Anafranil

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Anafranil

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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 Anafranil

Property Description
Active ingredient Clomipramine Hydrochloride
Form Oral Tablets (immediate and sustained-release), Capsules, Injectable Solution
Pharmacological class Tricyclic Antidepressant (TCA)
Origin Synthetic Compound (Dibenzazepine Derivative)

Clomipramine Hydrochloride: Identity and Classification

Anafranil is a prescription-only synthetic psychotropic agent whose active component is Clomipramine Hydrochloride. This medicine is structurally identified as a Dibenzazepine derivative and belongs to the pharmacological category of Tricyclic Antidepressants (TCAs). As a first-generation antidepressant, the TCA class has been clinically recognized for its efficacy across various complex mood disorders. The drug is primarily manufactured as oral tablets and capsules, with forms including both immediate-release and specialized sustained-release preparations. Its long-standing inclusion on the World Health Organization’s List of Essential Medicines signifies its established global therapeutic value.

What is the General Action and Purpose of Anafranil?

The general purpose of Anafranil is to support the brain's ability to stabilize mood and regulate emotional processes. It functions as a potent inhibitor of the neuronal reuptake of two key chemical messengers: Serotonin and Norepinephrine. This dual mechanism leads to increased availability of these neurotransmitters, helping to correct certain chemical imbalances in the brain. Clomipramine possesses a unique dual-action profile among older agents, which is valuable when addressing complex cases that require modulation of both pathways.

Summary of Anafranil's Core Characteristics

Anafranil is fundamentally a synthetic compound administered primarily via the oral route, belonging to the TCA class. Its core function is to support the brain's natural mood regulation processes by chemically modulating the availability of Serotonin and Norepinephrine in the synaptic space.

Regulatory References

  1. WHO Essential Medicines List
  2. MedlinePlus: Clomipramine

What side effects are possible with Anafranil?

Possible side effects and safety information

The safety profile for Clomipramine Hydrochloride (Anafranil) is categorized based on incidence rates documented in official regulatory sources, with effects grouped by the physiological system involved.

Frequency-Classified Adverse Reactions

The most frequent effects are classified as Very Common (ge 10%) and include Somnolence, Tremor, Dizziness, Dry mouth, Constipation, Nausea, Fatigue, and Sexual dysfunction. Common effects (1% to < 10%) include Weight gain, Insomnia, Anxiety, and Sinus tachycardia. Less frequent, or Uncommon effects (0.1% to < 1%), include more serious events like Convulsions (Seizures) and Arrhythmias. Rare events (0.01% to < 0.1%) cover system-wide issues such as severe Hepatitis or Agranulocytosis.


Serious Safety Considerations

Regulatory documentation highlights serious adverse reactions that require close monitoring. These include the risk of Suicidal ideation and behavior, especially in children, adolescents, and young adults (under 25), and a risk of severe Cardiac Arrhythmias (e.g., QTc prolongation), which is a major concern for the drug class. The label also notes the potential for Serotonin Syndrome and Neuroleptic Malignant Syndrome (NMS).


Population and Time-Related Safety Patterns

Specific safety statements apply to certain patient groups. Older Adults are particularly susceptible to the drug’s Anticholinergic and Cardiovascular effects (like postural hypotension). The risk of Suicidal risk may be heightened during the initial phase of treatment or following dose adjustments. Use is strictly limited in individuals with known severe Cardiac Conduction Defects or recent Myocardial Infarction.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information for Anafranil

An overdose of Clomipramine Hydrochloride is classified in regulatory documents as a life-threatening medical emergency that can be fatal. Immediate emergency medical attention is required for any suspected overdose due to the rapid onset of severe toxicity.

Documented Manifestations and Severe Outcomes

Overdose primarily involves the central nervous system (CNS) and the cardiovascular system. Documented signs include seizures, coma, extreme drowsiness, confusion, and agitation. Cardiovascular toxicity may present as irregular heartbeats, QTc prolongation, and potentially Torsades de Pointes. The presence of Serotonin Syndrome is also a documented risk. The danger of overdose is notably increased when the substance is ingested with multiple drugs, including alcohol. Regulatory labeling also notes that overdose is particularly dangerous in young children.

Emergency Actions and Required Monitoring

There is no specific antidote known for Clomipramine overdose. Regulatory authorities mandate that individuals must seek emergency medical attention immediately by contacting emergency services or a poison control center. Treatment is restricted to general supportive and symptomatic measures under continuous hospital observation. Required monitoring includes surveillance of the cardiac rhythm and vital signs.

Therapeutic Uses of Anafranil

Clomipramine is commonly used across domains where additional symptomatic support is needed. The medication's uses span several key therapeutic areas.

The medication is commonly used to help manage the symptom clusters of Obsessive-Compulsive Disorder (OCD). It is also considered relevant for the management of severe Major Depressive Disorder, and for specialized symptomatic support in conditions like Cataplexy (sudden muscle weakness) associated with narcolepsy, and certain chronic nerve-related pain syndromes.

In clinical settings where symptoms are functionally impairing, Anafranil is applied in scenarios where additional management of discomfort is required. It plays a role in managing symptoms related to intrusive thoughts and compulsive behaviors, and may assist with maintaining functional stability during phases when symptoms become more noticeable.

Quick Fact: Symptomatic Support for Intrusive Thoughts Anafranil is primarily used to address the patterns of recurrent, unwanted obsessions that interfere with daily functioning, assisting with maintaining functional stability.

Regulatory References

  1. NIH StatPearls clinical overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Anafranil?

Eligibility for Anafranil (Clomipramine) is defined by official regulatory criteria established in governmental labeling, focusing on age, concurrent medical conditions, and other drug use. The medicine is primarily approved for adults and children aged 10 years and older for the treatment of Obsessive-Compulsive Disorder (OCD), with restrictions applying to various populations.


Absolute Contraindications

Anafranil is contraindicated and must not be used by patients with known hypersensitivity to clomipramine or other Tricyclic Antidepressants (TCAs). It is also strictly contraindicated for patients currently taking, or who have recently taken (within 14 to 21 days), a Monoamine Oxidase Inhibitor (MAOI), and during the acute recovery period following a Myocardial Infarction (MI).

Population Restrictions

Population Group Regulatory Status
Children under 10 Safety and efficacy not established
Older Adults Use with caution; requires close monitoring
Pregnancy/Lactation Not recommended; use only if benefit outweighs risk
Hepatic/Renal Impairment Use with caution; requires monitoring

Eligibility is limited for certain age groups, including young adults (ages 18–24) who require close monitoring due to increased risk of suicidal thinking. In populations with severe hepatic or renal impairment, use is permitted only with explicit caution and regular clinical monitoring, as documented in the prescribing information.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Anafranil (Clomipramine Hydrochloride) has officially documented interactions structured by both pharmacokinetic (PK) and pharmacodynamic (PD) effects, resulting in specific use restrictions in government regulatory documents.

Interaction Classifications

Classification Basis Relevant Entities
Contraindicated Combinations PD Reinforcement Monoamine Oxidase Inhibitors (MAOIs), Pimozide, Thioridazine, Dronedarone, and other QTc-prolonging agents.
Exposure-Modifying PK Inhibition Strong CYP2D6 inhibitors (e.g., Fluoxetine, Paroxetine) and CYP1A2 inhibitors (e.g., Fluvoxamine).

Official Interaction Statements

  • MAOIs are strictly prohibited for co-administration due to the risk of Serotonin Syndrome and hypertensive crisis. A 14-day separation period is mandatory when switching between an MAOI and Anafranil.
  • Co-administration with Fluoxetine requires a separation period of at least five weeks before starting Anafranil due to the long half-life of its active metabolite, which acts as a CYP2D6 inhibitor.
  • Combining with other serotonergic agents (e.g., Triptans, Tramadol, St. John's Wort) increases the officially documented risk of Serotonin Syndrome.
  • Concomitant use with drugs that prolong the QTc interval is contraindicated due to the increased risk of serious ventricular arrhythmias.
  • The CNS depressant effects of Anafranil may be enhanced by co-administration with substances such as alcohol.
  • The regulatory profile notes that individuals classified as CYP2D6 Poor Metabolizers naturally exhibit increased plasma concentrations of Clomipramine, raising the systemic exposure and subsequent interaction risk.

Mechanism of Action

Clomipramine, a tricyclic compound, exerts its pharmacodynamic effects by operating across multiple neuronal pathways to modify neurotransmitter activity. Its core mechanism involves a primary action on reuptake, complemented by receptor antagonism.


Dual Neurotransmitter Reuptake Modulation

This domain focuses on clomipramine's ability to block the reabsorption (reuptake) of two key monoamine neurotransmitters, serotonin (5-HT) and norepinephrine (NE), into the presynaptic neuron. The selective reuptake inhibition by clomipramine and its active metabolite, desmethylclomipramine, results in an increased local concentration of these mediators in the synaptic cleft.

This action drives a modulated profile of neurotransmitter activity within relevant pathways of the central nervous system.


Receptor-Mediated Pathway Engagement

Beyond transporter inhibition, clomipramine and its metabolites function as antagonists on several specific receptors, including muscarinic cholinergic ( M1), histaminergic ( H1), and alpha1-adrenergic receptors. These secondary interactions engage different signaling cascades within the nervous system. This broader engagement contributes to the functional shift of signaling within targeted pathways toward a modified state of activity.

Dosage and Administration Information

Official Administration Guidelines

Anafranil (Clomipramine Hydrochloride) is primarily administered via the oral route using capsules or tablets, establishing the standard method of intake. The official dosing structure is phased, starting with a low dose that is gradually increased over several weeks, known as titration, to determine the effective maintenance level. While intramuscular (IM) injection is referenced as an absorbed route, oral administration remains the established standard of use.

Parameter Official Dosing and Administration
Initial Starting Dose (Adults) 25 mg daily, typically taken in divided portions with meals during the titration phase.
Maintenance Dose Once maintenance is reached, the total daily amount may be consolidated and administered once daily at bedtime to minimize potential daytime effects.
Maximum Recommended Dose The maximum adult daily intake is 250 mg.
Duration Context Patients on continuation treatment require periodic reassessment to ensure the lowest effective dosage is maintained, as efficacy beyond 10 weeks has not been systematically established.

Population-Specific Dosing Rules

Official guidelines require significant modifications for certain groups:

  • Older Adults (Geriatric): Treatment should initiate with a lower dose (e.g., 10 mg daily), with slow, cautious increments up to a typical maximum range of 30 mg to 75 mg daily.
  • Pediatric Patients (OCD ge 10 years): The initial dose is 25 mg daily. The maximum dose is limited to the smaller of 3 mg/kg/day or 200 mg/day.

This protocol defines the necessary procedural steps for using the drug, ensuring controlled initiation, establishment of an appropriate maintenance dose, and adherence to specific intake timing relative to meals and bedtime.

Recent Clinical Evidence

Clomipramine hydrochloride (Anafranil), a tricyclic antidepressant (TCA), has been authorized for the treatment of Obsessive-Compulsive Disorder (OCD) in patients aged 10 and older. It was the first medication of its class to receive this authorization.

Core Clinical Efficacy

Clinical effectiveness for OCD was demonstrated in multi-center, placebo-controlled trials. In these studies, adult patients with moderate-to-severe OCD receiving clomipramine experienced an average improvement ranging from 35% to 42% on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the standard measure for symptom severity. Studies in children and adolescents (ages 10-17) reported similar average improvements of approximately 37% on the same scale, compared to minimal response in the placebo groups.

Comparative Findings

Recent meta-analyses evaluating clomipramine against selective serotonin reuptake inhibitors (SSRIs) for OCD have found some evidence suggesting clomipramine's effectiveness may be equivalent or slightly greater than certain SSRIs. However, due to the generally more favorable side effect profile associated with SSRIs, they are often considered a preferred initial treatment approach.

Research in Treatment-Resistant Cases

Research has explored alternative administration routes, such as intravenous (IV) pulse loading of clomipramine, particularly for patients whose OCD has been resistant to oral medications. Some studies have noted a potentially more rapid response in symptom reduction with the IV approach, though the clinical settings for this method are highly specific. The combination of clomipramine with specific psychotherapies, such as Exposure and Response Prevention (ERP), has also been shown to be effective for some individuals with OCD.

Frequently Asked Questions (FAQ)

Common questions about Anafranil (FAQ)

Q: What is Anafranil and what is it used for?

Anafranil is the brand name for the medication clomipramine, which belongs to a class of drugs called tricyclic antidepressants (TCAs).

It is FDA-approved primarily for the treatment of Obsessive-Compulsive Disorder (OCD) in adults and children 10 years and older. It helps reduce repetitive, unwanted thoughts (obsessions) and the need to perform certain routines (compulsions). Clomipramine is also sometimes used off-label for other conditions, such as panic disorder or chronic pain, when decided by a healthcare provider.


Q: How long does it take for Anafranil to start working for OCD?

Like many medications used to treat OCD, Anafranil does not work instantly. Some people may start to notice minor improvements in their symptoms within the first 1 to 3 weeks of starting treatment.

However, it can take 8 to 12 weeks (2 to 3 months) to experience the full therapeutic effects and see the greatest reduction in obsessive and compulsive behaviors. It is important to continue taking the medication exactly as prescribed, even if you do not feel better right away.


Q: What are the common side effects of Anafranil?

Anafranil is known to have a number of potential side effects, especially during the initial weeks of treatment. Common side effects often include:

  • Dry mouth (a very frequent side effect)
  • Drowsiness or sedation
  • Dizziness
  • Constipation
  • Blurred vision
  • Nausea
  • Tremors (shaking)
  • Weight gain
  • Sexual dysfunction (e.g., difficulty achieving orgasm or changes in libido)

If any side effects are severe or persistent, you should discuss them with your healthcare provider.


Q: Can I stop taking Anafranil suddenly?

No, you should never stop taking Anafranil suddenly or without first talking to your healthcare provider. Abruptly stopping this medication can lead to withdrawal symptoms (also called discontinuation syndrome).

Withdrawal symptoms can include:

  • Dizziness and lightheadedness
  • Nausea
  • Vomiting
  • Headache
  • Sleep disturbances (e.g., vivid dreams, insomnia)
  • Anxiety and irritability
  • Flu-like symptoms (e.g., sweating, chills)

When it is time to stop treatment, your healthcare provider will create a plan to gradually reduce your dose over a period of time. This process is called tapering and helps minimize withdrawal symptoms.


Q: Does Anafranil cause weight gain?

Yes, weight gain is a reported and relatively common side effect of Anafranil (clomipramine), as it is with many other tricyclic antidepressants. The amount of weight gained can vary significantly from person to person.

If you are concerned about weight changes while taking this medication, speak with your healthcare provider. They may suggest lifestyle adjustments, such as changes to diet and exercise, or monitor your weight closely throughout treatment.

How should Anafranil be stored and disposed of?

Official Storage and Disposal Requirements

Anafranil (clomipramine hydrochloride) must be stored strictly according to regulatory labeling to maintain stability and effectiveness.

Storage Conditions

Requirement Official Instruction
Temperature Store at controlled room temperature (e.g., below 25 C or 30 C).
Environment Keep away from excess heat, moisture, and light. Do not store in a bathroom.
Protection Keep from freezing and do not store above the stated maximum temperature.
Packaging Keep the medicine in its original container, tightly closed, and in the original package until ready to use.

Disposal and Safety

Unused or expired Anafranil must be disposed of promptly. Do not discard medication in the household trash or by pouring it down a sink or toilet. Consult a pharmacist or authorized local collection program for proper disposal methods. Ensure the medication is kept out of the reach and sight of children at all times.

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

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