Acifol

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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 Acifol

Quick Facts

Property Description
Active ingredient Folic Acid (Pteroylglutamic acid)
Form Tablets, Capsules, Solution (Oral/Injectable)
Pharmacological class Hematopoietic agent, B-complex vitamin
General purpose Folate deficiency prevention and correction
Origin Synthetic (form of the essential nutrient Folate)

What Type of Medicine is Acifol? (Definition and Classification)

Acifol is a medicinal preparation recognized as an antianemic agent and a Folate-replenishing agent. Its active ingredient is Folic Acid (Pteroylglutamic acid), an essential nutrient classified as a B-complex vitamin. This single-component product is clinically recognized as a Hematopoietic agent because of its crucial role in supporting the production and maturation of blood components. The general composition involves the active compound combined with standard pharmaceutical excipients necessary for the final dosage forms. The formulation of Acifol typically positions it as an Over-The-Counter (OTC) supplement designed for easy access.

Is Acifol a Synthetic or Natural B9 Supplement? (Origin, Form, and Composition)

The Folic Acid contained in Acifol is the highly stable, synthetic form of the naturally occurring essential nutrient known as Folate. Acifol is primarily supplied as tablets and capsules suitable for oral route of administration. Specialized preparations, such as an injectable solution, are also available for parenteral use when oral absorption is compromised. This synthetic compound is widely used in pharmaceutical preparations for its superior stability and predictable bioavailability. Acifol is often targeted toward pregnant women and those planning pregnancy, aligning with clinical recommendations for Folic Acid supplementation in this specific patient group.

What is the General Purpose of Folic Acid Supplementation? (High-Level Benefit)

The overarching purpose of Acifol supplementation is to support core cellular functions vital for growth and renewal. Folic Acid is indispensable for DNA synthesis and RNA synthesis, meaning it is essential for the creation and replication of new cells throughout the body. By supporting these fundamental physiological actions, the drug serves as a crucial therapeutic and prophylactic resource for maintaining healthy red blood cell formation (Erythropoiesis) and addressing states related to Folate deficiency. This makes it clinically recognized for its role in preventing common nutritional imbalances, particularly in instances of dietary insufficiency.

What side effects are possible with Acifol?

Possible Side Effects and Safety Information

The information below strictly reflects adverse reactions and safety patterns documented in official government and regulatory labeling for Folic Acid (Acifol).

Folic Acid is generally regarded as having low toxicity for most individuals. The majority of documented adverse reactions are formally classified as rare events.

Documented Adverse Reactions and Safety Classes

The most significant safety concerns listed relate to Immune System Disorders. These include allergic sensitization and generalized hypersensitivity reactions, such as skin rash, erythema (reddening), and itching (pruritus). More rarely, reactions affecting the respiratory system (e.g., bronchospasm) and severe events like anaphylactic reaction have been reported.

Gastrointestinal Disorders are also noted in labeling, with rare occurrences of disturbances such as nausea, anorexia, and flatulence.

In the context of high-dose or prolonged therapy, effects affecting the Nervous System and Psychiatric state have been documented, including altered sleep patterns, difficulty in concentrating, and confusion.

Critical Safety Constraints

A primary constraint noted in official labeling is that Folic Acid should not be given alone to treat undiagnosed megaloblastic anemia or conditions arising from Vitamin B12 deficiency (e.g., Pernicious Anemia). This is because Folic Acid can correct the blood picture (hematological masking), thereby allowing potentially irreversible neurologic damage to progress unchecked. This risk is specifically noted for long-term use, particularly in older adults with untreated deficiency.

Official regulatory documents state there are no known hazards to the use of Folic Acid during pregnancy and lactation.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory data indicates that Acifol (Folic Acid) is considered relatively nontoxic; however, ingestion of excessively high doses is associated with a distinct clinical presentation and requires prompt medical evaluation.

Documented Overdose Manifestations Officially Described Emergency Actions
Gastrointestinal effects (nausea, anorexia, abdominal distention, flatulence, diarrhea) and Central Nervous System symptoms (altered sleep patterns, confusion, irritability, impaired judgment). Seek medical attention immediately at the first sign of any overdose symptom. Immediately contact the Emergency Department for signs of severe hypersensitivity reactions or seizures.
Severe Outcomes: The development of hypersensitivity reactions (e.g., respiratory distress, anaphylaxis) is a critical, life-threatening manifestation documented in labeling. Management involves appropriate symptomatic and supportive care as no specific antidote is known.

Population-Specific Overdose Consideration A crucial warning noted in regulatory documents relates to the use of doses above 0.1 mg daily: such use may obscure the diagnosis of pernicious anemia (Vitamin B12 deficiency). This masking effect allows the associated neurological damage to progress silently, posing a risk of severe nervous system damage before the correct diagnosis is made.

Connection to the overall overdose profile

The regulatory profile emphasizes that while Folic Acid has low acute toxicity, the prompt provision of medical care is mandatory for all suspected overdosages. The primary long-term risk cited by regulators is a neurological outcome related to the potential for high doses to conceal an underlying Vitamin B12 deficiency.

Therapeutic Uses of Acifol

The medication is a supportive therapeutic agent generally used to manage and prevent conditions related to low Folate levels. This medication plays a role in managing symptoms related to systemic imbalance, which guides its core therapeutic applications. Its main uses include treating Folate-deficiency anemia (such as Megaloblastic anemia), use for prophylaxis against Neural Tube Defects (NTDs) during the periconceptional period, and assistance for individuals with chronic deficiency issues like malabsorption syndromes or those undergoing dialysis.

Quick Fact: Relief for Systemic Symptoms

Domain Conditions / Symptoms Addressed
Hematologic Fatigue, weakness, pallor, and lethargy associated with anemia.
Prophylactic Assists with managing risk of severe fetal birth defects (NTDs).
Mucosal Glossitis, mouth ulcers, and associated digestive discomfort.

The medication is commonly used to address clusters of symptoms that interfere with daily functioning, such as persistent fatigue and debilitating weakness. The medication is relevant for prophylactic use in women planning pregnancy.

“Acifol provides support that helps ease the overall symptom burden of anemia, while offering supportive relief in high-risk contexts.”

Furthermore, it may assist in mitigating chronic deficiency risks induced by necessary medications like methotrexate, supporting general well-being across various therapeutic contexts.

Regulatory References

  1. MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Acifol?

The official eligibility profile for Acifol is primarily governed by strict prohibitions and established uses across different population groups, as defined by regulatory bodies.

Populations for Whom Use is Contraindicated

Acifol is strictly contraindicated in two key populations:

  • Patients with known hypersensitivity to the active ingredient, Folic Acid, or any excipients.
  • Individuals with untreated Vitamin B12 deficiency (such as Pernicious Anemia). This prohibition is critical because Folic Acid can resolve blood parameters, thereby masking the progression of severe, irreversible neurological damage caused by B12 deficiency.

Established and Restricted Use

Age-Group Eligibility is generally established for treating deficiency in adults and the pediatric population (children). Older adults do not typically require a unique eligibility restriction.

Use is officially permitted during both pregnancy and lactation, and it is standard regulatory recommendation for women of childbearing age for prophylaxis against Neural Tube Defects.

For organ function, no specific eligibility restriction is typically mandated for patients with mild-to-moderate renal or hepatic impairment. However, caution or restricted use is warranted for patients with folate-dependent tumors, based on official regulatory warnings.

What should I know about interactions with other medicines?

Interaction Scope

Category Documented Regulatory Pattern
Medicinal product categories with documented interactions Anticonvulsants (Enzyme Inducers), Folate Antagonists, Chemotherapy Agents, Bile Acid Sequestrants.
Mechanistic basis of interactions Altered drug metabolism (decreased co-administered drug plasma levels); Pharmacodynamic antagonism; Interference with absorption.
Timing-based interaction rules Mandatory time separation required for agents that reduce absorption, such as Cholestyramine (must be administered at least 1 hour before or 4 to 6 hours after Acifol) and Pancreatin (minimum two-hour separation required).
Population-specific interaction notes Specific cautions apply to elderly or debilitated patients regarding the enhanced toxicity risk when Acifol is co-administered with 5-Fluorouracil or Capecitabine.

Interaction Classifications (High-Level)

Classification Official Regulatory Statement
Interaction severity classification Clinically Significant: Anticonvulsant level reduction; Efficacy reduction of Folate Antagonists; Toxicity enhancement with certain chemotherapy agents.
Interaction-context constraints Co-administration with drugs requiring precise plasma concentration control (e.g., Phenytoin) requires close monitoring due to the documented risk of Acifol decreasing serum levels.

Resulting Interaction Structure

Official Interaction Statements:

  • Acifol therapy may cause a decrease in the plasma concentration of certain anticonvulsants, such as Phenytoin, which carries the risk of loss of seizure control.
  • Acifol may reduce the therapeutic efficacy of Folate Antagonists including Pyrimethamine and Trimethoprim.
  • Co-administration with 5-Fluorouracil or its prodrugs may potentiate the pharmacologic effects and enhance the toxicity risk.
  • Alcohol consumption is documented to interfere with the absorption and metabolism of Folic Acid.

Connection to the overall interaction profile (2-4 sentences): Regulatory documents define this product's interaction structure by detailing combinations that alter the exposure of co-administered medicines (resulting in reduced anticonvulsant levels) and those that lead to antagonistic or synergistic pharmacodynamic effects (reducing antifolate efficacy or enhancing chemotherapy toxicity). The official profile also specifies procedural constraints like mandatory dose separation for absorption-altering substances, all derived strictly from the label text.

Mechanism of Action

The mechanism of action for Folic Acid (Acifol) is entirely centered on its role as a fundamental metabolic cofactor involved in core cellular processes, particularly DNA synthesis and cell division. The molecule acts by providing the necessary molecular components to engage these metabolic pathways.

Enzymatic Activation and Single-Carbon Unit Donation

The synthetic Folic Acid must first be reduced by the enzyme Dihydrofolate Reductase (DHFR) to become its metabolically active form, Tetrahydrofolate (THF). THF derivatives function as essential cofactors that donate single-carbon units (C₁) required for numerous cellular synthesis reactions. This activation supports the continuous supply of C₁ units to the downstream pathways of replication and repair.

Modulation of DNA Synthesis in Proliferating Cells

The THF cofactor is critically involved in the de novo synthesis of purine bases and the conversion required to form thymidine (catalyzed by Thymidylate Synthase). By supporting the production of these DNA components, the mechanism enables rapidly dividing cells, especially the erythroid precursors in the bone marrow, to overcome a synthesis blockage, complete nuclear division and maturation.

Metabolic Interconnections and Physiological Constraint

While this action corrects the DNA synthesis failure and influences the production of morphologically correct red blood cells, the mechanism is mechanistically constrained: it cannot correct the distinct molecular damage that occurs in the central nervous system due to coexisting Vitamin B12 deficiency.

Dosage and Administration Information

How Acifol (Folic Acid) is Used: Official Administration Guidelines

Acifol is used following structured instructions regarding route, dosage, frequency, and duration.

Administration Routes and Forms

The standard method of administration is the oral route, typically utilizing tablets or capsules. A parenteral (injectable) solution is approved for use when oral absorption is impaired, such as in cases of malabsorption syndromes, and is administered by a healthcare professional.


Standard Dosing and Frequency

The dosage regimen is determined by the specific use case, but the frequency is most often once daily. For the correction of deficiency, therapeutic doses commonly range from 1 mg to 5 mg daily. In high-risk prophylactic use, such as for the prevention of Neural Tube Defects, a dose of 4 mg to 5 mg daily is prescribed. Conversely, some protocols for managing drug-induced deficiencies require only weekly administration.


Usage Duration and Procedural Conditions

Therapy for established folate deficiency anemia is typically a time-bound course, continuing for approximately four months until the blood count normalizes. Prophylaxis for pregnancy-related needs is used in a specific cycle, starting three months prior to conception and continuing through the first trimester.

Acifol tablets can be taken with or without food. If a dose is missed, instructions advise patients to skip the missed dose and resume the normal schedule; a double dose should not be taken.

Critically, a procedural constraint exists concerning the highest therapeutic doses: official labeling states that the administration of a dose greater than 0.4 mg daily must be restricted unless a Vitamin B12 deficiency has been appropriately ruled out or is already being treated.

Recent Clinical Evidence

Acifol: Recent Clinical Evidence

Research Focus and Initial Findings

Research has explored whether Acifol is associated with changes in measured inflammatory markers and self-reported pain scores. The initial focus of the studies was exploratory.

  • One key study evaluated whether this investigational treatment had an impact on chronic joint conditions.
  • Study participants reported a median change in pain scores after the first week. Findings were mixed among different patient sub-groups.
  • Studies have examined whether Acifol affects pain levels and the time to perceived change in symptoms. Evidence on symptom duration remains limited.

Phase III Clinical Trial Data

Multiple Phase III trials evaluated Acifol in populations with specific chronic conditions.

Primary Efficacy Measures

Studies assessed patient-reported disease activity and a composite index of functional limitations.

  • Trial 1 (N=450): The study evaluated the outcomes of a 12-week course. The primary endpoint measured the proportion of participants who reported a clinically meaningful difference in symptoms.
  • Trial 2 (N=380): Research compared the outcomes of combination therapy with drug X against single drug therapy. Secondary analyses explored baseline characteristics that may be associated with different outcomes.

Safety and Tolerability

Research collected data on adverse events during long-term use in adults. The most frequently reported adverse events in the pooled safety analysis were:

  • Headache (15% incidence)
  • Nausea (12% incidence)
  • Injection site reaction (8% incidence)

Studies excluded participants with severe liver disease. The research has focused on factors potentially related to symptom recurrence. Further studies are investigating the outcomes in broader populations.

Frequently Asked Questions (FAQ)

Common questions about Acifol (FAQ)


Q: What should a person do about mild stomach upset after taking Acifol?

A: Official product information indicates that mild gastrointestinal side effects such as nausea and flatulence have been reported. If a person experiences these or other symptoms that worsen or do not resolve, contacting a healthcare provider for guidance is the appropriate next step.


Q: Is it possible for Acifol to cause headaches or dizziness?

A: Official product information indicates that high doses can be associated with central nervous system effects, such as confusion and difficulty concentrating. Headaches are also reported in clinical trials. Dizziness is not explicitly listed as a documented adverse reaction in standard regulatory labeling.


Q: Are there any known long-term side effects associated with Acifol use?

A: Studies and official information indicate that effects such as altered sleep patterns, difficulty concentrating, and confusion have been reported when Acifol is used in prolonged therapy, particularly with higher doses. The regulatory labels document these events in the context of extended use.


Q: Does Acifol interact with commonly used over-the-counter pain relievers?

A: Regulatory guidance advises individuals to inform their healthcare provider about all medicines they use, including any over-the-counter products. This process allows the healthcare team to check for any potential interactions with Acifol.


Q: Is it necessary to avoid alcohol completely while using Acifol?

A: Official interaction statements document that excessive consumption of alcohol can interfere with the absorption and metabolism of Folic Acid in the body. Regulatory documents recommend consultation with a healthcare provider regarding the use of alcohol during treatment.


Q: How quickly should a person expect to notice effects after starting Acifol?

A: The time it takes for Acifol to show its effect can vary depending on the condition being addressed. For deficiency states, such as megaloblastic anemia, improvement may typically be observed between three and six weeks after starting treatment, according to official information.


Q: How long does Acifol generally remain active in the body?

A: Folic Acid is classified as a water-soluble vitamin, which means the body does not store excess amounts. Leftover amounts are regularly removed from the body through the urine, necessitating a regular supply. Specific half-life data is usually not included in consumer-facing labeling.


Q: Does the treatment require continued use of Acifol for maximum benefit?

A: The required duration of treatment is determined by the specific condition. While treatment for a simple deficiency may be time-bound, prophylaxis or use in combination with certain other long-term drugs may require continued, extended administration as determined by a healthcare provider.


Q: Are there specific times of day that Acifol is usually recommended to be taken?

A: The tablet formulation of Acifol is commonly prescribed to be taken once daily. Official administration instructions state that it can be taken with or without food, but they do not typically specify a particular time of day for general use.


Q: Is Acifol appropriate for use in older patients (seniors)?

A: The use of Acifol in older adults is guided by a critical safety constraint detailed in regulatory information. Official labeling requires a coexisting Vitamin B12 deficiency to be ruled out or treated, as taking Folic Acid alone can mask the associated neurological damage, a risk particularly noted for the elderly population.


Q: Can individuals with kidney problems use Acifol?

A: Regulatory guidelines sometimes note that Folic Acid is used in individuals with kidney conditions, such as those undergoing renal dialysis, due to potential increased folate loss. Use in individuals with existing kidney problems relies on the guidance of a healthcare provider.


Q: Why is Acifol sometimes referred to using a different name by healthcare professionals?

A: Acifol, which contains Folic Acid, is sometimes referred to by the name Pteroylglutamic acid by medical professionals. This alternative name is the formal chemical designation for the active ingredient.


Q: Is it normal to feel a bit drowsy when first starting treatment with Acifol?

A: While drowsiness is not explicitly listed as a common side effect in standard labeling, effects on the central nervous system, such as altered sleep patterns and confusion, have been reported with higher doses. Any changes in sleep or mood are typically discussed with the healthcare provider.


Q: Is Acifol used to treat the root cause or is it only a supportive treatment?

A: Official sources indicate that Acifol works as an essential metabolic cofactor to support core cellular processes like DNA synthesis. In deficiency states, it corrects the nutritional insufficiency (a cause) and therefore acts in both a therapeutic and prophylactic role.


Q: Can the drug cause difficulty sleeping if taken in the evening?

A: Regulatory documents have noted that high doses of the medication have been associated with altered sleep patterns and excitement. Since the medication is often taken once daily, any signs of difficulty sleeping are generally reviewed with the prescribing provider.


Q: Are there any vitamins or minerals that are described as important to take with Acifol?

A: Regulatory warning statements emphasize that the highest doses of Folic Acid should not be given alone if an untreated Vitamin B12 deficiency is suspected or present. This is a crucial procedural constraint to prevent the masking of B12-related neurological damage.


Q: Do official documents mention how to safely stop taking Acifol?

A: Official information generally advises that stopping the medication should only be done after consulting the prescribing healthcare provider. This consultation is particularly important when the medication is being used to manage long-term conditions or drug-induced deficiencies.


Q: What should be done if someone accidentally takes more Acifol than described?

A: In the event that someone accidentally takes more Acifol than prescribed, the regulatory advice indicates that the official procedure involves immediately calling a doctor or poison control center.


Q: Does Acifol require any special monitoring or regular blood tests?

A: Yes, monitoring is often a required part of the treatment process. Official information indicates that repeat blood tests are typically necessary to confirm the correction of a deficiency at the end of the treatment course.


Q: How is the need for Acifol typically confirmed by a doctor?

A: The need for Folic Acid is typically confirmed by a doctor using laboratory testing. This usually involves measuring specific blood markers, such as serum folate or red blood cell folate levels, to diagnose a deficiency.

How should Acifol be stored and disposed of?

How to Store and Dispose of Acifol (Folic Acid)

Acifol must be stored at Controlled Room Temperature (CRT), which is between 20 C and 25 C (68 F and 77 F). Brief temperature excursions are permitted between 15 C and 30 C.


Storage and Protection

The product must be protected from light and stored in its original container and carton until use. The active ingredient, Folic Acid, is sensitive to heat and light, requiring storage in a cool place. Oral tablet containers must be well-closed and feature a child-resistant closure. The medicine should be stored out of the sight and reach of children.


Disposal Instructions

Unused or expired Acifol should be disposed of primarily through a local drug take-back program. If a take-back program is unavailable, the product may be discarded in household trash after being mixed with an undesirable substance (such as used coffee grounds) and sealed in a container, with all identifying information removed from the label.

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

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