Over-the-counter medication · B Vitamin (Folate) Supplement
folic acid
Also sold as Folvite. Integra FTM treats iron deficiency anemia and folate deficiency anemia.
Data updated 2026-05-15
- 241,433
- FDA reportsHeavily reported
- 5
- InteractionsFew interactions
- 6
- Recall records
What the data shows
folic acid (Folvite) is an over-the-counter B Vitamin (Folate) Supplement, in the top 5% of tracked drugs by FAERS report volume (241,433 FDA reports), with 5 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
folic acid (Folvite) is an over-the-counter B Vitamin (Folate) Supplement. Integra FTM treats iron deficiency anemia and folate deficiency anemia.
Integra FTM is a medicine that helps treat iron and folate deficiencies. It is also used during pregnancy to prevent and treat iron deficiency and provide folic acid.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.02/unit
Generic Available
Yes (9 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Integra FTM treats iron deficiency anemia and folate deficiency anemia.
Common side effects
Upset stomach, Nausea, Diarrhea
Key warnings
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in young children.
The sections below are summarized in plain English from folic acid's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Integra FTM contains two types of iron that your body can use. These iron types help to increase the amount of iron in your blood. Folic acid is a B vitamin that helps your body make new blood cells.
How to Take It
Adults and children over 12 should take one capsule daily. Take it between meals, or as your doctor tells you. Do not take more than the recommended dose. Do not give this medicine to children under 12 years old.
This is a plain-language summary of folic acid's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Integra FTM can be used during pregnancy to prevent and treat iron deficiency and to provide folic acid. Talk to your doctor before taking this medicine if you are pregnant or breastfeeding.
This is a plain-language summary of folic acid's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of folic acid's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Integra FTM in a cool, dry place, away from light and moisture, and out of reach of children.
Side Effects (from patient reports)
Based on 241,433 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for folic acid, by number of reports
- Feeling tired
Feeling tired
23,332 reports
- Pain
Pain
23,058 reports
- Joint pain
Joint pain
19,493 reports
- Rheumatoid arthritis
Rheumatoid arthritis
17,527 reports
- Feeling sick to your stomach
Feeling sick to your stomach
15,636 reports
- Headache
Headache
14,211 reports
- Diarrhea
Diarrhea
14,143 reports
- Skin rash
Skin rash
13,596 reports
- Difficulty breathing
Difficulty breathing
13,155 reports
- Hair loss
Hair loss
11,667 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for folic acid each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where folic acid sits
folic acid has more FDA adverse-event reports than 96% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is folic acid; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 241,433 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
241,433
Reports Mentioning Death
22,144
9.2% of reports — not proof of cause
Hospitalization Reports
87,188
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | FATIGUE | 23,332 |
| 3 | PAIN | 23,054 |
| 4 | ARTHRALGIA | 19,495 |
| 5 | RHEUMATOID ARTHRITIS | 17,528 |
| 7 | NAUSEA | 15,633 |
| 8 | HEADACHE | 14,211 |
| 9 | DIARRHOEA | 14,142 |
| 10 | RASH | 13,595 |
| 11 | DYSPNOEA | 13,157 |
| 12 | ALOPECIA | 11,667 |
| 13 | ABDOMINAL DISCOMFORT | 11,665 |
| 14 | JOINT SWELLING | 11,529 |
| 15 | CONDITION AGGRAVATED | 11,126 |
| 16 | VOMITING | 10,810 |
| 17 | PNEUMONIA | 10,795 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in young children. Keep this medicine away from children. If someone overdoses, call a doctor or poison control center right away. Folic acid alone is not the right treatment for pernicious anemia or other megaloblastic anemias where Vitamin B12 is lacking.
Known Drug Interactions
With oral dapsone treatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood of hematologic reactions.
Mechanism: Using these drugs together can increase the chance of having blood problems because they both affect how your body handles folic acid.
What to do: Your doctor should monitor your blood counts and watch for signs of blood-related side effects.
In RA, concomitant medications besides MTX were nonsteroidal anti-inflammatory agents (NSAIDs), folic acid, corticosteroids and/or narcotics. In PsA clinical trials, concomitant medications included MTX in approximately half of the patients as well as NSAIDs, folic acid and corticosteroids.
Mechanism: There is no known negative interaction between these two drugs, and they are frequently used together to manage rheumatoid arthritis.
What to do: It is generally safe to take these medications together as directed by your doctor.
Folic Acid Coadministration of methotrexate with folic acid or its derivatives decreases the clinical effectiveness of methotrexate in patients with neoplastic diseases.
Mechanism: Folic acid can interfere with how methotrexate works to treat cancer, making the medication less effective.
What to do: Talk to your doctor before taking folic acid, as it may stop your methotrexate treatment from working as well as it should.
Table 1: Drugs That Affect Phenytoin Concentrations Interacting Agent Examples Drugs that may increase phenytoin serum levels Antiepileptic drugs Ethosuximide, felbamate, oxcarbazepine, methsuximide, topiramate Azoles Fluconazole, ketoconazole, itraconazole, miconazole, voriconazole Antineoplastic agents Capecitabine, fluorouracil Antidepressants Fluoxetine, fluvoxamine, sertraline Gastric acid reducing agents H 2 antagonists (cimetidine), omeprazole Sulfonamides Sulfamethizole, sulfaphenazole, sulfadiazine, sulfamethoxazole trimethoprim Other Acute alcohol intake, amiodarone,...
Mechanism: Taking these two together can cause the levels of both drugs in your blood to drop, making them both less effective.
What to do: Your doctor may need to monitor your blood levels and adjust the doses for both your phenytoin and your folic acid supplement.
• Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. • Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. • Colestipol: Reduces folic acid absorption and reduces serum folate levels.
Mechanism: Taking a folic acid supplement along with a multivitamin that already contains it increases the total amount of this vitamin in your body.
What to do: Consult your healthcare provider to make sure the total amount of folic acid you are taking is safe and necessary.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I do if I accidentally take too much Integra FTM?
Can I take Integra FTM with food?
Will Integra FTM change the color of my stool?
Can children take Integra FTM?
Is it okay to take other supplements while taking Integra FTM?
What if I have a history of stomach ulcers?
How often should I have blood tests while taking this medicine?
What does 'Rx only' mean?
Can folic acid hide the symptoms of pernicious anemia?
When is the best time to take Integra FTM?
What are the common side effects of folic acid?
Does folic acid interact with other medications?
What drug class is folic acid?
Is folic acid safe during pregnancy?
Has folic acid been recalled?
Active Recalls
Presence of a Foreign Substance; black particles observed in liquid
Safecor Health, LLC
Lack of Assurance of Sterility
TMC Acquisition LLC dba Tailor Made Compounding
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Related Medications in B Vitamin (Folate) Supplement
Other drugs grouped near folic acid - same-class peers and common alternatives.
ascorbic acid
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biotin
Vitamin B7
Dialyvite with Zinc is a prescription vitamin supplement.
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calcitriol
Rocaltrol
Calcitriol is a form of vitamin D that helps your body absorb and use calcium.
Compare with folic acid →
calcium carbonate
Tums, Caltrate
Calcium carbonate is a medicine that can relieve heartburn and upset stomach.
Compare with folic acid →
cholecalciferol
Vitamin D3
PNV-DHA is a multivitamin with minerals and essential fatty acids.
Compare with folic acid →
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What the FDA Data Shows for folic acid
The FDA label for folic acid (sold under brand names such as Folvite) classifies it as an over-the-counter product in the B Vitamin (Folate) Supplement class. Integra FTM treats iron deficiency anemia and folate deficiency anemia. Official labeling lists 7 commonly reported side effects, including Upset stomach, Nausea, Diarrhea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 241,433 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.02.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 6 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: November 8, 2022
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages