Дулоксетин

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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 Дулоксетин

Quick Facts

Property Description
Active ingredient Duloxetine hydrochloride
Form Delayed-Release Oral Capsules
Pharmacological class Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Route of administration Oral
Origin Synthetic organic compound

What Type of Drug is Дулоксетин and How is it Classified?

Дулоксетин is a synthetic organic compound that is classified pharmacologically as a Serotonin-Norepinephrine Reuptake Inhibitor (SNRI), available exclusively as a prescription-only medicine. Its active constituent is Duloxetine hydrochloride, which functions specifically as the pharmacologically active S-enantiomer of the chemical compound. Duloxetine acts as a potent dual inhibitor of serotonin and norepinephrine reuptake. This dual-action approach is clinically recognized for its broad applicability in regulating central nervous system signaling pathways, establishing a key differentiation point from older, single-system antidepressants.

The Composition and Specialized Form of Duloxetine

The medication is a single-ingredient product designed for oral administration, specifically formulated as Delayed-Release Capsules. This dosage form is critical because the active ingredient, Duloxetine, is acid-labile and can be degraded by stomach acid. The capsules therefore contain enteric-coated pellets, preventing their dissolution until they reach the intestine, which is essential for proper absorption. The pharmaceutical engineering behind the delayed-release mechanism ensures the consistent delivery required for chronic maintenance therapy.

What is the General Purpose of Dual Reuptake Inhibition?

The general purpose of Duloxetine’s unique dual reuptake inhibition mechanism is to promote better chemical communication by increasing the functional availability of two key neurotransmitters: serotonin and norepinephrine. By blocking the natural reuptake of these messengers by the nerve cells, the drug helps to restore balance in the central nervous system. This enhancement in signaling pathways is the core mechanism underlying the drug’s general role in helping to regulate complex emotional states and modulating the body's processing of pain signals, which is typical for compounds with combined serotonergic and noradrenergic activity.

Regulatory References

  1. Duloxetine (Cymbalta) EMA EPAR Summary

What side effects are possible with Дулоксетин?

Possible Side Effects and Safety Information

The safety profile of Duloxetine, classified as a Serotonin-Norepinephrine Reuptake Inhibitor, is structured by government regulatory documents based on frequency and the body system affected. The most frequently reported adverse reactions, categorized as Very Common in official SmPC documents, include Nausea, Dry mouth, Headache, and Somnolence (drowsiness). Reactions classified as Common include fatigue, insomnia, dizziness, constipation, and increased sweating.

Adverse effects are formally grouped by System-Organ Classes, with high reporting rates observed in the Gastrointestinal disorders (e.g., nausea, dry mouth), Nervous system disorders (e.g., headache, somnolence), and Psychiatric disorders (e.g., anxiety, insomnia).

Serious Adverse Reactions and Population Constraints

Official regulatory labeling highlights the potential for several serious adverse reactions. The FDA label includes a Boxed Warning concerning an increased risk of Suicidal Thoughts and Behaviors in children, adolescents, and young adults during the initial treatment phase or following dose adjustment. Rare but serious reactions documented in official texts include Serotonin Syndrome and severe Hepatotoxicity, potentially leading to hepatic failure.

Safety constraints define specific usage limitations. The use of the medicine is contraindicated in patients with severe hepatic impairment (liver disease) and with uncontrolled narrow-angle glaucoma. Furthermore, it should not be used concurrently with Monoamine Oxidase Inhibitors (MAOIs). For patients with severe renal impairment, use is generally not recommended, reflecting population-specific safety notes defined in the official prescribing information.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes that an overdose of duloxetine (Дулоксетин) may lead to serious clinical manifestations, including severe central nervous system and cardiovascular effects.

Documented Signs and Symptoms

Symptoms reported in association with duloxetine overdose include:

  • Central Nervous System (CNS) Effects: Somnolence, seizures, and coma.
  • Cardiovascular Effects: Tachycardia and syncope.
  • Gastrointestinal Effects: Vomiting.
  • Serotonin Syndrome: Overdose can precipitate Serotonin Syndrome, a potentially life-threatening condition.

Overdose Risks and Emergency Action

Fatal outcomes have been reported following acute duloxetine overdoses, particularly when the drug was ingested in combination with other substances (mixed drug ingestions). Although rare, fatalities have also occurred with duloxetine alone, with reported doses as low as approximately 1000 mg.

If an overdose is suspected, immediate emergency medical attention is required.

  1. Seek Urgent Medical Help: Contact a poison control center for current, detailed information on the management of overdosage.
  2. Supportive Care: Management in a medical setting involves providing supportive care, with monitoring of vital signs and close observation. An adequate airway, oxygenation, and ventilation should be established as needed. No specific antidote is known for duloxetine overdose.
  3. Multiple Drug Ingestion: Healthcare professionals must consider the possibility of multiple drug involvement during the management of any suspected overdose.

Therapeutic Uses of Дулоксетин

The therapeutic domains of use are generally categorized across major areas, including mood disorders, anxiety, and chronic pain. The primary purpose is to provide supportive relief when symptoms interfere with daily functioning and contributes to supporting the overall symptom load.

The medication is commonly used to help manage symptoms related to Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), nerve damage pain (Diabetic Peripheral Neuropathic Pain), and chronic widespread pain conditions like Fibromyalgia (FMS).

Chronic Pain Syndromes and Neuropathic Discomfort

This domain is commonly used across conditions characterized by periods of heightened symptoms, such as the centralized pain of Fibromyalgia and symptoms related to nerve damage. It is relevant for supporting challenging sensations like burning or shooting pain, which supports general well-being during symptomatic phases.

Management of Persistent Mood and Anxiety Symptoms

This is applied across domains where additional symptomatic support is needed for conditions like MDD and GAD. It is applied in addressing symptom clusters related to persistent low mood, excessive worry, and physical tension, offering symptomatic relief that helps patients cope more steadily with their manifestations.

Quick Fact: Relief for Chronic Discomfort
Primary Focus: Managing persistent, clinically significant symptoms across emotional and physical domains.
Symptom Type: Neuropathic pain (burning, shooting), widespread chronic musculoskeletal pain, and generalized excessive worry.
Goal: Provides support that supports the patient during difficult episodes by easing distress and assists with supporting functional stability.

Eligibility and Restrictions for Use

Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults for all approved indications. Pediatric use is established for Generalized Anxiety Disorder (mathbfgeq 7 years) and Fibromyalgia (mathbfgeq 13 years), depending on the regulator.
Populations for whom use is not recommended Children and adolescents under 18 years for Major Depressive Disorder (MDD). Nursing mothers (use requires caution, as the drug is excreted into breast milk).
Populations for whom use is contraindicated Patients currently taking a Monoamine Oxidase Inhibitor (MAOI), or within 14 days of discontinuing one. Patients with liver disease resulting in hepatic impairment or severe renal impairment (Creatinine Clearance < 30 mL/min). Patients with uncontrolled narrow-angle glaucoma or uncontrolled hypertension.

Age-Related Eligibility: The medicine is established for adults. Use in the elderly requires caution, but no dosage adjustment is recommended solely based on age. Pediatric use for MDD is not generally recommended.

Condition-Specific Eligibility: In addition to severe organ impairment, use is restricted in patients with a history of mania/bipolar disorder or seizure disorder, requiring cautious prescription. The medication is also not recommended for patients with specific hereditary sugar intolerances (due to capsule excipients).

Pregnancy and Lactation Eligibility: Use during pregnancy is advised only if the potential benefit justifies the potential risk to the fetus (US FDA older classification: Pregnancy Category C). Use during lactation requires regulatory caution.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Duloxetine is formally defined by pharmacodynamic and pharmacokinetic patterns documented in regulatory sources.

Contraindicated Combinations

Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is formally prohibited due to the significant risk of Serotonin Syndrome. A mandatory separation of at least 14 days is required when switching from an MAOI to Duloxetine, and 5 days when switching from Duloxetine to an MAOI. The combination with Thioridazine is also contraindicated, as Duloxetine is a moderate inhibitor of the CYP2D6 enzyme.

Pharmacokinetic and Pharmacodynamic Interactions

Duloxetine clearance is inhibited by Potent CYP1A2 Inhibitors (e.g., Fluvoxamine, Ciprofloxacin). This pharmacokinetic interaction can increase Duloxetine plasma concentration by up to five-fold and co-administration is discouraged. The risk of Serotonin Syndrome is increased when Duloxetine is combined with other serotonergic agents or triptans due to additive pharmacodynamic effects. Use with medications that interfere with hemostasis (e.g., NSAIDs, Aspirin) increases the documented risk of bleeding events.

Substance and Population Restrictions

Duloxetine is ordinarily not recommended for patients with chronic liver disease or severe renal impairment because reduced clearance in these populations increases systemic exposure and interaction potential. Substantial regular alcohol use is associated with an increased risk of severe liver injury and ordinarily contraindicates treatment.

Mechanism of Action

Dual Neurotransmitter Potentiation

The drug's primary action is to inhibit the reabsorption (reuptake) of two key neurotransmitters, Serotonin (5-HT) and Norepinephrine (NE), back into the presynaptic nerve terminals. By binding to and blocking the Serotonin Transporter ( SERT) and the Norepinephrine Transporter ( NET) , Duloxetine increases the effective concentration and duration of both signaling chemicals in the synaptic space, leading to increased signaling across affected neural circuits.

Modulation of Central Pain Signaling

This increased neurotransmission primarily affects the Descending Pain Inhibitory Pathway, a regulatory system that originates in the brain and projects down the spinal cord. Increased levels of Serotonin and Norepinephrine strengthen the inhibitory signal on nociceptive pathways, contributing to the functional suppression of pain signal transmission in the dorsal horn of the spinal cord.

Regulation of Somatic Muscle Tone

The mechanism extends to the lower spinal cord where increased monoamine stimulation affects the motor neurons controlling the urethral sphincter muscle. This increased neural outflow results in an increase in the muscle's resting tension and contractility.

Dosage and Administration Information

Duloxetine is administered exclusively by the oral route as a delayed-release capsule. This specialized formulation, which contains enteric-coated pellets, requires that the capsule must be swallowed whole and must not be crushed, chewed, or opened to ensure proper absorption and prevent the degradation of the active ingredient by stomach acid. The medicine can be taken with or without food.

Official Dosing and Frequency

The standard administration schedule is once daily, with the exact dose structured by the indication. For many conditions, including Fibromyalgia and Chronic Musculoskeletal Pain, treatment often initiates at 30 mg once daily for a short period before escalating to the recommended maintenance dose of 60 mg once daily. For Major Depressive Disorder and Generalized Anxiety Disorder, starting doses may range up to 60 mg once daily, with a maximum dose of 120 mg per day permitted.

Procedural Administration Rules

Consistency is a key element of the usage protocol; the dose should be taken at approximately the same time each day. In the event of a missed dose, the general instruction is to take the dose as soon as it is remembered unless it is almost time for the next scheduled dose, in which case the missed dose should be skipped entirely. Two doses must never be taken at the same time. Furthermore, use is generally avoided in patients presenting with severe liver disease or end-stage renal disease. Upon cessation, the dosage must be gradually reduced over a period of at least one to two weeks.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Clinical Trials

Duloxetine Efficacy Research

Research has explored duloxetine, and studies have evaluated whether it is associated with reductions in acute inflammation and pain, and included analysis of its activity on a key enzyme.

Research investigated whether the treatment was associated with reductions in joint stiffness and pain relief in patients with osteoarthritis. Study protocols focused on a specified administration schedule.

Research on Populations

Research included evaluation of the drug in most adult populations. Studies did not include clinical advice or guidance.

The drug's use has been examined in people with liver disease, and research noted specific findings related to the liver.

Studies on Combination Therapy

Research has evaluated whether combination therapy with other treatments is associated with a change in overall outcome and investigated the frequency of flare-ups.

Studies have compared duloxetine to other treatments, evaluating outcomes related to pain.

Key Studies & References

  1. Duloxetine - LiverTox - NCBI Bookshelf - NIH
  2. Pregabalin and Duloxetine in Patients with Non-Nociceptive Pain: A Narrative Review Exploring the Pharmacological Effects of This Combination

Frequently Asked Questions (FAQ)

Common questions about Дулоксетин (FAQ)


Q: Are any special checks needed before starting Duloxetine?

According to official product information, for patients with certain pre-existing conditions, such as diabetes or severe kidney impairment, specific preparation may be noted. Regulatory information indicates that in certain patient populations, the healthcare provider may perform baseline checks of organ function or blood sugar levels.

Q: What are the official indications for Duloxetine?

Official regulatory documents describe the medicine's approved uses, or indications. These include Major Depressive Disorder, Generalized Anxiety Disorder, Fibromyalgia, chronic musculoskeletal pain, and pain related to Diabetic Peripheral Neuropathy. In certain regions, it is also approved for the treatment of stress urinary incontinence.

Q: Is it true that Duloxetine is approved for fibromyalgia?

Yes, Fibromyalgia is listed as an official indication for this medicine in regulatory documents. This means the drug is approved for the treatment of this condition.

Q: Why is Duloxetine prescribed for urinary incontinence?

Official regulatory documents confirm that this medicine is approved for the treatment of stress urinary incontinence. Its approved use is attributed to the mechanism that helps modulate the muscles controlling the urethral sphincter.

Q: Do I need to take Duloxetine for a long time to see an effect?

Studies and official clinical trial data indicate that the effects are often gradual. While some measurable improvement may be noted around two weeks, more substantial changes on standardized scales are typically observed after approximately four to five weeks of treatment.

Q: Does Duloxetine interact with painkillers?

Official product information states that caution is advised when taking this medicine with non-steroidal anti-inflammatory drugs (NSAIDs) or Aspirin, as this combination may increase the documented risk of bleeding. Caution is also generally recommended with certain pain relievers that act on the serotonin system.

Q: How does Duloxetine interact with supplements or herbal remedies (e.g., St. John's Wort)?

Regulatory guidance specifically warns against taking the herbal supplement St. John's Wort while on this medicine, as this can increase the risk of serious side effects, such as Serotonin Syndrome. General caution is noted regarding other herbal remedies and supplements.

Q: Can Duloxetine affect driving?

Official patient information warns that this medicine may cause side effects like dizziness or somnolence (drowsiness). Due to these possible effects on mental alertness, official guidance states that individuals experiencing these effects should avoid driving or operating complex machinery.

Q: What is Duloxetine discontinuation syndrome?

When the medicine is stopped, a discontinuation syndrome may occur. Regulatory documents list associated symptoms which can include dizziness, headache, nausea, excessive sweating, and feelings of anxiety. Official guidance requires that the dosage be gradually reduced upon cessation.

Q: Why does Duloxetine sometimes cause dry mouth?

Dry mouth is listed as a very common side effect. This effect is linked to the drug's primary action as a Serotonin-Norepinephrine Reuptake Inhibitor (SNRI), which can influence the nervous system's control over various body functions, including saliva production.

Q: Why does Duloxetine often cause sweating?

Increased sweating is a reported side effect of this medicine. It is believed to be related to the drug's primary action of increasing norepinephrine levels, which in turn can activate the sympathetic nervous system pathways that control the body's sweating response.

Q: Can Duloxetine worsen anxiety at the start of treatment?

Official regulatory information notes that some patients may experience an initial overstimulation syndrome, including increased anxiety, agitation, or restlessness. These effects are most common when first starting the medicine or after a dose adjustment, and they typically lessen over the first few weeks.

Q: Is Duloxetine considered a strong antidepressant?

Duloxetine is classified pharmacologically as a Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). The official mechanism of action describes it as a potent dual inhibitor, meaning it blocks the reuptake of both serotonin and norepinephrine neurotransmitters.

Q: Are Duloxetine and Velaxine (Venlafaxine) the same thing?

No, Duloxetine and Venlafaxine are two distinct pharmaceutical compounds. While they belong to the same drug class, Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), they are different molecules.

Q: Does Duloxetine work immediately after taking it?

Clinical data indicates that the therapeutic effects of the medicine are usually gradual, with measurable improvement typically noted starting around two to four weeks. The medicine is designed for consistent, long-term use, not for immediate effect after a single dose.

Q: Is it true that Duloxetine can affect weight?

Official regulatory documents note that changes in body weight (both increases and decreases) were reported in clinical trials. While a small weight decrease was observed in the initial weeks, longer-term studies showed a modest mean weight gain.

Q: Does Duloxetine affect libido or sexual function?

Yes, the official regulatory labeling for this medicine includes sexual dysfunction as a possible adverse reaction. Reported effects may include decreased libido or other changes in sexual function.

Q: Do I need to change my diet when taking Duloxetine?

No specific diet changes are generally required, and the medicine can be taken with or without food. However, official guidance documents note that the substantial regular use of alcohol while taking this medicine is associated with an increased risk of liver injury.

Q: Can Duloxetine cause dependence?

Antidepressants, including this medicine, are generally not considered addictive but can cause physiological dependence. This means the body adapts to the drug. The dosage must be gradually reduced under professional supervision when the medicine is stopped.

Q: Is there a difference in effect if Duloxetine is taken in the morning or evening?

Official prescribing information notes differences in how the body processes the medicine based on the time of day. Specifically, taking the medicine in the evening may result in a delay in its absorption and a change in how the body clears the medicine compared to a morning dose.

Q: Does Duloxetine affect blood test results?

Yes, official safety information indicates that the medicine has been associated with changes in certain blood test results. These changes can include temporary elevations in liver enzymes, as well as an increase in blood glucose and HbA1c levels in diabetic patients.

Q: How does Duloxetine affect blood sugar levels?

For patients with diabetes, regulatory warnings indicate that this medicine has been associated with modest increases in fasting blood glucose levels. This effect can lead to worsened glycemic control, and regulatory information notes that regular monitoring may be appropriate for this patient group.

Q: Can Duloxetine be replaced with a generic?

Yes, the active ingredient, duloxetine, is available in generic form. Generic medicines are approved by regulatory agencies as being therapeutically equivalent to the original brand-name product.

Q: What other names does Duloxetine have?

The active ingredient, duloxetine, is marketed under various brand names in different countries. Commonly recognized international brand names include Cymbalta and Yentreve.

Q: Can Duloxetine cause blurred vision?

Official regulatory patient information includes blurred vision in the list of reported side effects that have been associated with this medicine.

How should Дулоксетин be stored and disposed of?

Storage and Disposal Conditions for Duloxetine

Duloxetine delayed-release capsules must be stored at controlled room temperature, specifically 25 C (77 F), with permitted fluctuations between 15 C and 30 C (59 F and 86 F). The medication must be kept in its original container, tightly closed, and protected from heat, moisture, and freezing.

Due to the specialized enteric coating, the capsule must be swallowed whole and must not be crushed, opened, or chewed. If a specific formulation is opened and mixed with food, the mixture must be swallowed immediately and not stored.

To ensure child safety, the medicine must be stored out of the reach and sight of children.

For disposal of unused or expired product, the official instruction is to utilize a drug take-back program. If one is unavailable, the product should be disposed of in household trash following FDA guidelines, including obscuring personal information on the label.

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

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