LEVOMEFOLATE: 49 Adverse Event Reports & Safety Profile
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Active Ingredient: LEVOMEFOLATE CALCIUM · Route: ORAL · Manufacturer: PureTek Corporation · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 1980 · Latest Report: 20240318
What Are the Most Common LEVOMEFOLATE Side Effects?
All LEVOMEFOLATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Anxiety | 6 | 12.2% | 0 | 1 |
| Drug ineffective | 6 | 12.2% | 0 | 0 |
| Foetal exposure during pregnancy | 6 | 12.2% | 0 | 3 |
| Headache | 6 | 12.2% | 0 | 1 |
| Weight increased | 6 | 12.2% | 0 | 2 |
| Drug hypersensitivity | 5 | 10.2% | 0 | 0 |
Who Reports LEVOMEFOLATE Side Effects? Age & Gender Data
Gender: 53.8% female, 46.2% male. Average age: 48.9 years. Most reports from: US. View detailed demographics →
Is LEVOMEFOLATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 1 |
| 2010 | 1 | 0 | 0 |
| 2012 | 1 | 0 | 0 |
| 2015 | 3 | 0 | 0 |
| 2016 | 4 | 0 | 1 |
| 2017 | 3 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
| 2020 | 5 | 0 | 0 |
| 2021 | 5 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2024 | 1 | 0 | 0 |
What Is LEVOMEFOLATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 16 |
| Depression | 5 |
Official FDA Label for LEVOMEFOLATE
Official prescribing information from the FDA-approved drug label.
Drug Description
DESCRIPTION Folixate ™ is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate level and Vitamin D supplementation due to Vitamin D deficiency. Folixate ™ should be administered under the supervision of a licensed healthcare practitioner. Each tablet contains: Folate (as L-5-Methyltetrahydrofolate calcium salt)......1700 mcg DFE (1000 mcg of L-5-methylfolate) Vitamin D3 (as Cholecalciferol)………....................125 mcg (5000 IU) Each tablet contains the following inactive ingredients: Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate, Vegetable Stearic Acid.
FDA Approved Uses (Indications)
INDICATIONS AND USAGE Folixate ™ is indicated for dietary management of patients with unique nutritional needs requiring increased folate level and Vitamin D supplementation. Folixate™ can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.
Dosage & Administration
DOSAGE AND ADMINISTRATION Take one tablet daily or as directed by a licensed healthcare practitioner.
Contraindications
CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Folixate ™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of Vitamin D, and hypervitaminosis D.
Known Adverse Reactions
ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folate. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-877-921-7873.
Warnings
WARNINGS AND PRECAUTIONS 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. Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.