Anafranil 75 mg

20 tablets

Anafranil Side Effects

Generic name: clomipramine
Applies to clomipramine: oral capsule.

Warning

Oral route (Capsule)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. These risks must be balanced with clinical need. Families and caregivers should closely observe the patient and stay in close contact with the prescriber. This drug is not approved for use in pediatric patients except for those with obsessive compulsive disorder (OCD).

Serious side effects of Anafranil

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
• hives or welts, skin rash
• 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
• anxiety
• breast enlargement
• changes in vision
• chest pain or discomfort
• chills
• decrease in the frequency of urination
• deep or fast breathing with dizziness
• difficulty in speaking
• dry mouth
• fast, irregular, pounding, or racing heartbeat or pulse
• headache, severe and throbbing
• nausea
• numbness of the feet, hands, and around the mouth
• numbness, tingling, pain, or weakness in the hands or feet
• pain during sexual intercourse
• paranoia
• rapidly changing moods
• restlessness
• shaking
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• sweating
• swelling of the face, fingers, feet, or lower legs
• vomiting

Incidence not known

• Agitation
• blindness
• cough
• decreased awareness or responsiveness
• depression
• dizziness
• eye pain
• hostility
• increased thirst
• loss of consciousness
• muscle pain, cramps, or twitching
• rapid weight gain
• seizures
• severe sleepiness
• sore throat
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tearing
• unusual drowsiness, dullness, or feeling of sluggishness
• yellow skin or eyes

Other side effects of Anafranil

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 bothersomeor 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
• inability to have or keep an erection
• increased interest in sexual intercourse
• joint pain or swelling
• 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
• trembling or shaking of the hands or feet

Less common

• Absent, missed, or irregular menstrual periods
• breast pain

For Healthcare Professionals

Applies to clomipramine: oral capsule.

General

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

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

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

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

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

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) 

Psychiatric

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

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

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

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

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

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

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

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

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

Hypersensitivity

Common (1% to 10%): Allergy
Very rare (less than 0.01%): Anaphylactic reaction, anaphylactoid reaction

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

Immunologic

Uncommon (0.1% to 1%): Increased susceptibility to infection

Oncologic

Rare (0.01% to 0.1%): Breast fibroadenosis