Andreafol

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Medically reviewed

Laura Arias

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 Andreafol

What is Andreafol?

Andreafol is a medicinal preparation containing folic acid, which is a water-soluble vitamin belonging to the B-complex group (specifically vitamin B9). Folic acid is an essential nutrient that the human body cannot produce on its own in sufficient quantities, meaning it must be obtained through diet or supplementation.

Role in the Body

Folic acid plays a fundamental role in several vital biological processes. It is primarily involved in:

  • Cell Division: It is necessary for the synthesis of DNA and RNA, the genetic material of cells. This makes it crucial for the growth and repair of all tissues.
  • Blood Formation: It contributes to the production of red blood cells in the bone marrow, helping to prevent certain types of anemia.
  • Metabolism: It assists in the metabolism of amino acids, the building blocks of proteins.

Use During Pregnancy

One of the most common applications of Andreafol is in the context of pregnancy and family planning. During the early stages of fetal development, folic acid is critical for the proper formation of the neural tube, which eventually develops into the brain and spinal cord. Adequate levels of this vitamin are necessary to support the rapid cell division occurring during embryonic growth.

Regulatory References

  1. Folic Acid - MedlinePlus

What side effects are possible with Andreafol?

Possible Side Effects and Safety Information

This section outlines the adverse reactions and essential safety restrictions for Andreafol (Folic Acid) as documented in official government regulatory documents (such as the FDA Prescribing Information and European Summary of Product Characteristics).

Critical Safety Restriction

The most important safety limitation for Folic Acid is its contraindication in patients with undiagnosed or untreated Vitamin B12 deficiency (e.g., pernicious anemia). This restriction exists because Folic Acid can correct the blood abnormalities of B12 deficiency (hematologic remission) while allowing potentially irreversible neurological damage to continue or worsen. Folic Acid must not be used as monotherapy in this setting.

Documented Adverse Reactions

Official documents classify most side effects as Rare or their frequency as Not Known. Reactions are grouped by system-organ class:

System/Organ Class Documented Adverse Reactions (Rare/Not Known)
Immune System / Skin Hypersensitivity reactions (e.g., rash, pruritus, urticaria, erythema). Severe reactions, including anaphylactic shock, are documented.
Gastrointestinal Anorexia, nausea, abdominal distension, flatulence.

Population and Exposure Safety Notes

  • Epileptic Patients: Safety information notes that Folic Acid may decrease the concentration of certain anti-seizure medicines, which could present a risk for loss of seizure control.
  • Long-Term/High-Dose Use: Neurological and psychiatric effects (e.g., impaired judgment, agitation, altered sleep patterns) have been associated with chronic administration of very high doses of Folic Acid.
  • Pregnant and Lactating Women: Official safety documentation states there are no known hazards associated with the use of Folic Acid for deficiency treatment or structural defect prevention during pregnancy and lactation.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — Official Regulatory Information for Andreafol

Feature Official Regulatory Statement
Documented overdose presentations Primarily non-specific gastrointestinal disturbances (e.g., nausea, flatulence) and CNS effects (e.g., irritability, altered sleep patterns), typically associated with prolonged, high-dose intake.
Physiological systems affected (as stated in label) Gastrointestinal system and Central Nervous System (CNS). Rare instances of severe allergic sensitization (e.g., anaphylactic reaction).
Emergency-response statements (as written in official documents) No specific antidote is known. Management is based on symptomatic and supportive treatment and product withdrawal.
When immediate medical help is required (label-derived phrasing only) Seek immediate medical attention for any suspected overdose or immediately contact a poison control center.
Classification Feature Official Regulatory Statement
Severity classification (as defined in official documents) The substance is characterized by low acute intrinsic toxicity, with excess amounts generally eliminated via renal excretion.
Overdose-context constraints (as defined in official documents) Clinical observation is required. Procedural measures like gastric lavage or activated charcoal may be considered for massive, recent ingestions.

Resulting overdose structure

Official overdose statements:

  • Overdose manifestations are non-specific and generally mild, including gastrointestinal and CNS effects, as described in regulatory documents.
  • No specific antidote is known for Folic acid overdose, making symptomatic and supportive treatment the mandated management approach.
  • High intake levels may obscure the blood picture of underlying Vitamin B12 deficiency, a critical regulatory warning associated with high-dose use.
  • The regulator requires all individuals to seek immediate medical attention for any suspected overdose.

Connection to the overall overdose profile (2–4 sentences): Regulatory documents define the overdose profile by the drug's low acute intrinsic toxicity, meaning the primary focus is not on acute organ damage from the substance itself. This profile mandates that the management strategy focuses on product discontinuation and clinical observation, underscoring the regulator's requirement to seek immediate medical attention to manage non-specific symptoms and confirm exclusion of rare severe hypersensitivity events.

Therapeutic Uses of Andreafol

Andreafol: Main Uses and Therapeutic Benefits

Andreafol (Folic acid) may be part of symptomatic management for specific types of megaloblastic and macrocytic anemias that result from a lack of folate. By addressing the deficiency, it may assist with managing symptoms related to systemic imbalance, such as profound fatigue and physical weakness, which contributes to improved day-to-day comfort during symptomatic periods.


It is considered relevant in the context of preconception care and early pregnancy support for women of childbearing age. The medication is commonly used to help with the increased folate need and may assist with maintaining nutritional support relevant to the reduction of risk for serious structural birth defects, specifically Neural Tube Defects (NTDs) like spina bifida and anencephaly. This preparation is also relevant for easing the discomfort of painful glossitis (swollen tongue) and persistent mouth ulcers, which are manifestations of this specific deficiency.


“This support is relevant for easing symptoms that interfere with routine daily life when caused by specific nutritional deficiencies.”

Quick Fact: Support for Managing Systemic Fatigue Andreafol is relevant for easing fatigue and weakness that accompany folate-deficient anemia, which helps maintain a sense of stability when symptoms are more noticeable.

Eligibility and Restrictions for Use

Who can and cannot use Andreafol?

Populations for Whom Use is Contraindicated

Andreafol (Folic Acid) must not be used by individuals with a known hypersensitivity to the drug or its components. The most critical restriction is for patients with undiagnosed megaloblastic anemia or pernicious anemia caused by an untreated Vitamin B12 deficiency. Using Andreafol alone in this circumstance is considered improper therapy and is contraindicated because it can correct the blood deficiency while allowing potentially irreversible neurological damage to progress unnoticed. The medicine is also typically contraindicated in patients with malignant diseases, unless the anemia is definitively confirmed to be due to folate deficiency.

Age and Special Population Eligibility

The use of Andreafol is broadly permitted for adults and children, regardless of age, when treating documented folate deficiency. It is explicitly indicated and permitted for use during pregnancy and lactation, often classified as safe and necessary. For older adults starting long-term treatment, testing for potential Vitamin B12 deficiency may be necessary as a precaution. Furthermore, patients with rare hereditary conditions such as lactose or galactose malabsorption should not use the standard tablet formulation due to excipients.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Andreafol (Folic acid) interactions are officially documented across several domains, primarily involving antagonism of co-administered medicines and modification of plasma drug levels. The regulatory profile identifies the risk of pharmacodynamic antagonism with anticonvulsant agents, including Phenytoin, Phenobarbital, and Primidone. Folic acid is documented to decrease the plasma concentration of these anticonvulsants by increasing the rate of their breakdown. Similarly, Folic acid may decrease the therapeutic effect of antimetabolite agents like Methotrexate and Pyrimethamine, and may increase certain side effects when co-administered with chemotherapy agents.

A critical restriction in official labeling concerns undiagnosed megaloblastic anemia stemming from Vitamin B12 deficiency. Folic acid administration is designated as improper therapy in this context, as it may correct the blood cell abnormalities while allowing irreversible neurological damage to progress unchecked.

Regarding administration constraints, regulatory documents specify a mandatory time separation with Antacids that contain Aluminium or Magnesium. To prevent reduced Folic acid absorption, Andreafol must not be taken within 2 hours before or after these antacids. Furthermore, chronic alcohol consumption is documented to interfere with folate metabolism and absorption.

Mechanism of Action

How Andreafol Works

Andreafol is a small molecule that acts as a competitive antagonist at the Osteoclast Differentiation Factor (ODF) receptor. The compound binds with high affinity to the extracellular ligand-binding domain of the receptor, modulating ODF-mediated signaling. This binding event prevents the dimerization and subsequent activation of the ODF receptor, thereby inhibiting the canonical NF-κB pathway activation cascade. This suppression immediately affects the transcription of essential genes, such as Cathepsin K, which are required for the differentiation and maturation of osteoclasts. This targeted action shifts the balance of bone remodeling toward the formation phase, resulting in a net decrease in the rate of bone resorption.

Dosage and Administration Information

This section outlines the administration and dosing guidelines for products containing Folic Acid or Calcium Folinate (Leucovorin), which are the active components of Andreafol. These instructions are provided for informational purposes and do not constitute medical advice.

Administration Scope

Instruction Category General Guidelines
Route of Administration Oral (PO) administration is generally preferred and well-absorbed; however, Intravenous (IV), Intramuscular (IM), and Subcutaneous (SC) injection routes are utilized for cases of malabsorption or when parenteral use is necessary.
Dosing Schedule Standard Dose: For general deficiency, usual therapeutic adult dosing is up to 1.0 mg daily. High-Dose/Regimen-Specific: For certain conditions, doses of 5 mg or higher daily may be required. Calcium Folinate rescue is typically administered in regimens such as 15 mg (or 10 mg/m^2) every six hours.
Timing in Relation to Meals Oral tablets may be administered with or without food.
Age-Group Rules The daily maintenance dose is differentiated by age: 0.1 mg for infants, up to 0.3 mg for children under 4 years, and 0.4 mg for adults and children 4 years and older. Higher doses are specified for pregnant women with a history of certain conditions.
Missed-Dose Rules If a dose is missed, patients should skip the missed dose and resume the regular schedule, without taking a double dose to compensate.
Special Procedural Conditions The solution for injection must not be administered intrathecally. IV injection should not exceed a rate of 160 mg per minute.

Resulting Procedural Structure

The instructions establish a structured protocol that begins with selecting the appropriate dosage form (tablet or solution). The patient must then adhere to the dose amount and frequency specified by the regimen (daily, weekly, or several times a day), which may be modified based on specific age or medical status. Parenteral administration is reserved only for specific circumstances where oral intake is not feasible, and must follow rules regarding dilution and injection rate.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Andreafol (Folic Acid)

Evidence for Use in Correcting Folate-Deficiency Anemia

Research involving Andreafol (Folic acid) has been used in studies exploring patient populations presenting with anemias that are related to a lack of folate. The evidence for this use is derived from systematic reviews and documentation of clinical observations. These evaluations focused on patient populations presenting with megaloblastic anemia. Researchers primarily monitored outcomes related to systemic imbalance, such as shifts in blood counts and patterns related to systemic symptoms. Findings describe patterns observed in the studies related to generalized physical discomfort and weakness when the supplement was introduced. The research base contributes to understanding symptom patterns and reflects a well-characterized evidence level due to the long-standing understanding of the physiological role of folate in the blood disorder.

Evidence for Preventing Neural Tube Defects (NTDs)

The research examining Andreafol for the prevention of Neural Tube Defects (NTDs) was studied in outcomes related to acute episodes. The foundation of the evidence comes from large-scale randomized controlled trials (RCTs) that studied recurrence in high-risk populations—specifically, women who had a previous pregnancy affected by an NTD. Research describes patterns related to fewer occurrences of NTD recurrence in the high-risk groups observed in the studies. This evidence was also evaluated in broader observational settings, including population-level studies derived from mandatory food fortification programs. Findings indicate patterns related to the observed rate of these birth defects in the general population of women of childbearing age. The outcomes of the RCTs provided the scientific context for broad public health guidelines.

Frequently Asked Questions (FAQ)

Common questions about Andreafol (FAQ)

Q: What is the main reason Andreafol is prescribed?

According to official regulatory documents, Andreafol is indicated for treating megaloblastic anemias that are caused by a lack of folic acid. Additionally, the compound is studied for its role in preventing neural tube defects during pregnancy. This information highlights its essential role in supporting healthy blood formation and development.

Q: Does Andreafol start working immediately after the first use?

Official pharmacological data indicates that the active ingredient is rapidly absorbed from the small intestine into the bloodstream. Following an oral dose, the substance typically appears in the plasma (blood) within 15 to 30 minutes. This indicates rapid entry into the system, although official documents do not describe the physical effect a person might feel.

Q: How long does it usually take to notice the effects of Andreafol?

Regulatory information confirms that the active ingredient is rapidly absorbed into the bloodstream within 15 to 30 minutes of taking a dose. However, official drug labels do not specify the time required for a patient to observe or feel the visible clinical effects of the treatment.

Q: What are the most common things people feel when they first start taking Andreafol?

Official regulatory labeling does not define a list of common or expected feelings when beginning this medication. Documented adverse reactions are generally classified as rare, but some reports have included general discomfort, weakness, skin rash, or itching.

Q: Is there a generic version of Andreafol available?

The active ingredient in Andreafol is Folic Acid. Regulatory records indicate that this compound is available under various generic and brand names, including standard tablet strengths.

Q: Can Andreafol impact the results of laboratory tests?

Official drug precautions note that Andreafol can potentially interfere with certain laboratory results. Specifically, it may lead to false low readings for serum and red cell folate levels if a patient is simultaneously taking specific antibiotics, such as tetracycline.

Q: Is it acceptable to crush or chew Andreafol tablets?

Official product labeling for oral tablets often specifies if a tablet can be altered before swallowing. If the regulatory documents do not provide explicit instructions that permit crushing or chewing, the product is typically administered by swallowing the tablet whole as manufactured.

Q: Does Andreafol carry any 'Black Box' warnings in the US?

While official labeling for Folic Acid includes a critical safety restriction regarding the risk of masking Vitamin B12 deficiency, the official FDA label does not contain a specific 'Boxed Warning' (commonly referred to as a Black Box warning). The critical safety restriction regarding B12 deficiency is noted as essential in the regulatory information.

Q: How long after stopping Andreafol does it stay in the system?

According to pharmacokinetic information provided in official documents, most of the metabolic products of the active ingredient are excreted through the urine. This excretion process is typically complete within 24 hours following the administration of an oral dose.

Q: How can I find the official prescribing information for Andreafol?

Official and comprehensive prescribing information can be located on the websites of government drug regulators. This includes the FDA’s DailyMed in the United States, the Summary of Product Characteristics (SmPC) from the European Medicines Agency (EMA), and similar sources from agencies like Health Canada.

How should Andreafol be stored and disposed of?

How to Store and Dispose of Andreafol

The storage and disposal of Andreafol (Folic Acid) must comply strictly with the conditions defined in the official regulatory labeling to maintain product stability and ensure proper handling.

Required Storage Conditions

Andreafol must be stored out of the sight and reach of children. The product must not be stored above 25 C and must be kept in the original container to protect from light.

Storage Factor Regulatory Requirement
Temperature Do not store above 25 C
Protection Keep in original container to protect from light
Child Safety Keep out of the sight and reach of children

Disposal Instructions

Unused or expired Andreafol must not be thrown away via wastewater or household waste. The medicine should be returned to the pharmacist for safe disposal according to local requirements, as these measures are intended to help protect the environment.

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

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