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Clomipramine Side Effects

In Summary

Commonly reported side effects of clomipramine include: constipation, dizziness, drowsiness, dyspepsia, ejaculatory disorder, fatigue, headache, insomnia, myoclonus, nausea, nervousness, paresthesia, tremor, urination disorder, visual disturbance, weight gain, anorexia, diaphoresis, and xerostomia. Other side effects include: anxiety, fever, hot flash, hypertonia, memory impairment, muscle twitching, non-puerperal lactation, orthostatic hypotension, pruritus, skin rash, sleep disorder, tachycardia, tinnitus, vomiting, flushing, and taste disorder. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to clomipramine: oral capsule, oral tablet

Along with its needed effects, clomipramine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking clomipramine:

More common
  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • confusion
  • difficult, burning, or painful urination
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • excessive muscle tone
  • fear or nervousness
  • feeling sad or empty
  • fever
  • hearing changes
  • irritability
  • lower back or side pain
  • muscle stiffness, tension, or tightness
  • poor concentration
  • rhythmic movement of muscles
  • sneezing
  • tightness of the chest
  • trouble breathing
  • unusual tiredness or weakness
  • voice changes
Less common
  • Anger that is hard to control
  • breast enlargement
  • burning feeling while urinating
  • changes in vision
  • chills
  • decrease in the frequency of urination
  • difficulty in passing urine (dribbling)
  • difficulty in speaking
  • dry mouth
  • fast, irregular, pounding, or racing heartbeat or pulse
  • headache, severe and throbbing
  • hyperventilation
  • irregular heartbeats
  • irritability
  • nausea or vomiting
  • numbness, tingling, pain, or weakness in the hands or feet
  • pain during sexual intercourse
  • panic attacks
  • paranoia
  • rapidly changing moods
  • restlessness
  • shaking
  • swelling of the face, fingers, feet, or lower legs

Some side effects of clomipramine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • change in taste
  • constipation
  • cracked, dry, or scaly skin
  • change in interest in sexual intercourse
  • diarrhea
  • dry skin
  • heartburn
  • hives or welts, skin rash
  • inability to have or keep an erection
  • increased interest in sexual intercourse
  • joint pain
  • pimples
  • redness of the face, neck, arms, and occasionally, upper chest
  • shakiness in the legs, arms, hands, or feet
  • stomach discomfort, upset, or pain
  • swelling
  • swollen joints
  • trembling or shaking of the hands or feet
Less common
  • Absent, missed, or irregular menstrual periods
  • breast pain
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth

For Healthcare Professionals

Applies to clomipramine: oral capsule

Nervous system

Very common (10% or more): Somnolence (up to 54%), tremor (up to 54%), dizziness (up to 54%), headache (up to 52%), nervousness (up to 18%), myoclonus (up to 13%)
Common (1% to 10%): Paraesthesia, twitching, hypertonia, confusion, speech disorder, migraine, paresis, taste perversion, abnormal thinking, vertigo
Uncommon (0.1% to 1%): Abnormal coordination, abnormal EEG, abnormal gait, ataxia, coma, convulsions, dyskinesia, dysphonia, encephalopathy, euphoria, extrapyramidal disorder, hyperkinesia, hypokinesia, neuralgia, sensory disturbance, somnambulism, stimulation
Rare (less than 0.1%): Cerebral hemorrhage, anticholinergic syndrome, aphasia, apraxia, cholinergic syndrome, choreoathetosis, generalized spasm, hemiparesis, hyperesthesia, hyperreflexia, hypoesthesia, indecisiveness, neuropathy, nystagmus, oculomotor nerve paralysis, stupor
Frequency not reported: Neuroleptic malignant syndrome[Ref]

Cardiovascular

Common (1% to 10%): Flushing, chest pain, postural hypotension, palpitation, tachycardia, syncope
Uncommon (0.1% to 1%): Abnormal ECG, arrhythmia, bradycardia, cardiac arrest, extrasystoles, pallor, increased blood pressure
Rare (less than 0.1%): Cyanosis, aneurysm, atrial flutter, bundle branch block, cardiac failure, heart block, myocardial infarction, myocardial ischemia, peripheral ischemia, thrombophlebitis, vasospasm, ventricular tachycardia[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 25%)
Common (1% to 10%): Anxiety, memory impairment, impaired concentration, depression, sleep disorder, psychosomatic disorder, abnormal dreaming, agitation, depersonalization, irritability, emotional lability, panic reaction, aggressive reaction
Uncommon (0.1% to 1%): Delirium, delusion, apathy, euphoria, catalepsy, illusion, impaired impulse control, mutism, oculogyric crisis, hallucinations, hostility, hypnagogic hallucinations, manic reaction, paranoia, phobic disorder, suicidal ideation, suicide attempt, psychosis
Rare (less than 0.1%): Withdrawal syndrome, schizophrenic reaction[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 84%), constipation (up to 47%), nausea (up to 33%), dyspepsia (up to 22%), diarrhea (up to 13%), abdominal pain (up to 11%)
Common (1% to 10%): Vomiting, flatulence, tooth disorder, gastrointestinal disorder, dysphagia, esophagitis, eructation, ulcerative stomatitis, halitosis
Uncommon (0.1% to 1%): Blood in stool, teeth-grinding, colitis, duodenitis, gastric ulcer, gastritis, gastroesophageal reflux, gingivitis, glossitis, hemorrhoids, increased saliva, irritable bowel syndrome, peptic ulcer, rectal hemorrhage, tongue ulceration, tooth caries
Rare (less than 0.1%): Cheilitis, chronic enteritis, discolored feces, gastric dilatation, gingival bleeding, hiccup, intestinal obstruction, oral/pharyngeal edema, paralytic ileus, salivary gland enlargement[Ref]

General

The most commonly reported side effects were somnolence, tremor, dizziness, headache, dry mouth, constipation, and nausea.[Ref]

Genitourinary

Very common (10% or more): Libido change (up to 21%), micturition disorder (up to 14%), dysmenorrhea (up to 12%)
Common (1% to 10%): Urinary tract infection, micturition frequency, urinary retention, dysuria, cystitis, lactation (nonpuerperal), menstrual disorder, vaginitis, leukorrhea, breast enlargement, breast pain, amenorrhea, ejaculation failure, impotence
Uncommon (0.1% to 1%): Endometriosis, epididymitis, hematuria, nocturia, oliguria, ovarian cyst, perineal pain, polyuria, prostatic disorder, urethral disorder, urinary incontinence, uterine hemorrhage, vaginal hemorrhage
Rare (less than 0.1%): Albuminuria, anorgasmy, breast engorgement, breast fibroadenosis, cervical dysplasia, endometrial hyperplasia, premature ejaculation, pyelonephritis, pyuria, uterine inflammation, vulvar disorder[Ref]

Hematologic

Common (1% to 10%): Purpura, anemia
Uncommon (0.1% to 1%): Lymphadenopathy
Rare (less than 0.1%): Leukemoid reaction, lymphoma-like disorder, marrow depression
Very rare (less than 0.01%): Leucopenia, agranulocytosis, thrombocytopenia, eosinophilia[Ref]

Endocrine

Common (1% to 10%): Hot flushes, galactorrhea
Uncommon (0.1% to 1%): Hypothyroidism
Rare (less than 0.1%): Goiter, gynecomastia, hyperthyroidism
Very rare (less than 0.01%): SIADH (inappropriate antidiuretic hormone secretion syndrome)
Frequency not reported: Increased blood prolactin[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal hepatic function, hepatitis[Ref]

Dermatologic

Very common (10% or more): Increased sweating (up to 29%)
Common (1% to 10%): Rash, pruritus, dermatitis, acne, dry skin, urticaria, abnormal skin odor[Ref]

Other

Very common (10% or more): Fatigue (up to 39%)
Common (1% to 10%): Fever, pain, local edema, chills, otitis media, asthenia, tinnitus, vestibular disorder
Uncommon (0.1% to 1%): Malaise, deafness, earache, foreign body sensation, hyperacusis, parosmia
Rare (less than 0.1%): Dependent edema, labyrinth disorder[Ref]

Metabolic

Very common (10% or more): Weight increase (up to 18%), anorexia (up to 12%), increased appetite (up to 11%)
Common (1% to 10%): Weight decrease, thirst, decreased appetite
Uncommon (0.1%): Dehydration, diabetes mellitus, gout, hypercholesterolemia, hyperglycemia, hyperuricemia, hypokalemia
Rare (less than 0.1%): Fat intolerance, glycosuria[Ref]

Hypersensitivity

Common (1% to 10%): Allergy
Very rare (less than 0.01%): Anaphylactic and anaphylactoid reactions[Ref]

Respiratory

Very common (10% or more): Pharyngitis (up to 14%), rhinitis (up to 12%)
Common (1% to 10%): Yawning, sinusitis, coughing, bronchospasm, epistaxis, dyspnea, laryngitis
Uncommon (0.1% to 1%): Bronchitis, hyperventilation, increased sputum, pneumonia
Rare (less than 1%): Hemoptysis, hypoventilation, laryngismus
Very rare (less than 0.01%): Pneumonitis[Ref]

Ocular

Very common (10% or more): Abnormal vision (up to 18%)
Common (1% to 10%): Abnormal lacrimation, mydriasis, conjunctivitis, anisocoria, blepharospasm, ocular allergy
Uncommon (0.1% to 1%): Abnormal accomodation, diplopia, eye pain, photophobia, scleritis
Rare (less than 0.1%): Blepharitis, chromatopsia, conjunctival hemorrhage, exophthalmos, glaucoma, keratitis, night blindness, retinal disorder, strabismus, visual field defect
Postmarketing reports: Angle-closure glaucoma[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (13%)
Common (1% to 10%): Back pain, arthralgia, muscle weakness
Uncommon (0.1% to 1%): Arthrosis
Rare (less than 0.1%): Dystonia, exostosis, myopathy, myositis, polyarteritis nodosa, torticollis
Frequency nor reported: Rhabdomyolysis[Ref]

Immunologic

Uncommon (0.1% to 1%): Increased susceptibility to infection[Ref]

Renal

Uncommon (0.1% to 1%): Renal calculus, renal pain
Rare (less than 0.1%): Renal cyst[Ref]

References

1. "Product Information. Anafranil (clomipramine)." Basel Pharmaceuticals, Summit, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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.

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