FOLATE: 925 Adverse Event Reports & Safety Profile
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Active Ingredient: FOLATE SODIUM · Route: ORAL · Manufacturer: Oncora Pharma, LLC · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 1999 · Latest Report: 20250101
What Are the Most Common FOLATE Side Effects?
All FOLATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pneumonia | 506 | 54.7% | 1 | 22 |
| Asthma | 495 | 53.5% | 0 | 21 |
| Vomiting | 487 | 52.7% | 0 | 3 |
| Drug hypersensitivity | 484 | 52.3% | 0 | 0 |
| Oedema | 473 | 51.1% | 0 | 0 |
| Dyspnoea | 448 | 48.4% | 0 | 12 |
| Wheezing | 435 | 47.0% | 0 | 0 |
| Pain | 270 | 29.2% | 0 | 14 |
| Malaise | 262 | 28.3% | 0 | 0 |
| Respiratory tract infection | 262 | 28.3% | 0 | 18 |
| Chest pain | 233 | 25.2% | 0 | 0 |
| Cough | 226 | 24.4% | 0 | 7 |
| Foetal exposure during pregnancy | 184 | 19.9% | 28 | 28 |
| Nasal oedema | 141 | 15.2% | 0 | 0 |
| Off label use | 71 | 7.7% | 35 | 45 |
| Congenital umbilical hernia | 67 | 7.2% | 0 | 0 |
| Abortion spontaneous | 52 | 5.6% | 30 | 32 |
| Maternal exposure during pregnancy | 47 | 5.1% | 19 | 24 |
| Alanine aminotransferase increased | 44 | 4.8% | 31 | 44 |
| Exposure during pregnancy | 44 | 4.8% | 18 | 18 |
Who Reports FOLATE Side Effects? Age & Gender Data
Gender: 74.3% female, 25.7% male. Average age: 52.3 years. Most reports from: CA. View detailed demographics →
Is FOLATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 1 |
| 2010 | 22 | 18 | 22 |
| 2011 | 2 | 0 | 2 |
| 2012 | 13 | 10 | 10 |
| 2013 | 1 | 0 | 0 |
| 2014 | 2 | 0 | 0 |
| 2015 | 2 | 0 | 1 |
| 2016 | 4 | 0 | 1 |
| 2017 | 34 | 11 | 12 |
| 2018 | 51 | 2 | 5 |
| 2019 | 1 | 0 | 1 |
| 2020 | 9 | 1 | 4 |
| 2021 | 6 | 0 | 0 |
| 2022 | 2 | 1 | 0 |
| 2023 | 4 | 0 | 2 |
| 2024 | 4 | 0 | 0 |
| 2025 | 1 | 0 | 0 |
What Is FOLATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 704 |
| Supplementation therapy | 60 |
| Foetal exposure during pregnancy | 20 |
| Toxicity to various agents | 18 |
| Vitamin supplementation | 18 |
| Choriocarcinoma | 6 |
FOLATE vs Alternatives: Which Is Safer?
Official FDA Label for FOLATE
Official prescribing information from the FDA-approved drug label.
Drug Description
Foltira is an orally administered prescription folate product.
FDA Approved Uses (Indications)
Foltira is for patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.
Dosage & Administration
Take one tablet daily or as directed by a licensed medical practitioner. If you are pregnant or nursing ask a healthcare professional.
Warnings
Keep out of reach of children.
Precautions
Foltira should be administered under the supervision of a licensed medical practitioner.