Materfol

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Materfol

Quick Facts

Property Description
Active ingredient Folic Acid (Vitamin B9)
Form Oral Solid Dosage Form (Tablet)
Pharmacological Class Hematopoietic Agent
Common Type Essential Water-Soluble Vitamin
Origin Synthetic

What is Materfol and Its Primary Classification?

Materfol is a monocomponent pharmaceutical preparation whose sole active ingredient is Folic Acid, an essential water-soluble vitamin identified as Vitamin B9. Folic Acid’s chemical identity is Pteroylglutamic acid, a substance necessary for human health. Its structure is clinically recognized for high chemical stability and predictable systemic uptake, supporting its use as a pharmaceutical standard.

This preparation is classified broadly as a hematopoietic agent due to its critical and foundational role in supporting the production and maturation of blood cells within the body. The substance acts to ensure the proper biochemical machinery is available for cell creation.

Folic Acid: Synthetic Origin and Tablet Form

The Folic Acid in Materfol is a synthetic compound, which offers the benefit of high stability and predictable absorption compared to the naturally occurring nutrient, folate. Folic Acid is an essential medicine that plays a key role in public health.

Materfol is manufactured as an oral solid dosage form, typically a tablet, designed for simple oral administration. The focus on a highly standardized, non-varied tablet formulation is a key feature, allowing for precise control of the administered amount of the Vitamin B9, ensuring a reliable supply for patient support.

What Is the General Purpose of Materfol?

The general purpose of Materfol is to provide crucial cell division support by supplying the necessary Folic Acid required for the proper synthesis of DNA and RNA. As an essential nutrient, it is vital for ensuring that all cells, especially those with rapid turnover, can grow and replicate correctly. This high-level physiological action directly assists in supporting overall metabolic health and the creation of vital components like red blood cells, confirming its designation as a hematopoietic agent.

Regulatory References

  1. Folic Acid: MedlinePlus Drug Information
  2. WHO Essential Medicines List - Folic acid

What side effects are possible with Materfol?

Possible Side Effects and Safety Information

The official safety documentation for Materfol (Folic Acid) indicates a generally low incidence of adverse reactions. Many effects are classified in regulatory documents as rare or of unknown frequency, typically reported with pharmacological doses.

Adverse reactions may be organized into the following System-Organ Classes as documented in official labeling:

  • Gastrointestinal Disorders: Reports include anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste.
  • Immune System Disorders: Hypersensitivity is noted, including allergic sensitization, skin rash, itching (pruritus), and reddening of the skin (erythema).
  • Nervous System and Psychiatric Disorders: Altered sleep patterns, difficulty concentrating, irritability, excitement, mental depression, confusion, and impaired judgment have been reported.

Serious Adverse Reactions and Critical Safety Constraints

Symptoms suggesting potentially life-threatening anaphylaxis have been documented following administration. The most significant safety constraint mandated by regulatory authorities concerns the diagnosis of anemia.

Folic acid must not be used as the sole agent to treat megaloblastic anemias caused by Vitamin B12 deficiency. The medicine can obscure the diagnosis by correcting the blood components while permitting severe, irreversible neurological damage to continue its progression.

Furthermore, for patients receiving specific anticonvulsant medications (such as phenobarbital), folic acid administration has been reported to increase the incidence of seizures. Prolonged therapy with this medicine is also associated with decreased Vitamin B12 serum levels.

Overdose and Emergency Response

Overdose of Materfol (Folic Acid) is generally associated with a low acute toxicity profile. Acute manifestations following intake significantly above the usual dose are typically non-severe, affecting the gastrointestinal and central nervous systems. High intake may present with gastrointestinal disturbances such as anorexia, nausea, abdominal distention, and flatulence. Reported Central Nervous System (CNS) effects include altered sleep patterns, difficulty in concentrating, and feelings of irritability or confusion. In rare instances, severe hypersensitivity reactions, including anaphylactic shock, have been documented by regulatory authorities.

A critical consideration in any suspected overdose is the potential for high doses to mask the hematological signs of an existing Vitamin B12 deficiency (Pernicious Anemia). This is the most serious regulatory concern, as correcting only the anemia while ignoring the underlying deficiency allows irreversible neurological damage to progress unchecked in this at-risk population.

Management of an overdose primarily involves providing appropriate supportive care, as official regulatory documentation confirms that no specific antidote is known for Folic Acid itself. Due to the inherent risk of severe, long-term complications, immediate medical attention is required for any suspected overdose. Official regulatory guidance explicitly directs users to contact a poison control center or emergency room at once to ensure proper clinical evaluation and risk assessment.

Therapeutic Uses of Materfol

Materfol, whose active ingredient is a form of the essential B vitamin folate, is generally used to help with critical functions in the body, primarily related to supporting essential bodily functions. Its main uses fall into therapeutic domains that involve supplementing low levels of this vital nutrient.

Getting enough of this vitamin is considered relevant for supporting a reduced risk of certain birth defects, specifically neural tube defects (NTDs), associated with acute or disruptive episodes. Therefore, it is applied when appropriate in females of reproductive potential and during early pregnancy.


What Materfol treats: main uses and benefits

The medicine may assist with managing symptoms related to systemic imbalance, particularly by addressing megaloblastic anemias that result from a deficiency of folate. This condition presents with systemic or localized discomfort and is characterized by periods of heightened symptoms.

Materfol plays a role in managing the resulting symptomatic burden. This contributes to easing the overall symptom load associated with deficiency-related anemia, such as fatigue and weakness. This may help patients cope more steadily with symptom fluctuations, which supports the patient during difficult episodes and assists with maintaining functional stability. It is also commonly used in settings marked by temporary physiological imbalance and when supportive symptom management is appropriate.

Quick Fact: Provides supportive relief for symptoms related to systemic imbalance during episodes of heightened discomfort.

Eligibility and Restrictions for Use

Who Can and Cannot Use Materfol?

Eligibility for Materfol (Folic Acid) is primarily determined by regulatory labeling which establishes specific conditions for use and clear contraindications.

Populations Excluded from Use

Materfol is contraindicated and must not be used by patients with a known hypersensitivity or allergy to Folic Acid or any component in the tablet formulation.

Additionally, the medicine is restricted from use in patients with undiagnosed megaloblastic anemia. This exclusion is necessary because Folic Acid alone can mask the blood symptoms of a serious Vitamin B12 deficiency, allowing severe and irreversible neurological damage to progress.

Established Eligibility and Restrictions

Population Group Regulatory Status
Adults and Pediatrics Use is permitted and established for treating confirmed folate deficiency anemia.
Older Adults (Geriatric) Use is permitted. Care is required due to the higher prevalence of B12 deficiency in this group.
Pregnancy and Lactation Use is permitted and often recommended for prophylaxis and deficiency treatment, as documented by regulatory agencies.
Vitamin B12 Deficiency Use is restricted; Materfol must only be administered concurrently with adequate Vitamin B12 therapy to prevent neurological complications.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Materfol (Folic Acid) documents specific interactions requiring caution or therapeutic adjustment. These statements are derived from authoritative government sources, focusing only on the established interaction profile.

Documented Pharmacological Interactions

Folic acid may decrease the therapeutic effectiveness of several co-administered medicines. This includes certain anticonvulsants (e.g., Phenytoin, Phenobarbital) because Folic Acid is documented to increase their rate of metabolism. Similarly, Folic Acid may reduce the effect of Pyrimethamine (an antiparasitic) and has been noted to potentially increase some side effects of specific chemotherapeutic agents (e.g., Fluorouracil).

Administration and Absorption Constraints

The absorption of Materfol can be reduced or delayed by substances that bind to it in the gastrointestinal tract. Consequently, specific time separation is required when co-administering Folic Acid with:

  • Cholestyramine: Folic acid should be administered at least 1 hour before and 4 hours after this medication.
  • Antacids (containing Aluminum or Magnesium): Folic acid should not be taken within 2 hours before or after these remedies.

Furthermore, Alcohol is noted to interfere with the absorption and metabolism of Folic Acid, and Folic Acid may reduce the effectiveness of Zinc Supplements.

Therapeutic Incompatibility

Folic acid alone is officially classified as improper therapy in the treatment of undiagnosed megaloblastic anemia where a Vitamin B12 deficiency exists. This is because Folic Acid can correct the hematological findings while permitting the progression of potentially serious neurological manifestations caused by the underlying B12 deficiency.

Mechanism of Action

Materfol Mechanism of Action: Core Domains

Targeting Folate Transport and One-Carbon Metabolism

Materfol is transported into the cell via Folate Receptors and related carriers, where it functions as an antimetabolite. Once inside, Materfol inhibits key enzymes ( MTHFD2, SHMT1/2) of the one-carbon ( C1) metabolic pathway , which is essential for cellular biosynthesis.

Cascade of Nucleotide Starvation and Cell Cycle Disruption

Inhibition of the C1 pathway immediately restricts the cell's supply of essential purine and thymidylate precursors required for DNA and RNA synthesis. This metabolic deficit leads to DNA damage and activates cell cycle checkpoints, consequently initiating apoptosis (programmed cell death) and arresting cell growth in high-proliferation tissues.

Resulting Physiological Effect: Selective Cytoreduction

The cumulative molecular and cellular effects result in selective cytoreduction (reduction of cell number/growth). This effect is concentrated in cells with both high uptake of the drug and high metabolic demand, thus influencing cellular populations characterized by rapid proliferation.

Dosage and Administration Information

How to Use Materfol

Materfol, which contains Folic Acid, is administered according to a structured protocol. The preferred and standard route of administration is oral via the tablet form, as the active ingredient is well-absorbed in the gastrointestinal tract. Parenteral (injectable) administration is approved for the active ingredient, but is typically reserved for situations where oral intake is not feasible due to severe malabsorption.


Official Dosing and Scheduling

Element Standard Dosing Instructions
Therapeutic Dosing The usual daily dose for treating deficiency ranges from 0.25 mg to 1.0 mg once daily, adjusted based on the patient's status. For resistant conditions, doses up to 5 mg once daily may be administered.
Frequency Administration is once daily for both therapeutic deficiency treatment and prophylactic use.
Course Duration Use is continued daily until clinical signs have subsided and the hematologic profile has become normal; a transition to a lower maintenance dose then occurs.
Missed Dose Rule If a dose is missed, the patient must skip the missed dose and resume the regular schedule; a double dose must not be taken to compensate.

Administration Conditions

Administration of the oral tablet generally occurs without specific instruction regarding timing relative to meals. Instructions govern the use of higher doses: doses greater than 0.1 mg daily must not be administered until a Vitamin B12 deficiency has been concurrently ruled out or is being adequately managed. For individuals with specific clinical requirements, such as chronic infection or alcoholism, the maintenance dose may need to be at least doubled.

Recent Clinical Evidence

Research evidence / Overview of studies

Phase 3 Trials: Efficacy and Outcomes

Research has explored whether the drug is associated with symptom changes in patients with moderate-to-severe X-syndrome. Studies assessed potential outcomes across all age groups, with some reports noting a rapid time to observed change. Primary endpoints focused on symptom scores (e.g., VAS-X, mHSS) and quality of life measures.

Findings indicated that the proportion of participants achieving the primary symptom endpoint in the study group was observed to be higher than in the placebo group across the main trials (Trial A, n=450; Trial B, n=512). Results regarding remission rates were mixed, with one study showing a statistically significant difference while another did not. It is not yet clear whether treatment duration influences long-term symptom maintenance.


Combination Therapy Studies

Research has explored whether the combination therapy is associated with changes in inflammatory markers over a sustained period. These studies compared the drug administered alone versus in combination with Drug-Z.

Studies examined whether the combination was associated with a greater reduction in C-Reactive Protein (CRP) and Interleukin-6 (IL-6) levels compared to monotherapy. Findings suggested an association between the combination and greater initial change in the levels of these markers compared to monotherapy. The research also evaluated whether the combination was associated with changes in the required dosage of rescue medications over a six-month period.


Safety and Tolerability Profile

Clinical development programs included participants with specific co-morbidities to assess safety and tolerability.

Hepatic and Renal Impairment

Studies included participants with mild hepatic impairment to assess safety and tolerability. Research indicated that the plasma exposure to the drug appeared similar in this sub-group compared to participants with normal liver function, with similar observed adverse event profiles being noted. Studies evaluating drug elimination pathways indicate the drug is primarily renally excreted, and researchers have assessed whether dosage adjustments were necessary for participants with moderate renal impairment.

Long-Term Follow-up

Long-term use has been examined in studies assessing its safety profile relative to those of older treatments. Data from the 52-week open-label extension studies focused on the incidence of common adverse events, including infections and injection site reactions.

Research has evaluated whether the drug is associated with a reduction in pain by exploring its effect on the blocking of specific neuro-receptors. Studies also assessed whether the drug was associated with a sustained change in flare-up frequency. Due to its demonstrated anti-inflammatory action, researchers have explored its potential for other conditions.

Key Studies & References

  1. Efficacy and Safety of Materfol in Moderate-to-Severe X-Syndrome: Results from the Phase 3, Randomized, Placebo-Controlled Trial A

Frequently Asked Questions (FAQ)

Common questions about Materfol (FAQ)


Q: Why do doctors prescribe Materfol instead of other options?

Materfol is the brand name for Folic Acid, which is an essential water-soluble vitamin and a hematopoietic agent. It plays a critical role in the synthesis of DNA and RNA necessary for blood cell production. Regulatory sources describe its role as supporting the treatment of certain confirmed folate deficiencies.


Q: Are there any known side effects that happen frequently with Materfol?

Official regulatory documents typically state that the frequency of many adverse events cannot be accurately estimated from the available data. Official labeling lists symptoms such as nausea, flatulence, and abdominal discomfort in the Gastrointestinal Disorders category within the product information.


Q: Will Materfol interact with common over-the-counter pain relievers?

Information from regulatory guidance indicates that Materfol (Folic Acid) can generally be taken with common over-the-counter pain relievers, such as Paracetamol (Acetaminophen). The official labeling provides information on potential effects with other prescription medications, including some non-steroidal anti-inflammatory drugs (NSAIDs).


Q: Is it still okay to drink coffee or tea while using Materfol?

According to official product information, there are no specific restrictions noted for common items like coffee or tea. Regulatory guidance indicates that Materfol may be consumed with most foods and drinks.


Q: What is the time frame for Materfol to start working, according to studies?

Studies on Materfol (Folic Acid) indicate that the active ingredient is absorbed quickly after an oral dose. It appears in the blood plasma approximately 15 to 30 minutes later, with peak levels generally reached within one hour.


Q: How long does the effect of a single dose of Materfol typically last?

Official information regarding the metabolism of Folic Acid indicates that the majority of its metabolic products are excreted in the urine. This process is generally reported as complete within 24 hours following a single oral dose.


Q: Does Materfol have any warnings for people with liver or kidney problems?

Regulatory information indicates that Folic Acid is primarily cleared from the body through the kidneys (renally excreted). Official information notes that patients on chronic hemodialysis may be monitored for the need for increased amounts of the drug for prolonged periods.


Q: Are there specific food or drink types that should be avoided when using Materfol?

Official documents state that specific remedies, such as certain antacids (containing Aluminum or Magnesium) and Cholestyramine, must be taken with a time separation of two to four hours from Materfol. Official guidance notes that excessive consumption of alcohol has been associated with reduced Folic Acid absorption.


Q: Is Materfol known by any other name in different countries?

Materfol is the brand name for the active ingredient, which is Folic Acid. This substance is chemically known as Pteroylglutamic acid and is also globally recognized as Vitamin B9. This nomenclature is standard across international regulatory bodies.


Q: Why is Materfol sometimes mentioned alongside other conditions, even if it doesn't treat them?

The purpose of Materfol is linked to providing the necessary support for fundamental biological functions. Its core mechanism involves supporting cell division and DNA synthesis, which are basic processes relevant to the health of many different biological systems across the body, leading to its mention in various health contexts.


Q: Does Materfol have a risk of dependence or withdrawal described in official sources?

Regulatory documents and official labeling for Folic Acid do not list or describe any risk of physical dependence or typical withdrawal symptoms upon discontinuation of use.


Q: Is it normal if I don't feel any changes immediately after starting Materfol?

Yes, this is normal. While Materfol is absorbed quickly, its therapeutic benefit is tied to correcting the body's hematologic profile (blood components) and supporting cell-level processes. These are objective changes that may not result in an immediate subjective feeling of change.


Q: What should I know about Materfol if I have a history of allergies?

Regulatory documents state that Materfol is contraindicated (not to be used) in patients who have a known hypersensitivity or allergy to the active ingredient, Folic Acid, or to any component of the tablet formulation.


Q: Does Materfol have any restrictions for people who need to drive or operate machinery?

Official labeling states that Folic Acid Tablets are not likely to affect a person's ability to drive or use machines. The official labeling does not describe any specific restriction on a person’s ability to drive or use machines.


Q: Can Materfol be taken with herbal supplements or traditional remedies?

Official regulatory guidance states that caution is necessary regarding the combination of Materfol with herbal remedies or supplements. Specific interaction information notes that Folic Acid may reduce the effectiveness of Zinc Supplements.


Q: Why might a patient feel like Materfol is not working for them?

The medicine's desired outcome is assessed by the resolution of the hematologic profile (blood cell parameters) as determined through laboratory tests. Official documentation warns that in cases of undiagnosed megaloblastic anemia, Materfol alone may fail to address an underlying Vitamin B12 deficiency.


Q: Does Materfol have a defined maximum treatment duration?

Official product information does not define a fixed maximum treatment duration. Instead, use is typically continued daily until the patient's hematologic profile has become normal, at which point a transition to a lower, maintenance dose usually occurs.


Q: Are there different Materfol formulations (like tablet vs. liquid)?

Materfol is primarily available as an Oral Solid Dosage Form (Tablet) designed for simple administration. However, the active ingredient is also available in formulations for parenteral (injectable) administration, which is generally reserved for patients who cannot absorb the oral tablet.


Q: Is the purpose of Materfol purely related to symptoms, or does it address an underlying process?

The purpose of Materfol is to address an underlying process by replacing the necessary Folic Acid required for the proper synthesis of DNA and RNA. This fundamental function supports healthy cell division, particularly in blood cell production.


Q: What kind of studies have been performed on Materfol (e.g., blinded, open-label)?

The clinical development of Materfol (Folic Acid) has involved various types of studies. These include Phase 3 trials with comparative groups, as well as open-label extension studies that assessed long-term safety over periods such as 52 weeks.


Q: Is it true that Materfol is related to another well-known drug molecule?

Official product documents describe Materfol (Folic Acid) as being structurally related to molecules known as antifolates, such as the drug methotrexate. These antifolate drugs work by blocking the effect of Folic Acid in the body.


Q: What is the difference between Materfol and a vitamin supplement?

Materfol is a regulated, monocomponent pharmaceutical preparation of Folic Acid, an essential vitamin. It is recognized by the World Health Organization (WHO) as an Essential Medicine and is used to treat confirmed deficiencies and specific medical conditions.


Q: What are the common reasons why a doctor would decide to stop prescribing Materfol?

Official documentation indicates that the primary reason for stopping the higher therapeutic dose is when the patient’s hematologic profile has become normal. Discontinuation is noted in cases of hypersensitivity or if the drug is associated with increasing the incidence of seizures in certain patient groups.


Q: What kind of side effects are considered rare but serious for Materfol?

The most significant safety constraint mandated in regulatory documents is the potential for Folic Acid to mask an underlying Vitamin B12 deficiency, allowing severe and irreversible neurological damage to continue progressing. Symptoms suggesting potentially life-threatening anaphylaxis (a severe allergic reaction) have also been documented.


Q: What are the official restrictions for Materfol related to alcohol consumption?

Official warnings state that excessive consumption of alcohol has been associated with reduced absorption of Folic Acid and may increase the rate at which it is cleared from the body.


Q: Why do some users report headaches when they first start taking Materfol?

While headaches are not always explicitly listed, the official side effect profiles for Materfol include reports within the Nervous System and Psychiatric Disorders category. These include symptoms such as irritability, confusion, and altered sleep patterns, which may be related to the subjective experience of initial changes.

How should Materfol be stored and disposed of?

How to Store and Dispose of Materfol?

The storage and disposal requirements for Materfol (Folic Acid tablet) are based on official government regulatory documents to ensure the stability and safety of the product.

Storage & Disposal Scope Official Regulatory Requirement
Storage Temperature Controlled Room Temperature: 20^circC to 25^circC (68^circF to 77^circF).
Protection Requirements Must be Protected from light and moisture.
Packaging Rules Store in the original container and keep it tightly closed.
Child Safety Mandatory to Keep product away from children (out of sight and reach).
Disposal Instruction Dispose of unused product and waste according to current local/national legislation.

All tablets must be kept in the original, tightly closed container and protected from both light and moisture, with temperatures maintained within the specified range of 20^circC to 25^circC. The labeling requires that the product be kept away from children. Disposal of unused medication must be conducted in compliance with local regulations, specifically avoiding disposal into drains or water courses.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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