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.

Some side effects of Anafranil 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, 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
  • congestion
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cough
  • difficult, burning, or painful urination
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dryness or soreness of the throat
  • excessive muscle tone
  • fear or nervousness
  • feeling sad or empty
  • fever
  • frequent urge to urinate
  • hearing loss
  • hoarseness
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • muscle stiffness
  • muscle tension or tightness
  • muscle twitching or jerking
  • pain or tenderness around the eyes and cheekbones
  • poor concentration
  • problems in urination or increase in the amount of urine
  • rhythmic movement of muscles
  • runny nose
  • shortness of breath or troubled breathing
  • sneezing
  • stuffy nose
  • sweating
  • tender, swollen glands in the neck
  • tightness of the chest or wheezing
  • tiredness
  • trouble concentrating
  • trouble remembering
  • trouble sleeping
  • trouble swallowing
  • unusual tiredness or weakness
  • voice changes
Less common
  • Anger that is hard to control
  • anxiety
  • bloody nose
  • breast enlargement
  • burning, dry, or itching eyes
  • burning while urinating
  • changes in vision
  • chills
  • crying
  • decrease in the frequency of urination
  • decrease in urine volume
  • depersonalization
  • difficulty in passing urine (dribbling)
  • difficulty in speaking
  • discharge or excessive tearing
  • dry mouth
  • dysphoria
  • earache
  • euphoria
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of unreality
  • headache, severe and throbbing
  • hyperventilation
  • increased clear or white vaginal discharge
  • increased watering of the mouth
  • irregular heartbeats
  • irritability
  • itching of the vagina or genital area
  • mental depression
  • nausea or vomiting
  • numbness, tingling, pain, or weakness in the hands or feet
  • pain during sexual intercourse
  • pale skin
  • panic attacks
  • paranoia
  • partial or slight paralysis
  • quick to react or overreact emotionally
  • rapidly changing moods
  • redness or swelling in the ear
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • restlessness
  • sense of detachment from self or body
  • shaking
  • swelling of the face, fingers, feet, or lower legs
  • thick, white vaginal discharge with no odor or with a mild odor
  • troubled breathing with exertion
  • unusual bleeding or bruising

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
  • Acid or sour stomach
  • bad, unusual, or unpleasant aftertaste
  • belching
  • blemishes on the skin
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloated
  • change in taste
  • change or problem with discharge of semen
  • changes in vision
  • constipation
  • cracked, dry, or scaly skin
  • cramps
  • darkening or lightening of skin color
  • decreased interest in sexual intercourse
  • diarrhea
  • difficulty with moving
  • dry skin
  • excess air or gas in the stomach or intestines
  • feeling of warmth
  • full feeling
  • heartburn
  • heavy bleeding
  • hives or welts
  • inability to have or keep an erection
  • increased appetite
  • increased in sexual ability, desire, drive, or performance
  • increased interest in sexual intercourse
  • indigestion
  • joint pain
  • loss in sexual ability, desire, drive, or performance
  • pain
  • passing gas
  • pimples
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • shakiness in the legs, arms, hands, or feet
  • skin rash
  • 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
  • increased yawning
  • pinpoint red or purple spots on the skin
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • stopping of menstrual bleeding

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 (the active ingredient contained in Anafranil) 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 (the active ingredient contained in Anafranil)

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 (the active ingredient contained in Anafranil) 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 (the active ingredient contained in Anafranil) 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 (the active ingredient contained in Anafranil) (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 (the active ingredient contained in Anafranil) 150 mg daily. A case of clomipramine-induced diabetes has also been reported.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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