 411 | 48 | 174 |
| 2018 | 421 | 34 | 281 |
| 2019 | 429 | 31 | 211 |
| 2020 | 321 | 29 | 128 |
| 2021 | 290 | 53 | 105 |
| 2022 | 241 | 40 | 89 |
| 2023 | 260 | 1 | 106 |
| 2024 | 225 | 51 | 106 |
| 2025 | 99 | 24 | 61 |
What Is CHOLECALCIFEROL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 8,150 |
| Vitamin supplementation | 507 |
| Rheumatoid arthritis | 419 |
| Vitamin d deficiency | 418 |
| Osteoporosis | 183 |
| Foetal exposure during pregnancy | 127 |
| Supplementation therapy | 86 |
| Prophylaxis | 78 |
| Psoriasis | 78 |
| Hypovitaminosis | 59 |
CHOLECALCIFEROL vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Vitamin D [CS]
Official FDA Label for CHOLECALCIFEROL
Official prescribing information from the FDA-approved drug label.
Drug Description
Supplement Facts Serving Size: 1 mL Servings Per Container: 50 Amount per serving % Daily Value Percent Daily Value (%DV) based on a 2000 calorie diet. Vitamin D 400 IU 100% Fluoride (sodium fluoride) 0.25 mg Daily Value not established.
Other
Ingredients: Glycerin, water, polysorbate 80, sodium hydroxide, propylene glycol, sucralose, fruit flavor, methyl paraben, caramel color and propyl paraben.
FDA Approved Uses (Indications)
How to Use Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper. Do not accept if tamper evident box seal is broken or missing. The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.
Dosage & Administration
DOSAGE: Usual adult dose is 1 tablet by mouth daily once daily, or as prescribed by a licensed medical practitioner.
Warnings
WARNINGS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Folvitra
Tablets should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Precautions
PRECAUTIONS: CONTRAINDICATIONS This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
Precautions
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Adverse Reactions
Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur. KEEP OUT OF THE REACH OF CHILDREN.
Active Ingredient
Capsicum annuum extract
Inactive Ingredients
Hydrogenated Dicyclopentadiene/Isopentene/Isoprene/Styrene Copolymer (and)
Mineral
Oil (and)
Hydrogenated Styrene/Butadiene
Copolymer, coffee seed extract, soil mineral, cordycepin