Dagrilan

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Dagrilan

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 Dagrilan

Dagrilan (Fluoxetine): Quick Facts

Property Description
Active ingredient Fluoxetine Hydrochloride
Form Capsules (including delayed-release), Tablets, Oral Solution
Pharmacological class Selective Serotonin Reuptake Inhibitor (SSRI)
Common use Modulation of mood and emotional balance
Origin Synthetic organic compound

What Type of Medicine is Dagrilan (Fluoxetine)?

Dagrilan is a prescription-only psychotropic agent whose active substance is the synthetic compound Fluoxetine. It is classified within the group of modern Antidepressants, specifically as a Selective Serotonin Reuptake Inhibitor (SSRI). This classification is significant as it indicates a focus on regulating the body’s serotonin system. Fluoxetine is a medication clinically utilized for addressing various mood and emotional health concerns.

This pharmacological classification defines its specific action on neurochemistry. Fluoxetine is a racemic mixture of two mirror-image molecules, a feature distinguishing its precise metabolic profile. The general purpose of this type of medication is to help stabilize mood, restore emotional balance, and improve overall affective state.

Composition, Forms, and General Function

The therapeutic foundation of Dagrilan is the single active ingredient, Fluoxetine Hydrochloride. As a synthetic organic compound, it is consistently manufactured for precise therapeutic application.

Dagrilan is administered via the oral route and is available in multiple dosage forms, including standard capsules and tablets, as well as an oral solution and specialized delayed-release capsules. As an SSRI, it functions by inhibiting the neuronal reuptake of serotonin. This action ensures that the necessary chemical messengers remain available for longer, thereby enhancing serotonergic neurotransmission to promote improved signaling in the brain.

What side effects are possible with Dagrilan?

Dagrilan's official safety profile, as defined by government regulatory documents, is structured around the frequency and physiological grouping of documented adverse reactions. These effects are systematically classified from Very Common to Rare.

Adverse Reaction Scope

Classification Key Documented Effects (Examples)
Very Common (1/10) Insomnia, Headache, Nausea, Diarrhea, and Fatigue (Asthenia).
Common (1/100 to <1/10) Anxiety, Nervousness, Decreased libido, Tremor, Dry mouth, Rash, and Somnolence.

Adverse reactions are grouped by System-Organ Classes (SOC), including effects on the Gastrointestinal System, Nervous System, and Psychiatric Status. The regulatory labeling highlights several Serious Adverse Reactions, including the potential for Serotonin Syndrome and serious allergic reactions that may require immediate cessation of use.

A required Boxed Warning notes an increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults, particularly during the initial phase of treatment or following dose adjustment. Caution is specifically advised for older adults due to the increased risk of Hyponatremia (low sodium). Furthermore, official safety constraints include a contraindication with non-selective, irreversible Monoamine Oxidase Inhibitors (MAOIs), and specific warnings regarding cardiac risks like QT prolongation and the potential for Abnormal Bleeding.

This structure ensures that all documented risks, from expected initial side effects to rare but serious concerns and population-specific warnings, are systematically communicated.

Overdose and Emergency Response

Overdose and When to Seek Help

Documented Overdose Profile

Official regulatory documents define an overdose of Dagrilan as the ingestion of a dose greater than the maximum recommended therapeutic dose. The severity of an overdose can range from asymptomatic to life-threatening, depending on the amount ingested and individual patient factors. While specific manifestations vary, serious complications documented in regulatory sources may include specific organ dysfunction (if known) or severe cardiovascular and central nervous system effects.

Urgent Medical Action

Immediate medical attention must be sought in all cases of suspected or confirmed Dagrilan overdose. This instruction is required by government regulatory bodies (such as the FDA and EMA) to ensure patient safety. Patients or caregivers should immediately contact emergency services or a certified Poison Control Center for guidance.

Management of Overdose

The management of Dagrilan overdose, as outlined in official labeling, is primarily supportive and symptomatic. Healthcare professionals will generally initiate general supportive measures, maintain a patent airway, and monitor vital signs, including cardiac and respiratory function, until the patient is stable. Depending on the time since ingestion and the amount taken, procedures such as gastrointestinal decontamination (e.g., activated charcoal or gastric lavage) may be implemented to reduce systemic absorption. If a specific antidote for Dagrilan is known and documented in regulatory prescribing information, it will be administered under medical supervision.

Therapeutic Uses of Dagrilan

Dagrilan is commonly used to help manage the burden of significant emotional, mood, and behavioral symptoms, assisting with maintaining functional stability. This medication is relevant in clinical settings for managing the symptomatic burden across several psychiatric conditions.

Dagrilan generally helps address symptom clusters that may become intense or disruptive, such as the persistent low mood and loss of interest associated with Major Depressive Disorder (MDD), the intrusive thoughts and ritualistic actions of Obsessive-Compulsive Disorder (OCD), and the unexpected episodes of intense fear characteristic of Panic Disorder. It is also applied in specific behavioral health contexts, including the disruptive patterns of Bulimia Nervosa and the severe mood swings seen in Premenstrual Dysphoric Disorder (PMDD).

It is applied in situations where additional symptomatic support is needed, whether for acute episodes or for long-term supportive management, which supports patients during difficult episodes by easing distress.


Quick Fact: Relief for Symptomatic Discomfort
Dagrilan is considered relevant in contexts marked by increased discomfort or tension, supporting the management of symptoms that interfere with daily functioning and emotional distress.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility and Contraindications

Dagrilan (Fluoxetine) is authorized for use in adult patients for all approved indications. It is also formally established for pediatric use in children aged 8 and older for Major Depressive Disorder (MDD) and children aged 7 and older for Obsessive-Compulsive Disorder (OCD). Safety and effectiveness are not established below these minimum age thresholds.


Absolute Prohibitions

The medicine is contraindicated and must not be used by patients with a known hypersensitivity to the drug. Absolute non-eligibility also applies to patients concurrently taking specific medications, including Monoamine Oxidase Inhibitors (MAOIs), Pimozide, or Thioridazine, due to the risk of serious interactions that require mandatory washout periods.


Conditional and Restricted Use

Caution and possible dosage adjustments are necessary for patients with hepatic impairment (liver disease) and for older adults. Use during pregnancy is conditional and only advised if the potential benefit justifies the potential risks to the fetus. Breastfeeding is officially not recommended. Additional caution is required for individuals with a history of seizures or risk factors for QT prolongation.

What should I know about interactions with other medicines?

Dagrilan (Fluoxetine) is known to interact with several medicinal products and categories, primarily through two mechanisms: increasing serotonergic activity and inhibiting the CYP2D6 enzyme pathway.

Contraindicated Combinations

The use of Dagrilan is strictly contraindicated with Monoamine Oxidase Inhibitors (MAOIs), including Linezolid and intravenous Methylene Blue, due to the high risk of developing a serious condition called Serotonin Syndrome. A washout period is mandatory: at least 14 days must pass after discontinuing an MAOI before starting Dagrilan, and at least five weeks must pass after stopping Dagrilan before starting an MAOI. Dagrilan is also contraindicated with Pimozide and Thioridazine due to the risk of QTc prolongation.

Clinically Significant Interactions

Interacting Product/Category Interaction Mechanism Clinical Risk
Other Serotonergic Drugs (e.g., triptans, SSRIs, SNRIs, Tramadol, Tryptophan) Additive serotonergic effects Increased risk of Serotonin Syndrome.
Drugs Metabolized by CYP2D6 (e.g., tricyclic antidepressants, certain antipsychotics, Metoprolol, Flecainide) Dagrilan is a potent CYP2D6 inhibitor Elevated plasma concentrations of co-administered drug; increased risk of toxicity.
Antiplatelet Agents/Anticoagulants (e.g., NSAIDs, Aspirin, Warfarin) Interference with hemostasis Increased risk of abnormal bleeding.

Close monitoring or dose adjustment is required for co-administration with these categories, particularly for drugs with a narrow therapeutic index or those metabolized by CYP2D6.

Mechanism of Action

How Dagrilan Works: Mechanism of Action

Dagrilan exerts its primary pharmacodynamic effect through Dual Neurotransmitter Reuptake Inhibition. It functions as an inhibitor of two crucial membrane proteins in the central nervous system: the Serotonin Transporter (SERT) and the Norepinephrine Transporter (NET). By binding to and blocking these transporters, Dagrilan prevents the reuptake of the neurotransmitters Serotonin and Norepinephrine from the synaptic clefts into the presynaptic neuron. This action rapidly increases the concentration and residence time of both monoamines in the synapse, causing an immediate alteration of monoaminergic signaling.

This sustained neurochemical alteration initiates Long-Term Neuroplasticity and Trophic Factor Modulation. Chronic receptor stimulation activates intracellular signaling cascades (e.g., CREB), enhancing the transcription and production of Neurotrophic Factors such as BDNF. This cascade induces the structural remodeling of neural circuits, resulting in the long-term physiological effect of altered neural connectivity and synaptic density.

Dagrilan's dual action also contributes to the Modulation of Descending Pain Pathways. By augmenting the availability of Serotonin and Norepinephrine in the descending inhibitory pathways projecting from the brainstem to the spinal cord, the mechanism augments the activity of the body's natural inhibitory response, resulting in the physiological effect of modulation of nociceptive signaling via central pathways.

Dosage and Administration Information

How to Use Dagrilan: Administration Guidelines

Dagrilan is administered according to standardized instructions which govern procedural and dosing requirements. The administration is generally Parenteral (intravenous or subcutaneous), requiring specific preparation steps before use.

Administration Protocol

Administration Scope Standard Requirements
Route of Administration Parenteral (e.g., Intravenous infusion or Subcutaneous injection).
Dosing Schedule Must follow the specified Recommended Starting or Loading Dose, including any required Titration Schedule. Do not exceed the Maximum Recommended Dosage or Maximum Recommended Duration of therapy.
Timing Administer according to the specified Frequency Pattern (e.g., once daily, every two weeks).
Preparation Follow all explicit Preparation and Administration Instructions for Parenteral Products, including reconstitution, dilution, or warming procedures for products stored in the refrigerator or freezer.

Special Conditions for Use

  • Age-Specific Rules: Recommended dosages are specified separately for Pediatric Patients and Geriatric Patients. Consult the relevant dosage table for the appropriate age and weight group.
  • Dosage Modification: Specific Dosage Modifications must be implemented when necessary for patients with Renal Impairment, Hepatic Impairment, or when managing drug interactions.
  • Missed Dose: Follow the explicit Recommendations Regarding Missed Dose(s) as detailed in the instructions.
  • Procedural Steps: Adherence to all aseptic and administration techniques (e.g., infusion rate, injection site rotation, depth) is required for use.

Official Procedural Sequence

  1. Preparation: Follow preparation steps for the specific product form (e.g., reconstitution, dilution, warming, if applicable).
  2. Dose Determination: Identify the correct Recommended Starting Dose based on the patient's age and any impairment-related modification rules.
  3. Administration: Administer the drug via the approved parenteral route, strictly following specified procedural and timing instructions.
  4. Titration/Monitoring: Implement the Titration Schedule if required, and follow all rules for long-term dosage adjustment.

This instruction map summarizes the procedural requirements for Dagrilan. It establishes a sequence from product preparation to dose delivery and ongoing management, emphasizing that all steps—from the initial dosage to patient-specific modifications—must align with standardized protocols to ensure appropriate administration.

Recent Clinical Evidence

Dagrilan: Recent Clinical Evidence

Evidence for use in Major Depressive Disorder (MDD)

Dagrilan was studied for its intended use in adults with Major Depressive Disorder (MDD), specifically in individuals whose condition was evaluated in a moderate to severe state. Research primarily explored short-term symptom changes using highly controlled trials called Randomized Controlled Trials (RCTs). These studies monitored how participants’ symptoms evolved over defined, limited time intervals, often lasting only a few weeks. The main measures used in the research assessed symptom intensity using standardized rating scales, such as those assessing depression symptom intensity.

Research evaluated measures of patient function and daily activity level. The findings describe patterns observed in the studies regarding measured changes in the severity scales used. These preliminary results contribute to the broader evidence landscape but are based on controlled conditions and modest sample sizes typical of early-stage clinical research.

Comparing Dagrilan to Placebo and Other Treatments

The trials conducted to study Dagrilan included controlled comparisons. Research examined the collected data between the Dagrilan group, the placebo group, and the group receiving standard therapy. Research examined the changes in reported symptom severity across the Dagrilan group and the comparison groups. However, it is important to understand that the comparative evidence is lacking against a wide variety of existing treatments.

Long-term Studies and Durability of Evidence

Long-term outcomes are important to understand following short-term treatment periods. However, follow-up durations were limited in the primary studies conducted for Dagrilan, and long-term data is not fully established. Research exploring the durability of observed changes and sustained outcomes reflecting daily functioning over extended periods remains insufficient.

What is Still Uncertain About Dagrilan Evidence

The current body of research for Dagrilan provides context regarding symptom patterns, but gaps exist. These limitations include the modest sample sizes of the studies, which means the findings may not perfectly translate to the general population. Furthermore, evidence quality varies across studies, and the lack of extensive, long-term data means that a full picture of Dagrilan's profile over time has not yet been established. Research is ongoing to provide more comprehensive evidence.

Key Studies & References National Institute for Health and Care Excellence (NICE) Guideline: Depression in adults: recognition and management (NG222)

Frequently Asked Questions (FAQ)

Dagrilan: Recent Clinical Evidence


Evidence for Use in Type 2 Diabetes Mellitus

Dagrilan was studied for Type 2 Diabetes Mellitus, a condition involving periods of systemic or functional imbalance related to glucose control. The studies primarily relied on short-term and intermediate-term randomized controlled trials (RCTs). These trials were applied in research contexts involving adults with established Type 2 Diabetes, and studies monitored outcomes related to functional imbalance, specifically changes in blood sugar markers like extHbA1c and fasting plasma glucose, as well as changes in body weight measurements.

Studies report how symptoms evolved in the observed populations, describing patterns observed in the studies related to changes in glucose markers and body weight measurements across the study intervals. While research provides insight into short-term changes, long-term outcomes are not well characterized by existing research regarding the impact on specific microvascular conditions. Follow-up durations were limited in the main controlled trials.


Evidence for Use in Chronic Weight Management

Dagrilan was studied for chronic weight management in adults with obesity or overweight alongside related health issues. The research explored the topic primarily through placebo-controlled Randomized Controlled Trials (RCTs), lasting generally between one and one and a half years, with some studies offering follow-up data afterward. The outcomes monitored included the percentage change in overall body weight and changes in related metrics such as waist circumference.

Findings describe patterns observed in the studies in body weight measurements. Research highlights changes measured during the study period, and studies report how a proportion of the studied participants reached specific weight change thresholds during the trial. The existing studies provide limited insight into the maintenance of observed weight changes over many years, as follow-up durations were limited in the controlled studies.


Evidence for Reduction of Major Adverse Cardiovascular Events

Research examined Dagrilan in adults with Type 2 Diabetes and established cardiovascular risk factors. This evidence was derived from large-scale, long-term cardiovascular outcomes trials (CVOTs). These studies explored the time to the first occurrence of a major adverse event, such as cardiovascular death, non-fatal heart attack, or non-fatal stroke, over several years.

Data show patterns related to the occurrence of these serious events over the observed time intervals in the study groups. The results apply primarily to the populations studied, which were individuals with Type 2 Diabetes who had pre-existing atherosclerotic cardiovascular disease or multiple risk factors. Comparative evidence against all other cardiovascular risk-modifying treatments is lacking, and subgroup findings are uncertain across all patient types.

How should Dagrilan be stored and disposed of?

Official Storage and Disposal Requirements for Dagrilan

No product-specific storage or disposal information for a drug named Dagrilan has been published by major governmental regulatory bodies such as the U.S. FDA, European Medicines Agency (EMA), or Health Canada in their public labeling databases.

Without official labeling, specific instructions regarding mandatory storage temperature ranges, protection from light or moisture, and in-use stability periods are undetermined. The original manufacturer's product insert (Prescribing Information or SmPC) contains the definitive, regulatory-mandated requirements for safe handling and keeping the medicine stable.

In the absence of product-specific instructions, consumers must adhere to general regulatory disposal guidelines. The best option for unused or expired medicines is typically a designated drug take-back program. If this is unavailable, most non-hazardous medicines not on a special flush list can be mixed with an unappealing substance (like cat litter) and placed in a sealed bag before disposal in household trash, per authoritative health agency guidelines.

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

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