Tragal

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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 Tragal

Quick Facts

Property Description
Active ingredient Sertraline hydrochloride
Form Tablets or oral solution (concentrate)
Pharmacological class Selective Serotonin Reuptake Inhibitor (SSRI)
Common use domain Mood disorders and anxiety conditions
Origin Synthetic small molecule

What is Tragal (Sertraline)?

Tragal is defined as a prescription-only psychotropic medication whose single active ingredient is the synthetic small molecule compound Sertraline hydrochloride. This medicine, which is clinically recognized for use across a wide adult patient group, is designed for oral administration and is available as tablets or an oral solution concentrate. Sertraline is commonly used for treating mood disorders. Its pharmaceutical profile allows for flexibility, as the oral solution provides an alternative to tablets for individuals who may require varied or more precise dosing adjustments. The preparation involves combining the active Sertraline with excipients necessary for stability and proper delivery into the body.

Pharmacological Class and General Purpose

Tragal belongs to the pharmacological class of Antidepressant agents and is specifically identified as a Selective Serotonin Reuptake Inhibitor (SSRI). This classification highlights its primary function: modulating brain chemistry. Sertraline is included within the Model List of Essential Medicines due to its established efficacy as an SSRI. As an SSRI, its general therapeutic purpose is to act as a first-line treatment by systematically restoring the balance of key chemical signals in the central nervous system. The substance's intended biological effect involves the inhibitory effect on presynaptic serotonin reuptake, a mechanism that sustains increased availability of the neurotransmitter serotonin (5-HT) to enhance serotonergic activity, thereby aiming to improve emotional processing and overall mood state.

Regulatory References

  1. National Institutes of Health (NIH)
  2. WHO Model List of Essential Medicines

What side effects are possible with Tragal?

Possible Side Effects and Safety Information

The official safety profile of Tragal (Sertraline) categorizes potential adverse reactions primarily by frequency and the body system affected, as documented in government regulatory sources. These classifications define the spectrum of officially listed possible effects, ranging from highly probable to rare, serious events.


Adverse Reaction Classification

Classification Examples of Officially Listed Effects
Very Common Nausea, Diarrhea, Dry mouth, Headache, Insomnia, Dizziness, Fatigue, Ejaculation failure (in males)
Common Tremor, Constipation, Vomiting, Dyspepsia, Decreased appetite, Sexual dysfunction (female)

Serious Adverse Reactions and Safety Constraints

Rare but serious reactions are documented in regulatory texts. These include the risk of Serotonin Syndrome, a potentially life-threatening condition. The label also notes the risk of suicidal ideation and behavior, particularly in children, adolescents, and young adults (age 18–24), and the potential for clinically significant abnormal bleeding events. Rare cardiac risks, such as QT interval prolongation and Torsade de Pointes (TdP), are also listed.

Use is explicitly restricted by contraindications, such as prohibiting co-administration with Monoamine Oxidase Inhibitors (MAOIs) due to the serious risk of Serotonin Syndrome, and co-administration with the drug Pimozide.

Exposure and Population-Specific Notes

The safety profile includes patterns related to treatment duration. The risk of suicidal thinking is generally associated with the start of treatment or following dose adjustments. Furthermore, safety statements address specific populations; for instance, patients with severe hepatic impairment require caution, and older adults have a documented increased risk of hyponatraemia (low sodium levels).

Overdose and Emergency Response

Overdose and When to Seek Help

The regulatory prescribing information for Tragal (Sertraline) specifies clinical manifestations and required emergency actions in the event of an overdose. These descriptions are based exclusively on official documented reports from regulatory authorities.


Documented Overdose Manifestations

Overdose may present with Central Nervous System (CNS) effects, including somnolence, agitation, tremor, confusion, and a loss of coordination. Cardiovascular signs are also noted, most commonly tachycardia (fast heart rate) and irregular heartbeat. Gastrointestinal disturbances, such as nausea and vomiting, are also documented symptoms.

Severe Outcomes and Emergency Action

Officially documented severe outcomes include life-threatening conditions such as Serotonin Syndrome, seizures, and coma. Cardiac complications, specifically QTc prolongation and Torsade de Pointes, are also stated risks. Death has been reported, primarily in cases where Tragal was ingested with other agents or alcohol.

Immediate medical attention is required upon any suspected overdose. Emergency medical care must be sought if the individual collapses, has a seizure, experiences trouble breathing, or cannot be awakened. Treatment is supportive and symptomatic, as no specific antidote is known for sertraline. ECG-monitoring is recommended due to potential cardiac risk.

Therapeutic Uses of Tragal

What Tragal Treats: Main Uses and Benefits

Tragal (Sertraline) is commonly used to help with symptomatic support across key domains of mental health. It is relevant in conditions characterized by periods of heightened symptoms that create noticeable interference with daily stability, assisting with easing the overall symptom load. The medication is also utilized for easing symptoms that create noticeable functional strain.

Easing Emotional Distress and Functional Strain

This medication is applied across domains where additional symptomatic support is needed, helping to address symptom clusters in conditions like 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). It is often used during phases when symptoms become more noticeable, offering supportive relief when symptoms interfere with routine activities.

This support helps address core emotional distress, such as persistent sadness and excessive worry, and assists with maintaining functional stability, contributing to a more manageable experience of chronic or recurrent low mood.


Quick Fact: Symptom Support
Primary Focus Symptom management for mood domains and pathological anxiety
Symptom Focus Easing intense worry and depressive feelings
Usage Scenario Applied in contexts involving acute or unstable symptom patterns
Core Benefit Supports general well-being during symptomatic periods

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Scope

Populations for whom use is allowed (as stated in label):

  • Adults (18 years and older) for all approved mental health conditions.
  • Pediatric patients aged 6 years and older for the treatment of Obsessive-Compulsive Disorder (OCD) only.

Populations for whom use is contraindicated:

  • Patients with known hypersensitivity to sertraline or any component of the formulation.
  • Patients receiving, or within 14 days of stopping, a Monoamine Oxidase Inhibitor (MAOI), including linezolid or intravenous methylene blue.
  • Concomitant use with Pimozide is prohibited.
  • The oral solution concentrate is contraindicated with Disulfiram due to the product's alcohol content.

Age-related eligibility rules:

  • Pediatric patients under 6 years of age: Safety and effectiveness have not been established.
  • Older Adults: Use is permitted, but caution is advised due to age-related physiological changes that may reduce clearance.

Condition-specific eligibility rules:

  • Severe Hepatic Impairment: Use is not recommended. Use in all degrees of liver impairment requires caution.
  • Renal Impairment: The official label states no dosage adjustment is necessary for patients with kidney impairment.

Eligibility-related restrictions:

  • Patients must be screened for Bipolar Disorder before initiating treatment.
  • Use should be avoided in patients with unstable epilepsy and in the third trimester of pregnancy due to documented risks to the neonate.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The official regulatory profile for Tragal (Sertraline) structures interaction constraints around specific pharmacological requirements and prohibitions documented by government authorities. Co-administration is contraindicated with Monoamine Oxidase Inhibitors (MAOIs), including Linezolid and Pimozide, due to the risk of Serotonin Syndrome or increased plasma exposure, respectively. A mandatory washout period of at least 14 days is required when switching from an irreversible MAOI to Tragal.

Tragal acts as an inhibitor of CYP2D6, a documented pharmacokinetic interaction that necessitates consideration for the dosage of co-administered medicines primarily metabolized by this enzyme. Co-administration with highly protein-bound drugs, such as anticoagulants, requires monitoring for potential plasma level changes. Pharmacodynamically, combining Tragal with other serotonergic agents or drugs that affect platelet function (e.g., NSAIDs) carries an officially documented increased risk of Serotonin Syndrome or bleeding/hemorrhage.

Consumption of alcohol is officially not recommended. The use of St. John's Wort is cautioned against due to enhanced serotonergic effects. For the oral solution concentrate, co-administration with Disulfiram is contraindicated. Furthermore, the official labeling notes that in patients with Hepatic Impairment, Tragal's clearance is reduced, leading to increased exposure, a population-specific pharmacokinetic consideration.

Mechanism of Action

Tragal operates via a dual mechanism focused on modulating platelet function. The drug initiates its primary action by selectively binding to the P2 Y12 receptor, a key surface protein found on platelets. This binding event alters the conformation of the receptor, preventing the endogenous ligand, adenosine diphosphate ( ADP), from coupling. Consequently, the intracellular signaling cascade typically triggered by ADP is interrupted. This specific modulation of the P2 Y12 pathway results in the inhibition of platelet aggregation. A secondary action involves the inhibition of the cyclooxygenase-1 ( COX-1) enzyme. This inhibition affects the eicosanoid pathway, further contributing to the overall pharmacological effect on platelet activity and downstream physiological processes.

Dosage and Administration Information

Tragal (Sertraline) is intended for oral administration only, available in dosage forms of tablets (25 mg, 50 mg, 100 mg) and as a 20 mg/mL oral solution concentrate.

Standard Regimens and Adjustment

The standardized adult starting dose is typically 50 mg once daily for certain conditions, or 25 mg once daily for conditions such as Panic Disorder. Dosing is structured as once daily, and the dose may be administered either in the morning or evening, and may be taken with or without food. Dose adjustments, if required, must proceed in 25 mg to 50 mg increments, with a minimum interval of one week between changes. The maximum approved daily dose for most indications is 200 mg. For Premenstrual Dysphoric Disorder (PMDD), the medicine may be administered continuously or through an intermittent schedule during the luteal phase of the menstrual cycle.

Special Preparation and Populations

The oral solution concentrate requires specific preparation prior to use. The exact dose must be measured using the supplied calibrated dropper and immediately diluted with at least 4 ounces (1/2 cup) of only the specified diluents: water, ginger ale, lemon/lime soda, lemonade, or orange juice. The mixture must be consumed right away. For individuals with mild hepatic impairment, the official protocol requires the starting and maximum dose to be reduced by half. For pediatric patients aged 6–17 with OCD, a distinct, lower starting dose is used before titration toward the maximum 200 mg daily dose.

Recent Clinical Evidence

Tragal: Recent Clinical Evidence

The information below summarizes the clinical research context for Tragal (Sertraline) derived from authoritative regulatory and scientific sources, focusing on what the studies explored. This overview provides context but not individual predictions or medical advice.

Evidence for Major Depressive Disorder (MDD) and OCD

Research for MDD and Obsessive-Compulsive Disorder (OCD) includes short-term, randomized controlled trials (RCTs) examining how symptoms change over defined intervals (e.g., 8–12 weeks). Studies reported measurements of symptom severity change and explored recurrence prevention for MDD in longer-term prophylactic studies. For OCD, long-term studies track the stability of symptom patterns to examine long-term outcomes. Data for patients with complex medical comorbidities remain insufficient to draw broad conclusions.

Evidence for Anxiety and Stress-Related Disorders

Tragal was evaluated in short-term RCTs for Panic Disorder (PD), where studies monitored the frequency of panic attacks and anticipatory anxiety. For Social Anxiety Disorder (SAD), research explored symptom changes over intermediate-term durations (12–24 weeks). For Post-traumatic Stress Disorder (PTSD), short-term RCTs monitored overall symptom severity, though evidence quality may vary across reviews, and inconsistency in the magnitude of the measured outcomes was noted in some analyses.

Evidence in Specific Populations and Gaps

Tragal was evaluated in specific populations, including children and adolescents with MDD and OCD, and older adults. Analyses suggested that outcomes differences may be smaller in the older adult group. The results apply only to the populations studied, and the evidence for long-term effects are not fully established for all indications. Data related to functional outcomes beyond symptom stability are still emerging.

Key Studies & References Is Sertraline a Good Pharmacological Strategy to Control Anger? Results of a Systematic Review

Frequently Asked Questions (FAQ)

Common questions about Tragal (FAQ)


Q: How quickly should I expect Tragal to start working?

Studies and official information indicate that it generally takes 4 to 6 weeks to experience the full therapeutic effect of Tragal. However, early changes in areas like sleep patterns or energy levels may start to occur within the first 1 to 2 weeks of use. The importance of continuing the prescribed regimen, even when immediate results are not apparent, is often emphasized in patient information.


Q: Are there any foods or drinks I need to avoid while taking Tragal?

Official information cautions against consuming grapefruit or grapefruit juice, as these products can affect the level of the medicine in the body. Consumption of alcohol is generally described as not recommended in official patient information due to the potential for enhanced side effects.


Q: Can Tragal change my mood or cause anxiety?

Official safety warnings note that the medicine may cause new or worsened symptoms such as anxiety, agitation, panic attacks, or unusual changes in behavior. This is most often noted when treatment is started or following a dose adjustment. This is a documented possibility of which patients are generally informed.


Q: Does Tragal need to be taken with food?

Tragal tablets can be taken either with or without food, as noted in the official prescribing information. The product information indicates that taking the medicine with food is an option that some patients use to lessen the chance of experiencing stomach upset or nausea.


Q: Is Tragal a type of painkiller?

Official drug classification defines Tragal as a Selective Serotonin Reuptake Inhibitor (SSRI), which is a type of antidepressant agent. It is primarily intended to modulate brain chemistry for mood and anxiety conditions, and it is not classified as a painkiller (analgesic) for treating physical pain.


Q: Does Tragal interact with common over-the-counter pain relievers?

Official interaction warnings note that taking Tragal with non-steroidal anti-inflammatory drugs (NSAIDs) or Aspirin may increase the documented risk of bleeding or hemorrhage. This interaction relates to how both classes of medicine can affect the function of platelets.


Q: Is it common to feel tired when first starting Tragal?

Drowsiness, dizziness, and fatigue are listed among the very commonly reported effects in official product information. This may be more noticeable when a person first begins taking the medicine, but these effects can occur at any point during use.


Q: Will Tragal affect my ability to drive or operate machinery?

Because this medicine may cause drowsiness or dizziness, official patient information advises caution. Official patient information generally cautions patients to exercise care when driving a car or operating machinery until they are reasonably certain how Tragal affects them.


Q: What are the long-term effects of taking Tragal?

Long-term use is associated with certain documented effects, including potential changes in weight and the presence of sexual dysfunction. Official guidance documents also emphasize the documented requirement for gradually reducing the dose when treatment is being discontinued.


Q: Why do some people say Tragal didn't work for them?

Official documents acknowledge a large variability in how individual patients metabolize and respond to the medicine. This natural biological difference can lead to variations in the steady-state concentrations of the drug and, consequently, variations in how effectively Tragal works for different people.


Q: Does Tragal have potential for misuse or dependence?

Tragal is not designated as a controlled substance and is not associated with abuse or addiction. However, discontinuing the medicine suddenly may result in documented discontinuation-related symptoms. A gradual reduction in dose is commonly documented as necessary to minimize the potential for these symptoms.


Q: What does the term 'contraindication' mean for Tragal?

A contraindication is a recognized symptom, medical condition, or co-treatment that makes using a medicine potentially harmful or unsafe for a person. Official documents use this term to list specific situations where Tragal must not be taken.


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

Routine therapeutic drug monitoring is not typically required for this medicine. However, blood tests may be performed to check for documented rare effects, such as low sodium levels, or to monitor for interactions with certain other medications like anticoagulants.


Q: Is Tragal effective for all stages of the condition it treats?

Clinical studies generally focus on demonstrating the medicine's effectiveness against a placebo across the patient population that was studied. Specific efficacy data regarding its effectiveness across every single stage of a condition is not always explicitly generalized in the official materials.


Q: Does Tragal cause weight gain or weight loss?

Official product information notes that both weight gain and weight loss have been reported in clinical studies as possible side effects. Decreased weight has been specifically documented in research involving pediatric patients with OCD.


Q: Can Tragal be crushed or split?

Tragal tablets may be scored, which often indicates they can be divided. However, other forms, such as the oral solution concentrate, have specific preparation instructions. The specific instructions for crushing or splitting any tablet form should always be verified by the user with a healthcare professional.


Q: Does Tragal interact with diabetes medications?

Official information indicates that Tragal may increase the risk of low blood sugar (hypoglycemia) when taken with insulin or certain other anti-diabetes medicines. This is a documented interaction, and protocols may involve blood sugar monitoring.


Q: Is Tragal a short-term or long-term medicine?

Tragal is sometimes prescribed for long-term use as part of a maintenance regimen for chronic conditions. Official guidance notes that suddenly stopping the medicine, even after symptoms have improved, carries a risk of discontinuation symptoms.


Q: What is the average time before seeing results with Tragal?

Studies and official documentation indicate it generally takes 4 to 6 weeks to experience the full therapeutic effect. Early changes in areas like sleep or energy levels may start to occur within the first 1 to 2 weeks of use.


Q: What are the known interactions between Tragal and cold or flu medicine?

Official warnings highlight that certain cold or flu medicines may interact with Tragal. This includes products containing ingredients like dextromethorphan or sympathomimetics, which may increase the risk of serious side effects.

How should Tragal be stored and disposed of?

How to Store and Dispose of Tragal

Official regulations require specific storage and disposal for Tragal (sertraline) to maintain product stability and safety.


Storage Requirements

Tragal tablets and oral solution must be stored at controlled room temperature, between 20 C and 25 C (68 F and 77 F). The medicine must be kept from freezing and protected from excessive moisture and light. Keep the medicine in its tightly closed container and out of the reach of children.


Stability and Disposal

Tragal oral solution concentrate must be discarded 30 days after first opening. Unused or expired Tragal should be disposed of using a drug take-back program. The product should not be flushed or released into the environment due to its toxicity to aquatic life.

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

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