Фансидар

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Фансидар

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Treatment option: Malaria, Malaria Prevention

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 Фансидар

Property Description
Active Ingredients Sulfadoxine, Pyrimethamine
Form Oral Tablets
Pharmacological Class Antimalarial, Anti-infective Combination
General Purpose To halt parasitic multiplication in the bloodstream
Origin Synthetic Chemical Compounds

What is Фансидар and What Type of Medicine Is It?

Фансидар is the widely recognized trade name for the generic fixed-dose combination drug known as Sulfadoxine-Pyrimethamine, which is classified as an antimalarial combination and a powerful synthetic anti-infective agent. This medication is designed for use against specific parasitic protozoa. It maintains a recognized role in global public health and this combined formulation is clinically recognized for its utility in managing acute episodes of specific parasitic diseases.

Composition and Form of Sulfadoxine-Pyrimethamine

The composition is defined by its two principal active ingredients: Sulfadoxine and Pyrimethamine. Sulfadoxine is a sulfonamide antibiotic, while Pyrimethamine is an antifolate agent. The fixed-dose combination approach is utilized to ensure reliable drug ratios for treatment efficacy. The medicine is supplied for the oral route of administration, typically in the form of tablets.

General Purpose and Synergistic Action

The general purpose of Sulfadoxine-Pyrimethamine is to achieve blood schizonticidal activity, meaning it targets and destroys the parasites as they multiply within the bloodstream. The drug's therapeutic value relies on a powerful synergistic mechanism, which is its core principle of action. This synergy is achieved because the ingredients execute a sequential, critical blockade in the parasite's metabolism: Pyrimethamine inhibits one enzyme, and Sulfadoxine inhibits another. By disrupting the parasite's essential folic acid biosynthesis pathway, the combination is significantly more potent than either drug used in isolation, stopping the parasite's ability to reproduce.

What side effects are possible with Фансидар?

Possible Side Effects and Safety Information

The use of Fansidar (Sulfadoxine/Pyrimethamine) is associated with a risk of severe, potentially fatal adverse reactions, particularly within the dermatologic and hematologic system organ classes. These risks necessitate strict adherence to safety guidelines based on regulatory documents.

Serious and Clinically Significant Adverse Reactions

System-Organ Class Serious Adverse Reactions (Examples)
Skin and Subcutaneous Tissue Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Exfoliative Dermatitis, Fatalities
Blood and Lymphatic System Agranulocytosis, Aplastic Anemia, Megaloblastic Anemia, Severe Thrombocytopenia
Hepatobiliary Disorders Fulminant Hepatic Necrosis, Hepatitis, Liver Enzyme Elevations
Renal and Urinary Disorders Toxic Nephrosis with oliguria and anuria, Renal Failure, Crystalluria

Serious reactions are considered rare, but fatalities have been reported, primarily due to severe hypersensitivity events (SJS/TEN). Hematologic toxicity, such as leukopenia, has been reported with extended prophylactic use (two months or longer) and may be dose-related.

Contraindications and Safety Limitations

Fansidar is contraindicated in patients with a history of hypersensitivity to pyrimethamine, sulfonamides, or any component of the drug. It is also contraindicated in patients with documented megaloblastic anemia due to folate deficiency, infants less than two months of age, and for prophylactic use during late pregnancy and the nursing period. Repeated prophylactic use is further restricted in patients with renal or hepatic failure or pre-existing blood dyscrasias.

Safety Monitoring and Restrictions

  • Immediate Drug Discontinuation is mandatory at the first appearance of a skin rash, any significant reduction in blood element counts (cytopenia), or the occurrence of an active bacterial or fungal superinfection.
  • Caution is advised in patients with impaired renal or hepatic function, glucose-6-phosphate dehydrogenase (G6PD) deficiency (due to potential hemolysis), and possible folate deficiency.
  • Adequate fluid intake must be maintained to minimize the risk of crystalluria and stone formation, and excessive sun exposure must be avoided.

Overdose and Emergency Response

Overdose and when to seek help

Overdose may present with severe initial signs primarily involving the gastrointestinal system, such as severe and repeated vomiting, abdominal pain, and potential hematemesis (vomiting blood). More critical manifestations involve the Central Nervous System (CNS), which can rapidly progress from initial excitability to generalized and prolonged convulsions (seizures). Other severe outcomes documented in regulatory prescribing information include respiratory depression and circulatory collapse, carrying a documented risk of death.

Immediate medical attention must be sought if overdose is suspected due to the rapid onset of potentially fatal neurological events. The regulatory profile notes that no specific antidote is known for Pyrimethamine toxicity. Therefore, management is defined as symptomatic and supportive, including procedures like gastric lavage and the administration of agents such as parenteral diazepam to control seizures, and Folinic acid (leucovorin).

A specific consideration is that infants and children are explicitly documented as extremely susceptible to the adverse effects of an overdose. Furthermore, regulatory documents mandate that post-overdose management requires daily monitoring of peripheral blood counts for an extended period of several weeks until normal values are restored, reflecting the potential for delayed blood dyscrasia.

Therapeutic Uses of Фансидар

What Фансидар Treats: Main Uses and Benefits

The primary therapeutic role of Фансидар (Sulfadoxine-Pyrimethamine) is focused on addressing the parasitic disease malaria, particularly infections caused by drug-resistant Plasmodium falciparum. This combination is recognized within global health strategies for addressing acute infections and offering protective support in high-risk patient groups.

The medication is commonly used to help with symptoms related to systemic imbalance during an acute episode, such as fever, chills, and headache. It is also applied in chemoprevention programs for pregnant women (Intermittent Preventive Treatment) and young children (Seasonal Chemoprevention). It is considered relevant in contexts involving heightened systemic burden, such as when supportive symptomatic management is needed for conditions related to infections like Pneumocystis Jirovecii Pneumonia (PJP).

“The medication helps address symptoms that create noticeable physiological strain and supports the patient during difficult episodes by easing distress.”

Quick Fact: Relief for Acute Febrile Illness

This medication is applied in clinical settings that involve acute or unstable symptom patterns and is relevant for managing symptoms that interfere with daily comfort. This supportive use assists with maintaining functional stability and contributes to improved comfort during symptomatic periods.

Regulatory References

  1. WHO guidelines for malaria prevention in pregnancy

Eligibility and Restrictions for Use

The eligibility for using Fansidar (Sulfadoxine-Pyrimethamine) is strictly defined by regulatory documents based on a patient's age, specific health conditions, and physiological status.

Absolute Contraindications (Who Must Not Use)

Official labeling mandates that use is contraindicated in the following groups:

  • Patients with hypersensitivity to pyrimethamine, sulfonamides, or any component of the medication.
  • Patients with documented megaloblastic anemia due to folate deficiency.
  • Infants less than 2 months of age (due to the immaturity of their enzyme systems).
  • Prophylactic use in pregnancy at term and during the nursing period.
  • Repeated prophylactic use in patients with renal failure, hepatic failure, or blood dyscrasias.

Restricted and Conditional Eligibility

Use is permitted but requires caution in patients with pre-existing conditions that affect drug clearance or safety:

  • Individuals with impaired renal or hepatic function (monitoring is advised).
  • Those with possible folate deficiency or Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
  • Patients with severe allergy or bronchial asthma.

Age and Pregnancy Status

Age: The medication is approved for children 2 months of age and older. No specific, absolute contraindication unique to the geriatric population exists, but caution is advised.

Pregnancy: Use is generally not recommended during the first trimester. It may be used for specific preventive treatments (IPTp) starting in the second and third trimesters, but prophylactic use near delivery is prohibited.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Фансидар (Sulfadoxine-Pyrimethamine) has documented interaction patterns primarily centered on its activity as an antifolate agent and its potential for pharmacokinetic interference. Co-administration with other antifolate agents is subject to strict regulatory restriction. Combining the drug with Methotrexate is contraindicated due to the severe risk of folate deficiency-related toxicity, such as myelosuppression. The combination with Trimethoprim/Sulfamethoxazole is also formally designated as contraindicated due to similar additive antifolate-related adverse effects.

Pharmacodynamic risks extend to substances like Dapsone, where co-administration carries a documented risk of increased hematological toxicity. Pharmacokinetic interactions include the drug causing elevated plasma concentrations of Phenytoin and reported decreased plasma concentrations of Cyclosporin when co-administered.

Interaction constraints apply to consumption and elimination capacity. Co-ingestion of Alcohol may result in a disulfiram-like reaction. For administration timing, regulatory sources note that Folic Acid should be avoided on the same day or within two weeks due to pharmacodynamic antagonism. Furthermore, repeated prophylactic use is contraindicated in patients with renal failure or hepatic failure, a population-specific note reflecting the risk of accumulation.

Mechanism of Action

Ontology: How Фансидар works

Dual Competitive Inhibition and Sequential Blockade

Фансидар, a fixed-dose combination, exerts its effect through the synergistic antimetabolite action of its two components on the P. falciparum parasite. Sulfadoxine acts as a competitive inhibitor of the enzyme dihydropteroate synthase (DHPS), while pyrimethamine acts as a competitive inhibitor of dihydrofolate reductase (DHFR). This combined action achieves a sequential blockade of the parasite's essential folate synthesis pathway, which is necessary for the production of folinic acid.

Intracellular Consequence and Mechanistic Selectivity

The dual inhibition causes the irreversible depletion of purines and pyrimidines, leading to a critical failure in DNA and RNA replication and subsequently preventing parasite cell division (schizogony). The mechanism exhibits mechanistic selectivity by targeting the parasite’s de novo folate synthesis pathway, which is distinct from the human host’s mechanism of acquiring pre-formed folate. This targeting of unique parasitic metabolic processes mediates the inhibition of metabolic activity in the asexual blood-stage parasite.

Dosage and Administration Information

Sulfadoxine-Pyrimethamine, known by the trade name Фансидар, is administered exclusively via the oral route. The method for intake and the dosing schedule are established based on the intended clinical pattern.

Administration Guidelines

Instruction Administration Parameters
Dosing Schedule For acute treatment, the standard adult regimen is a single oral dose of 2 to 3 tablets (1000 mg/50 mg to 1500 mg/75 mg Sulfadoxine/Pyrimethamine). For prophylaxis, regimens include 1 tablet taken once weekly or 2 tablets taken biweekly.
Frequency Pattern Ranges from a single administration for acute episodes to weekly, biweekly, or monthly schedules for various preventive strategies.
Timing/Preparation Standard tablets must be swallowed whole with a full glass of fluids and are generally recommended to be taken after a meal. Dispersible forms must be dissolved in water before use.
Course Duration Prophylaxis typically extends for 4 to 6 weeks after leaving an endemic area, with continuous use generally limited to two years. For Intermittent Preventive Treatment in Pregnancy (IPTp), doses are administered monthly starting in the second trimester.

Population-Specific Rules

Standard use involves weight-based dosing for pediatric patients. For adult use, repeated prophylactic use is contraindicated for patients with chronic renal or hepatic failure. Administration of certain preventive doses may be conducted under Directly Observed Therapy (DOT) to ensure adherence to the prescribed frequency. The drug is generally contraindicated in infants less than two months of age.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Фансидар

Evidence for Preventing Malaria in Pregnancy (IPTp)

Research has explored the combination therapy's potential use for prevention in pregnant women. Research into this application includes Randomized Controlled Trials (RCTs), along with systematic reviews and meta-analyses that aggregate data across multiple trial sites. This research was primarily conducted in areas with moderate to high malaria transmission which were the subject of clinical evaluation.

Studies monitored various maternal and birth-specific outcomes. Researchers examined outcomes related to birth weight, specifically looking at the incidence of low birth weight and preterm birth. Additionally, studies monitored biological markers, such as the presence of parasite infection in the placenta and markers of maternal anemia. Findings describe patterns observed in the studies regarding these birth outcomes, and studies report measurements of markers of parasitic infection in the observed populations.

Evidence for Seasonal Malaria Prevention in Children (SMC)

Research exploring the use of this drug combination for Seasonal Malaria Chemoprevention (SMC) in children involves Cluster Randomized Controlled Trials and Pooled Analyses of Clinical Trials. These studies were applied in research contexts involving young children, typically aged 3 to 59 months, who lived in regions where malaria transmission is heavily seasonal. The evidence was evaluated in these settings to understand how the medicine's administration related to disease patterns.

Studies monitored specific clinical endpoints, including the incidence of uncomplicated and severe malaria episodes, rates of hospitalization, and all-cause mortality during the high-risk transmission period. Research describes group patterns related to the occurrence of these outcomes in children who participated in the study intervention compared to control groups.

What is Still Uncertain About the Research Evidence

The evidence landscape highlights what is known — and what is still uncertain. A major focus of ongoing research is associated with the constant development of drug resistance by the target parasites, which research suggests may influence the future use of this combination. Evidence quality varies across studies, especially for alternative uses like PJP prophylaxis, where comparative evidence is lacking against the gold standard regimen. Moreover, the evidence provides insight into short-term changes but does not definitively characterize long-term outcomes or effect patterns over many years.

Key Studies & References

  1. Prevention of malaria in pregnancy: The threat of sulfadoxine-pyrimethamine resistance (Systematic Review)
  2. Pneumocystis Pneumonia: Adult and Adolescent Opportunistic Infection Guidelines (NIH Clinical Info)

Frequently Asked Questions (FAQ)

Common questions about Фансидар (FAQ)

Q: What is Фансидар (Fansidar)?

Фансидар is a combination medicine containing two active ingredients: sulfadoxine and pyrimethamine. It is classified as an antimalarial drug. It works by interfering with the synthesis of folic acid in the Plasmodium parasite, which is necessary for its growth and reproduction.


Q: What is Фансидар (Fansidar) used to treat?

Фансидар is primarily used to treat and prevent certain types of malaria. It is often reserved for use in areas where other, less toxic antimalarial drugs are not effective due to drug resistance. It is specifically active against the Plasmodium falciparum parasite.


Q: How is Фансидар (Fansidar) taken?

Фансидар is typically taken by mouth as a tablet. The specific dosage and regimen (e.g., single dose or multiple doses over several days) depend on the reason for use (treatment vs. prevention), the patient's age and weight, and the geographical location where the malaria infection was acquired. It should be taken exactly as prescribed by a healthcare provider.


Q: What are the possible side effects of Фансидар (Fansidar)?

Common side effects may include nausea, vomiting, headache, loss of appetite, and dizziness. More serious, but less common, side effects can affect the skin (severe rashes like Stevens-Johnson syndrome), blood (e.g., aplastic anemia), and liver. Any severe or persistent side effects should be reported to a healthcare provider immediately.


Q: Who should not take Фансидар (Fansidar)?

Фансидар is generally contraindicated (should not be used) in patients with a known hypersensitivity or allergy to sulfa drugs or pyrimethamine. It is also typically avoided in patients with severe kidney or liver disease, certain blood disorders, or folate deficiency. Use during pregnancy and in infants requires careful medical review due to potential risks.


Q: Can I take Фансидар (Fansidar) if I am pregnant or breastfeeding?

The use of Фансидар during pregnancy, especially in the first trimester, is generally avoided unless the benefits outweigh the risks, as one of the active ingredients, pyrimethamine, is a folic acid antagonist. Consult a healthcare provider for personalized advice. The drug is excreted in breast milk, so caution is advised during breastfeeding.

How should Фансидар be stored and disposed of?

How to Store and Dispose of Fansidar (Sulfadoxine and Pyrimethamine)

Fansidar tablets must be stored at controlled room temperature, specifically 20 C to 25 C (68 F to 77 F). The medication must be kept in a tightly closed container and protected from heat, moisture, direct light, and must not be frozen.

As a mandatory safety requirement, the medicine must be stored out of the reach of children and away from pets.

Disposal Instructions

When the product is expired or no longer needed, it must be properly disposed of. The preferred method is using a recognized drug take-back program. If a program is unavailable, follow the procedure of mixing the tablets with an undesirable substance (such as used coffee grounds) and placing the mixture in a sealed container for household trash disposal. The container label must have all personal information scratched out.

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

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