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Anafranil Side Effects

Generic Name: clomipramine

Note: This document contains side effect information about clomipramine. Some of the dosage forms listed on this page may not apply to the brand name Anafranil.

In Summary

Common side effects of Anafranil 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 (the active ingredient contained in Anafranil) 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

General

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

Gastrointestinal

Very common (10% or more): Dry mouth (up to 84%), constipation (up to 47%), nausea (up to 33%), dyspepsia (up to 22%), abdominal pain (up to 13%), diarrhea (up to 13%)

Common (1% to 10%): Abdominal disorders, eructation, esophagitis, flatulence, gastrointestinal disorder, halitosis, tooth disorder, ulcerative stomatitis, vomiting

Uncommon (0.1% to 1%): Blood in stool, colitis, duodenitis, gastric ulcer, gastritis, gastroesophageal reflux, gingivitis, glossitis, hemorrhoids, increased saliva, irritable bowel syndrome, peptic ulcer, rectal hemorrhage, tongue ulceration, tooth caries

Rare (0.01% to 0.1%): Cheilitis, chronic enteritis, discolored feces, gastric dilatation, gingival bleeding

Very rare (less than 0.01%): Paralytic ileus, parotid swelling[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 54%), somnolence (up to 54%), tremor (up to 54%), headache (up to 52%), myoclonus (up to 13%)

Common (1% to 10%): Disturbance in attention, drowsiness, dysgeusia, hypertonia, impaired concentration, memory impairment, migraine, muscle hypertonia, mydriasis, nervousness, paresis, paresthesia, speech disorder, syncope, taste perversion, twitching, vertigo, vestibular disorder

Uncommon (0.1% to 1%): Abnormal coordination, abnormal electroencephalogram (EEG), abnormal gait, ataxia, coma, convulsions, dyskinesia, encephalopathy, extrapyramidal disorder, hyperkinesia, hypokinesia, neuralgia, parosmia, sensory disturbance, stimulation, taste loss

Rare (0.01% to 0.1%): Anticholinergic syndrome, aphasia, apraxia, cerebral hemorrhage, cholinergic syndrome, choreoathetosis, dystonia, generalized spasm, hemiparesis, hyperesthesia, hyperreflexia, hypoesthesia, neuropathy, nystagmus, stupor

Very rare (less than 0.01%): Akathisia, neuroleptic malignant syndrome, peripheral neuropathy, serotonin syndrome, stroke, tardive dyskinesia[Ref]

Genitourinary

Very common (10% or more): Ejaculation failure (up to 42%), impotence (up to 20%), micturition disorder (up to 14%), dysmenorrhea (up to 12%)

Common (1% to 10%): Amenorrhea, breast enlargement, breast pain, dysuria, erectile dysfunction, galactorrhea, leukorrhea, menstrual disorder, micturition frequency, nonpuerperal lactation, urinary retention, urinary tract infection, vaginitis

Uncommon (0.1% to 1%): Endometriosis, epididymitis, genital pruritus, hematuria, nocturia, ovarian cyst, perineal pain, polyuria, prostatic disorder, urethral disorder, urinary incontinence, uterine hemorrhage, vaginal hemorrhage

Rare (0.01% to 0.1%): Albuminuria, breast engorgement, cervical dysplasia, endometrial hyperplasia, intestinal obstruction, oral edema, paralytic ileus, pharyngeal edema, premature ejaculation, pyuria, salivary gland enlargement, uterine inflammation, vaginal bleeding, vulvar disorder

Very rare (less than 0.01%): Testicular swelling

Postmarketing reports: Ejaculation delayed[Ref]

Other

Very common (10% or more): Fatigue (up to 39%)

Common (1% to 10%): Asthenia, chills, fever/hyperpyrexia, otitis media, pain, tinnitus

Uncommon (0.1% to 1%): Cyst, deafness, earache, foreign body sensation, hyperacusis, malaise

Rare (0.01% to 0.1%): Dependent edema, labyrinth disorders

Very rare (less than 0.01%): Sudden death[Ref]

Dermatologic

Very common (10% or more): Increased sweating/hyperhidrosis (up to 29%)

Common (1% to 10%): Abnormal skin odor, allergic dermatitis, acne, dermatitis, dry skin, photosensitivity reaction, pruritus, rash/skin rash, urticaria

Uncommon (0.1% to 1%): Alopecia, cellulitis, eczema, erythematous rash, maculopapular rash, psoriasis, pustular rash, skin discoloration

Rare (0.01% to 0.1%): Chloasma, folliculitis, hypertrichosis, lupus erythematosus rash, piloerection, seborrhea, skin hypertrophy, skin ulceration

Postmarketing reports: Drug rash with eosinophilia and systemic symptom (DRESS)[Ref]

Psychiatric

Hallucinations occurred more frequently in elderly patients and in those with Parkinson's disease.[Ref]

Very common (10% or more): Insomnia (up to 25%), libido change (up to 21%), nervousness (up to 18%)

Common (1% to 10%): Abnormal dreaming, abnormal thinking, aggression, aggressive reaction, agitation, anxiety, confusional state, confusion, delirium, depression/aggravation of depression, depersonalization, disorientation, emotional lability, female orgasmic impotence, hallucinations, irritability, hypomania, libido disorder, mania, nightmares, panic reaction, psychosomatic disorder, restlessness, sleep disorder, withdrawal symptoms, worsening of psychiatric status

Uncommon (0.1% to 1%): Activation of psychotic symptoms, apathy, delusion, euphoria, hostility, hyperagogic hallucinations, manic reaction, paranoia, phobic disorder, psychosis, somnambulism, suicidal ideation, suicide attempt, teeth grinding

Rare (0.01% to 0.1%): Anorgasmy, catalepsy, illusion, impaired impulse control, indecisiveness, mutism, schizophrenic reaction, suicide, withdrawal syndrome

Very rare (less than 0.01%): Suicidal behaviors[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 22%), weight increased (up to 18%), increased appetite (up to 11%)

Common (1% to 10%): Alkaline phosphatase increased, blood sugar changes, decreased appetite, thirst, weight decrease

Uncommon (0.1% to 1%): Dehydration, diabetes mellitus, gout, hypercholesterolemia, hyperglycemia, hyperuricemia, hypokalemia

Rare (0.01% to 0.1%): Fat intolerance[Ref]

Ocular

Very common (10% or more): Abnormal vision (up to 18%)

Common (1% to 10%): Abnormal lacrimation, accommodation disorder, anisocoria, blepharospasm, blurred vision, conjunctivitis, ocular allergy

Uncommon (0.1% to 1%): Abnormal accommodation, diplopia, eye pain, photophobia, scleritis

Rare (0.01% to 0.1%): Oculogyric crisis, oculomotor nerve paralysis

Very rare (less than 0.01%): Blepharitis, chromatopsia, conjunctival hemorrhage, exophthalmos, glaucoma, keratitis, night blindness, retinal disorders, strabismus, visual field defect

Postmarketing reports: Angle-closure glaucoma[Ref]

Respiratory

Very common (10% or more): Pharyngitis (up to 14%), rhinitis (up to 12%)

Common (1% to 10%): Bronchospasm, coughing, dyspnea, epistaxis, laryngitis, sinusitis, yawning

Uncommon (0.1% to 1%): Bronchitis, dysphonia, hyperventilation, increased sputum, pneumonia

Rare (0.01% to 0.1%): Hemoptysis, hiccup, hypoventilation, laryngismus

Very rare (less than 0.01%): Alveolitis allergic (pneumonitis) with/without eosinophilia[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 13%)

Common (1% to 10%): Arthralgia, back pain, muscle weakness

Uncommon (0.1% to 1%): Arthrosis, leg cramps

Rare (0.01% to 0.1%): Bruising, exostosis, myopathy, myositis, polyarteritis nodosa, torticollis

Frequency not reported: Bone fractures, rhabdomyolysis[Ref]

Cardiovascular

Common (1% to 10%): Chest pain, clinically irrelevant ECG changes (e.g., T- and ST- wave changes in patients of normal cardiac status), flushing, hot flushes, local edema, orthostatic hypotension, palpitation, postural hypotension, sinus tachycardia, tachycardia

Uncommon (0.1% to 1%): Abnormal ECG, arrhythmia, blood pressure increased, bradycardia, cardiac arrest, extrasystoles, general edema, pallor

Rare (0.01% to 0.1%): Aneurysm, atrial flutter, bundle branch block, cardiac failure, cyanosis, heart block, myocardial infarction, myocardial ischemia, peripheral ischemia, thrombophlebitis, vasospasm, ventricular tachycardia

Very rare (less than 0.01%): Cardiomyopathy, conduction disorder, congestive cardiac failure, edema, hypotension, prolonged PR and QTc (QT/RR) intervals, Torsade de pointes, widening of QRS complex[Ref]

Hematologic

Common (1% to 10%): Anemia, purpura

Uncommon (0.1% to 1%): Lymphadenopathy

Rare (0.01% to 0.1%): Leukemoid reaction, lymphoma-like disorder, marrow depression

Very rare (less than 0.01%): Agranulocytosis, eosinophilia, leukopenia, thrombocytopenia

Frequency not reported: Pancytopenia[Ref]

Renal

Common (1% to 10%): Cystitis

Uncommon (0.1% to 1%): Oliguria, renal calculus, renal pain

Rare (0.01% to 0.1%): Glycosuria, pyelonephritis, renal cyst[Ref]

Hepatic

Common (1% to 10%): Transaminases increased

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

Very rare (less than 0.01%): Acute hepatitis, hepatic necrosis, hepatitis with/without jaundice[Ref]

Hypersensitivity

Common (1% to 10%): Allergy

Very rare (less than 0.01%): Anaphylactic reaction, anaphylactoid reaction[Ref]

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism

Rare (0.01% to 0.1%): Goiter, gynecomastia, hyperthyroidism

Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone (SIADH) secretion

Frequency not reported: Blood prolactin increased[Ref]

Immunologic

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

Oncologic

Rare (0.01% to 0.1%): Breast fibroadenosis[Ref]

References

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

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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