Eleval

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Eleval

What is Eleval? (Sertraline)

This foundational section establishes the core identity of Eleval, defining its composition, classification, and general therapeutic purpose, strictly avoiding details on specific conditions, dosages, instructions, or safety warnings.

Property Description
Active ingredient Sertraline (Sertraline hydrochloride)
Form Oral dosage form (e.g., film-coated tablets)
Pharmacological class Selective Serotonin Reuptake Inhibitor (SSRI)
Common purpose Supports the regulation of mood and emotional balance
Origin Synthetic compound

What Type of Medicine is Eleval, and How is it Classified?

Eleval is a prescription-only medicine containing the single INN (International Nonproprietary Name) active ingredient, Sertraline. It is classified as a Selective Serotonin Reuptake Inhibitor (SSRI), placing it within the broader group of antidepressants and psychotropic agents used to modulate key chemical messengers in the brain. Sertraline hydrochloride is a synthetic derivative of naphthalenamine with anti-serotoninergic properties. The efficacy of the SSRI class in managing emotional imbalances is recognized across pharmacological studies. This focused action on serotonin distinguishes it from older, less specific antidepressant classes.


Composition, Dosage Form, and General Purpose

The medication is supplied as an oral dosage form, typically a film-coated tablet, which allows for consistent, systemic administration. As a single active ingredient product, Eleval exclusively contains the synthesized compound Sertraline, alongside necessary excipients that form the solid matrix of the tablet. Sertraline, as an SSRI, is recognized for its mechanism of balancing mood-affecting chemical messengers. The confirmed action is to help the brain maintain better mental balance by improving serotonin signaling. This underlying mechanism connects directly to the medication’s general purpose: to support the stabilization and regulation of mood and emotional balance.

What side effects are possible with Eleval?

Possible Side Effects and Safety Information

The safety profile of Eleval (Sertraline) is formally documented in government regulatory materials and structured according to frequency and the body's affected system. These classifications are based on aggregated clinical trial data and subsequent surveillance.

Frequency-Classified Adverse Reactions

The incidence of adverse reactions is categorized using standard regulatory frequency bands:

Classification Examples of Reactions
Very Common (1/10) Nausea, Diarrhea, Dry mouth, Insomnia, Somnolence, Headache, Dizziness, Fatigue, Ejaculation failure (in males).
Common (1/100 to <1/10) Decreased libido, Anorexia, Tremor, Dyspepsia, Anxiety, Agitation, Increased sweating (Hyperhidrosis).

These effects are grouped into System-Organ Classes (SOCs), including Gastrointestinal disorders, Nervous system disorders, and Psychiatric disorders.

Serious Adverse Reactions and Constraints

Official labeling includes warnings for potentially serious but less frequent events. Documented Serious Adverse Reactions include Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like events, and an Increased risk of bleeding. Caution is also noted regarding the potential for QTc prolongation and Angle-closure glaucoma.

Specific Safety Constraints exist, such as the absolute Contraindication for concomitant use with Monoamine Oxidase Inhibitors (MAOIs). Furthermore, safety information notes that the risk of suicidal thoughts and behaviors is increased in children, adolescents, and young adults during the initial phases of treatment or dose adjustment.

Population-specific safety considerations are documented for certain groups. For example, use in patients with hepatic (liver) impairment requires caution due to potential drug exposure changes, and pediatric patients face a higher risk of clinically significant weight loss.

Overdose and Emergency Response

Overdosage with Eleval (Sertraline) may present with a specific profile of documented clinical manifestations. These commonly include central nervous system (CNS) effects such as somnolence, agitation, confusion, and tremor, alongside gastrointestinal disturbances like nausea and diarrhea. Cardiovascular changes may involve tachycardia (rapid heart rate) and, in severe cases, the risk of QTc prolongation.

Regulatory information highlights the risk of severe and life-threatening outcomes that necessitate emergency intervention. These include the development of Serotonin Syndrome, which may be indicated by fever and severe muscle stiffness, as well as seizures and coma (loss of consciousness).

Official guidance mandates that immediate medical attention be sought for any suspected overdose. Emergency services must be contacted immediately if an individual has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened. Management procedures are strictly supportive and symptomatic. While activated charcoal may be used, no specific antidotes are known for sertraline. The risk of fatal outcomes is noted to increase significantly when Eleval is ingested in combination with alcohol or other concomitant medication.

Therapeutic Uses of Eleval

What Eleval Treats: Main Uses and Benefits

Eleval is applied across domains where additional symptomatic support is needed, primarily for conditions involving mood, anxiety, and compulsive thought patterns. It helps address symptom clusters that may become intense or disruptive and is relevant in contexts marked by increased discomfort or tension across several key clinical presentations.

Eleval is commonly used across conditions presenting with symptom patterns of Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder (PD), Social Anxiety Disorder (SAD), Post-Traumatic Stress Disorder (PTSD), and Premenstrual Dysphoric Disorder (PMDD). This medication targets symptoms that interfere with daily functioning, such as profound sadness, recurrent panic, and intrusive obsessions.

Used in situations involving certain distressing symptoms, Eleval contributes to easing the overall symptom load and helps maintain a sense of stability when symptoms are more noticeable. It offers symptomatic relief that helps patients cope more steadily with symptom fluctuations.

“The primary goal is supportive relief, assisting with managing symptoms that create noticeable functional strain and supports general well-being during symptomatic phases.”


Quick Fact: Relief for Obsessions and Compulsions Eleval is commonly used to help with the intensity and frequency of recurrent, unwanted obsessions and ritualized compulsions, assisting with maintaining functional stability in both adult and pediatric populations.


This application is relevant in clinical settings that involve recurrent or episodic manifestations, and supportive relief is often used during phases when symptoms become more noticeable.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Eleval — Official Regulatory Information

Eligibility scope Statement based strictly on Regulatory Labeling
Populations for whom use is allowed Adults (18 years and older). Pediatric patients (6 to 17 years old) only for the treatment of Obsessive-Compulsive Disorder (OCD).
Populations for whom use is contraindicated Patients with known hypersensitivity to Sertraline. Patients taking or within 14 days of stopping a Monoamine Oxidase Inhibitor (MAOI), including Linezolid and intravenous Methylene Blue. Patients concurrently taking Pimozide.

Eligibility Classifications (High-Level)

Classification Category Official Regulatory Statement
Eligibility severity classification Contraindicated (MAOIs, Pimozide, Hypersensitivity); Not Recommended (Severe Hepatic Impairment); Use with Caution (Seizure disorders, Older Adults).

Resulting Eligibility Structure

Official eligibility statements:

  • The medicine is approved for adults but is not established for use in children under 6 years of age or for pediatric patients with indications other than OCD.
  • Use requires special caution in populations with hepatic impairment (liver disease), a history of mania, seizure disorders, or those who are older adults due to increased risk of hyponatremia.
  • Pregnancy: Use during the third trimester may increase the risk of specific adverse effects in the newborn.

Connection to the overall eligibility profile: Regulatory documents define eligibility by establishing absolute prohibitions (contraindications) and by setting conditional use parameters that require caution for patients with pre-existing conditions, such as liver impairment, or those who are at specific age or physiological risks.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction Scope

Medicinal product categories with documented interactions include Monoamine Oxidase Inhibitors (MAOIs), other Serotonergic Agents, Antiplatelet Drugs, Anticoagulants, and CYP2D6 Substrates. Specific medicines explicitly listed in official documentation as interacting include Pimozide, Warfarin, and certain NSAIDs. The mechanistic basis of the interactions is described as both Pharmacodynamic, involving the additive risk of Serotonin Syndrome and increased bleeding, and Pharmacokinetic, where Eleval functions as an inhibitor of the CYP2D6 isoenzyme, which may result in increased plasma concentrations of co-administered CYP2D6 substrates.

Interaction Classifications (High-Level)

Interaction severity classification, as defined in official documents, includes Contraindicated Combinations (e.g., MAOIs, Pimozide). A mandatory 14-day wash-out period must separate the discontinuation of an MAOI and the initiation of Eleval, in either direction. For patients with mild hepatic impairment, official data documents a significant reduction in clearance, leading to approximately a three-fold greater total exposure to the drug. The Eleval tablet form taken with food results in a documented 25% increase in peak plasma concentration (Cmax).

Official interaction statements:

  • Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is contraindicated, requiring a 14-day separation period between use.
  • Pimozide is contraindicated due to the officially documented risk of elevated plasma concentration and QTc prolongation.
  • The risk of bleeding is increased when Eleval is co-administered with antiplatelet agents or anticoagulants.
  • Consumption of Alcohol is stated to be avoided, and co-administration with St. John's Wort may increase the risk of Serotonin Syndrome.

Connection to the overall interaction profile (2–4 sentences):

The regulatory profile establishes constraints based on strict contraindications (MAOIs, Pimozide) and requirements for managing pharmacokinetic interactions due to enzyme inhibition (CYP2D6). This structure defines the documented limits for co-administration, including timing rules and specific exposure changes in the presence of food and liver impairment.

Mechanism of Action

Eleval's primary mechanism involves the Serotonin Transporter ( SERT), a protein on nerve cell membranes. The molecule acts as a selective inhibitor of this transporter, a specific action used to alter the concentration of the neurotransmitter serotonin (5- HT) in the synaptic cleft. By blocking SERT, Eleval prevents the reabsorption of serotonin into the transmitting nerve cell, which initiates a cascade of effects resulting in altered pathway activity.

The initial molecular action leads to a crucial secondary mechanistic domain: adaptive cellular remodeling. The sustained elevation of serotonin triggers structural changes, including the eventual down-regulation of receptors and the upregulation of growth factors, such as Brain-Derived Neurotrophic Factor ( BDNF). This engagement of mechanisms that modulate signaling sequences is applicable where specific pathway modulation is required. These modifications lead to measurable physiological effects by modifying the functional and structural capacity of the central nervous system circuitry.

Eleval's pharmacological profile also involves a secondary mechanism as a ligand for the Sigma-1 (sigma1) receptor and weak interaction with the dopamine transporter. This multiple mechanistic interactions are used to modulate signaling patterns within its known pathways. The combined actions influences the activity of the Hypothalamic-Pituitary-Adrenal (HPA) axis, resulting in altered physiological activity.

Dosage and Administration Information

Eleval is administered orally and exclusively on a once-daily basis. The tablets or capsules may be taken with or without food. Administration is typically structured in three phases: initiation, titration, and maintenance.

Regimen Component Instruction
Initial Dose 25 mg to 50 mg once daily, dependent on the condition.
Dose Titration Increases of 25 mg to 50 mg are permitted at intervals of no less than one week.
Maximum Dose 200 mg once daily for most adult indications.

For the oral concentrate, the solution must be diluted immediately before use with specific approved liquids, including water, ginger ale, or orange juice. Special procedural conditions apply to certain populations: use in children is restricted to Obsessive-Compulsive Disorder (OCD, ages 6-12 start at 25 mg), and patients with mild hepatic impairment require a dose reduction to half the recommended starting and maximum dose. If a scheduled daily dose is missed, it is taken as soon as it is remembered unless it is almost time for the next dose, in which case the missed dose is skipped; doses must never be doubled. Treatment conclusion requires a gradual dose reduction (tapering).

Recent Clinical Evidence

Eleval: Recent Clinical Evidence

This section provides a factual overview of the clinical research and study landscape for Eleval (Sertraline), detailing the types of evidence and the outcomes that researchers examined. This summary describes the available research, not to offer clinical advice or interpretations of individual outcomes.


Study Design and Evidence Landscape

The foundational evidence for Eleval primarily consists of short-term randomized controlled trials (RCTs) and longer maintenance and relapse prevention studies. This research was applied in studies examining patient-reported experiences, and the core focus was to measure symptom patterns across various conditions where symptom intensity may vary. The initial clinical evaluation was conducted in controlled research settings, providing a standardized basis for evaluating the measurements observed, often comparing outcomes to an inactive substance (placebo).

Research Across Key Conditions

Research explored the medicine in adults and adolescents with Major Depressive Disorder (MDD), often using acute-phase RCTs to track changes in validated depression rating scales. Evidence for Panic Disorder (PD) and Social Anxiety Disorder (SAD) is derived from short-term RCTs that monitored changes in the frequency of panic attacks and social fear and avoidance behaviors. For Post-Traumatic Stress Disorder (PTSD), trials examined outcomes related to the reduction of core symptom clusters. The research landscape for Obsessive-Compulsive Disorder (OCD) is defined by controlled trials in adults and pediatric patients that measured changes using the Y-BOCS scale.

Long-Term Follow-up and Research Gaps

While studies explore the durability of the measured symptomatic changes for up to a year, dedicated, long-term, placebo-controlled data on the maintenance of measured symptomatic change beyond one year are not fully established for all indications. Furthermore, data for certain groups remain limited, such as those with complex co-morbid diagnoses or specific concurrent medical conditions. Comparative evidence is lacking for dedicated research comparing Eleval to newer or non-pharmacological treatments in head-to-head trials for certain conditions.

Key Studies & References

  1. NICE Guideline: Depression in adults: recognition and management

Frequently Asked Questions (FAQ)

Common questions about Eleval (FAQ)


Q: How quickly does Eleval start working?

According to official regulatory data, the medicine reaches a steady-state concentration in the bloodstream after about one week of taking it once daily. However, the time it takes for measurable symptom improvement to be observed in clinical trials can be highly variable and differs among individuals and the condition being addressed.

Q: Can Eleval be taken with daily vitamins or herbal supplements?

Official information explicitly advises that combining Eleval with the herbal supplement St. John's Wort is not recommended due to an increased potential risk for Serotonin Syndrome. Regulatory materials do not document specific warnings or interactions regarding common routine daily vitamins.

Q: What is the general withdrawal experience after stopping Eleval?

If the medicine is stopped abruptly, official sources report that patients commonly experience withdrawal symptoms. These effects often include dizziness, sleep disturbances, feelings of anxiety or agitation, nausea, and tremor. The symptoms are generally described as mild to moderate and are often temporary.

Q: Is Eleval safe to use during pregnancy?

Official product information states that taking the medicine during the third trimester of pregnancy may be associated with an increased risk of specific adverse effects in the newborn. Regulatory guidance indicates that the potential benefits must be weighed against the risks to the unborn child when considering use during pregnancy.

Q: Can Eleval be taken while breastfeeding?

The active ingredient and its metabolite are documented in official sources as being present in human milk. Official guidance requires an evaluation of the potential exposure for the breastfed infant against the patient's clinical need for the medication.

Q: Can Eleval affect my ability to drive or operate machinery?

Official safety information notes that side effects like drowsiness (somnolence) or dizziness may affect one's ability to drive or use heavy machinery. Official safety information recommends caution and suggests that individuals determine how the medicine affects them before engaging in tasks requiring full mental alertness.

Q: What is the risk of dependence or addiction with Eleval?

Official studies indicate that the medicine has not demonstrated a potential for abuse or addiction. However, it is essential that the treatment is concluded with a gradual dose reduction (tapering), as stopping suddenly commonly leads to withdrawal symptoms.

Q: Is Eleval used for anything else besides its main purpose?

The medicine is only approved for use in specific conditions documented in official regulatory materials, such as Major Depressive Disorder and various anxiety and compulsive disorders. The use of the medicine for other conditions is not addressed in official labeling.

Q: Does Eleval cause weight gain or weight loss?

Official adverse reaction lists commonly note anorexia (decreased appetite) and overall weight loss in adults, and the risk of significant weight loss is higher in pediatric patients. The regulatory documents also indicate that weight gain is a possible, though less common, event.

Q: Are there any long-term effects of taking Eleval?

The primary evidence base consists of short-term clinical trials and maintenance studies that tracked the durability of measured changes for up to one year. Official sources indicate that dedicated, long-term, placebo-controlled data on effects lasting beyond one year are not fully established for all approved conditions.

Q: Does Eleval affect fertility?

Studies in animals have suggested that the medicine may affect sperm quality in mice. However, official regulatory information notes that a consistent effect on human fertility has not been clearly established in controlled clinical studies.

Q: Can Eleval affect blood sugar levels?

Official reports have noted that the use of the medicine has been occasionally associated with changes in blood sugar control, including both decreases (hypoglycemia) and increases (hyperglycemia) in sugar levels. This is especially noted in patients who have pre-existing diabetes.

Q: Do I need to get blood tests while taking Eleval?

Official labeling notes that the medicine may infrequently cause a decrease in white blood cells or low sodium levels (hyponatremia). These findings suggest specific monitoring may be required in some situations, but there is no blanket requirement for all patients to undergo routine blood tests.

Q: Does Eleval have any known interactions with grapefruit juice?

Yes, official reports advise that taking the medicine with grapefruit or grapefruit juice is not recommended. This is because official information indicates that the juice may increase the concentration of the medicine in the bloodstream, potentially leading to a higher risk of side effects.

Q: Are there any precautions for sun exposure while on Eleval?

Official regulatory materials contain a warning that use of the medicine has been associated with an increased risk of photosensitivity reactions (increased sensitivity to sunlight). Because of this, standard sun precautions are advised for patients while taking this medication.

How should Eleval be stored and disposed of?

The storage and disposal of Eleval (Sertraline) are governed by official regulations to ensure product stability and public safety.

Official Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature (e.g., 15 C to 30 C).
Handling Keep from freezing and store away from excess heat and high moisture areas.
Protection Keep the medicine in its original container, tightly closed, and shielded from direct light.
Safety Rule Keep out of the sight and reach of children at all times.

Official Disposal Rules

Expired or unused Eleval should not be retained. The preferred disposal method is using an authorized drug take-back program. If a take-back option is unavailable, the medicine must not be flushed. Instead, remove the tablets from the container, mix them with an undesirable substance like dirt or used coffee grounds, place the mixture in a sealed bag or container, and discard it in the household trash.

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

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