Clomipramine Side Effects

Some side effects of clomipramine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to clomipramine: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking clomipramine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• rapid heart rate, tremors or shaking;

• confusion, extreme fear, thoughts of hurting yourself;

• agitation, hallucinations, fever, overactive reflexes, vomiting, diarrhea, loss of coordination, fainting;

• painful or difficult urination;

• very stiff (rigid) muscles;

• seizure (convulsions), or

• tired feeling, weakness, easy bruising or bleeding (nosebleed, bleeding gums), pale skin, feeling light-headed or short of breath.

Common side effects may include:

• dry mouth, nausea, upset stomach, loss of appetite, constipation;

• feeling anxious, restless, dizzy, drowsy, or tired;

• sleep problems (insomnia);

• appetite or weight changes;

• memory problems, trouble concentrating;

• increased sweating, numbness or tingling;

• vision changes; or

• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to clomipramine: oral capsule

Nervous system

Nervous system side effects including drowsiness, dizziness, sedation, and headache have been reported frequently. Anticholinergic effects have been reported frequently and include dry mouth, blurry vision, constipation, and urinary retention. Tremor, delirium, akathisia, a tardive dyskinesia- like syndrome, myoclonus, motor hyperactivity during sleep, sleep abnormalities, dystonic reactions, Tourettism, and seizures have also been reported.

Where a primary reason for discontinuation could be identified, most patients discontinued because of nervous system complaints (5.4%), primarily somnolence.

One study has suggested that sedation may occur in 87% of treated patients.

The manufacturer reports that the cumulative incidence of seizures during premarketing testing averaged 0.64% at 90 days and 1.45% at 365 days.

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Cardiovascular

Cardiovascular side effects that have been associated with the use of tricyclic antidepressants have included orthostatic hypotension, tachycardia, QRS widening, other conduction abnormalities, malignant arrhythmias, and malignant hypertension.

Both antiarrhythmic and proarrhythmic effects have been reported in association with tricyclic therapy.

One study of the cardiovascular effects of clomipramine in 26 depressed patients suggested that clomipramine may produce variable and complex cardiac effects. The authors concluded that the drug is "generally well tolerated but it does present some degree of risk for the heart".

Caution should be exercised if clomipramine must be used in patients with cardiovascular disease.

Psychiatric

Psychiatric side effects with use of this drug have included mania and hallucinations. Suicidal ideation, paradoxical aggressiveness, and mental status changes have also been reported with use of clomipramine and other tricyclic antidepressants.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, dry mouth, and constipation.

A study of 26,005 antidepressant users has reported 3.6 times more upper GI bleeding episodes with the use of SSRI's relative to the population who did not receive antidepressant medications. Upper gastrointestinal tract bleeding was observed in 2.3 times more frequently in patients receiving clomipramine.

Where a primary reason for discontinuation could be identified, the second most frequent reason for discontinuation was digestive system complaints (1.3%), primarily nausea and vomiting.

General

General side effects including increased appetite and weight gain have been associated with the use of clomipramine.

Other

Other side effects including withdrawal reactions involving both rebound worsening of preexisting psychiatric conditions and physiologic symptoms have been reported. Abrupt discontinuation may result in symptoms of withdrawal (such as nausea, headache, malaise, irritability and generalized CNS stimulation). Specific physiologic withdrawal symptoms may include nervousness, anxiety, restlessness, akathisia, nausea, malaise, sweating, salivation and seizures. Tachycardia has also been reported.

In one retrospective chart review of 352 patients who were supervised during tapering and discontinuation from serotonin reuptake inhibitor therapy, dizziness, lethargy, paresthesia, nausea, vivid dreams, irritability, and lowered mood were the most common symptoms reported. Patients with at least on qualitatively new symptom were defined in the clomipramine group at a rate of 30.8%.

Genitourinary

Decreased nocturnal penile tumescence and delayed ejaculation have been reported.

One report has suggested that cyproheptadine may be beneficial in the treatment of clomipramine- induced anorgasmia.

Cases of spontaneous orgasm associated with yawning and clomipramine therapy have been reported.

Genitourinary side effects have been reported frequently and have included sexual dysfunction (involving anorgasmia, impotence and decreased libido). Urinary retention has also been reported.

Hematologic

Hematologic side effects have been rare and have included agranulocytosis and pancytopenia.

Endocrine

Endocrine side effects including hyponatremia (in association with the syndrome of inappropriate secretion of antidiuretic hormone) have been reported rarely. Hyperprolactinemia, galactorrhea and secondary amenorrhea have also been reported. A case of pancreatitis associated with clomipramine overdose has been reported.

Following the ingestion of 750 mg to 1,500 mg of clomipramine, a 48 year old female patient developed acute chemical pancreatitis and subsequent abdominal ileus. Serum lipase levels were elevated to 2,546 international units at one point, with a concomitant serum amylase of 112 international units. Two weeks after discontinuing clomipramine and resting the patient's gastrointestinal tract, the ileus and pancreatitis had resolved.

Hepatic

Hepatic side effects have been rare and have included elevated liver function tests and drug-induced hepatitis.

Dermatologic

Dermatologic side effects have included sweating (common) and drug eruptions, photosensitivity, and contact allergy (rare).

Other

Other side effects including neuroleptic malignant syndrome have been reported. One case of neuroleptic malignant syndrome in association with clomipramine (20 mg/day) has been reported. Symptoms including sweating, pyrexia, muscle rigidity, and urinary incontinence resolved with 48 hours after discontinuation of clomipramine and recurred upon rechallenge.

Metabolic

Metabolic side effects including dyslipidemia have been reported. Dyslipidemia (i.e., hypercholesterolemia, hypertriglyceridemia) was reported in a patient receiving clomipramine 150 mg daily. A case of clomipramine-induced diabetes has also been reported.

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