Citalopram Side Effects

Some side effects of citalopram 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 citalopram: oral solution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking citalopram: skin rash or hives; difficulty 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:

• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• agitation, hallucinations, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, feeling like you might pass out;

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats; or

• headache, slurred speech, severe weakness, muscle cramps, feeling unsteady, seizure (convulsions), shallow breathing (breathing may stop).

Common side effects may include:

• drowsiness, tired feeling;

• sleep problems (insomnia);

• mild nausea, diarrhea, upset stomach, dry mouth;

• cold symptoms such as stuffy nose, sneezing, sore throat, cough;

• increased sweating or urination, weight 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 citalopram: oral solution, oral tablet

Nervous system

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.

Nervous system side effects including headache (26%), dry mouth (20%), increased sweating (11%), tremor (8%), dizziness (2%), and sleep abnormalities have been reported. Paresthesia, and migraine have been reported frequently. Hyperkinesia, vertigo, hypertonia, extrapyramidal disorder, leg cramps, involuntary muscle contractions, hypokinesia, neuralgia, dystonia, abnormal gait, hypesthesia and ataxia have been reported infrequently. Neuroleptic malignant syndrome, serotonin syndrome, abnormal coordination, hyperesthesia, ptosis, stupor, and choreoathetosis have rarely been reported. Akathisia, dyskinesia, and grand mal convulsions have been reported to be temporally associated with citalopram treatment.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 21%), diarrhea (8%), and dyspepsia (5%) have been reported. Increased saliva and flatulence have been reported frequently. Gastritis, gastroenteritis, stomatitis, eructation, hemorrhoids, dysphagia, teeth grinding, gingivitis, and esophagitis have been reported infrequently. Colitis, gastric ulcer, cholecystitis, cholelithiasis, duodenal ulcer, gastroesophageal reflux, glossitis, jaundice, diverticulosis, rectal hemorrhage, pancreatitis, and hiccups have rarely been reported. Gastrointestinal hemorrhage has been reported to be temporally associated with the use of citalopram.

A study of 26,005 antidepressant users has reported 3.6 times more upper GI bleeding episodes with the use of SSRIs relative to the population who did not receive antidepressant medications. Upper gastrointestinal tract bleeding was observed in 4.1 times more frequently in patients receiving citalopram.

Psychiatric

Psychiatric side effects including somnolence (18%), insomnia (up to 15%), anxiety (4%), anorexia (4%), agitation (3%), dysmenorrhea (3%), decreased libido (2%), and yawning (2%) have been reported. Impaired concentration, amnesia, apathy, depression, increased appetite, aggravated depression, suicide attempt, and confusion have been reported frequently. Increased libido, aggressive reaction, paranoia, drug dependence, depersonalization, hallucination, euphoria, psychotic depression, delusion, paranoid reaction, emotional lability, panic reaction, and psychosis have been reported infrequently. Catatonic reaction, withdrawal syndrome and melancholia have been reported rarely. Delirium has been reported to be temporally associated with citalopram treatment.

Genitourinary

Genitourinary side effects including ejaculatory disorder (primarily ejaculatory delay) (6%), and impotence (3%) have been reported. Amenorrhea has been reported frequently. Female reproductive disorders including galactorrhea, breast pain, breast enlargement, and vaginal hemorrhage have been reported infrequently. Priapism has been reported rarely. A case of spontaneous ejaculation has also been reported.

Respiratory

Respiratory system side effects including upper respiratory tract infection (5%), rhinitis (5%), and sinusitis (3%) have been reported. Coughing has been reported frequently. Bronchitis, dyspnea, and pneumonia have been reported infrequently. Asthma, laryngitis, bronchospasm, pneumonitis and increased sputum have been reported rarely.

Other

Withdrawal effects are generally self-limiting. However, there have been reports of serious discontinuation symptoms. Patients should be monitored for withdrawal symptoms when discontinuing treatment with citalopram. Gradual reduction of the dose is recommended whenever possible. If intolerable symptoms occur due to a decrease in dosage or discontinuation of treatment, then resuming the previously prescribed dose may be appropriate. This may be followed by a more gradual reduction in dosage.

Other side effects occurring upon discontinuation of citalopram have been reported, particularly when the discontinuation has been abrupt. These withdrawal effects have included dysphoric mood, irritability, agitation, dizziness, sensory disturbances including unfavorable smell, anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania.

General

General side effects including fatigue (5% to 6%), fever (2%), and asthenia (1%) have been reported. Hot flushes, rigors, alcohol intolerance, syncope, and influenza-like symptoms have been reported infrequently. Hay fever has been reported rarely. Chest pain has been reported to be temporally associated with the use of citalopram. Serotonin syndrome has been reported in two patients who were concomitantly receiving linezolid (a reversible nonselective MAOI).

Musculoskeletal

While not reported for citalopram, in one study using the healthcare data from the province of Ontario, Canada reviewing 8,239 patients treated for hip fractures, the adjusted odds ratio for hip fracture was 2.4 for exposure to selective serotonin reuptake inhibitors (including fluoxetine, fluvoxamine, paroxetine, and sertraline), compared to participants who had no exposure to antidepressants. A similar odds ratio for hip fracture may be present for patients using citalopram.

Musculoskeletal system side effects including arthralgia (2%), and myalgia (2%) have been reported. Arthritis, muscle weakness, and skeletal pain have been reported infrequently. Bursitis and osteoporosis have rarely been reported. Rhabdomyolysis has been reported to be temporally associated with citalopram treatment.

Cardiovascular

Cardiovascular side effects including tachycardia, postural hypotension, and hypotension have been reported frequently. Hypertension, bradycardia, edema (extremities), angina pectoris, extrasystoles, cardiac failure, flushing, myocardial infarction, cerebrovascular accident, and myocardial ischemia have been reported infrequently. Transient ischemic attack, phlebitis, atrial fibrillation, cardiac arrest, bundle branch block, thrombocytopenia, ventricular arrhythmia, Torsades de pointes, and angioedema have rarely been reported. Prolonged QT interval has been reported to be temporally associated with citalopram treatment.

Endocrine

Endocrine side effects including hypothyroidism, goiter, and gynecomastia have rarely been reported. Several cases of the syndrome of inappropriate secretion of antidiuretic hormone have been reported. Three cases of hyponatremia secondary to the syndrome of inappropriate secretion of antidiuretic hormone have also been reported. Prolactinemia has been reported to be temporally associated with citalopram treatment.

Hematologic

Two studies have reported that concurrent use of a nonsteroidal anti-inflammatory drug or aspirin potentiated the risk of bleeding. These studies focused on upper gastrointestinal bleeding. However, the manufacturer has reported that there is reason to believe that bleeding at other sites may be similarly potentiated. Patients should be warned about the risk of bleeding from concurrent use of citalopram and NSAIDS, aspirin, or other drugs that affect coagulation.

Hematologic side effects including purpura, anemia, epistaxis, leukocytosis, leukopenia, and lymphadenopathy have been reported infrequently. Pulmonary embolism, granulocytopenia, lymphocytosis, lymphopenia, hypochromic anemia, coagulation disorder, and gingival bleeding have rarely been reported. Decreased prothrombin, hemolytic anemia, and thrombosis have been reported to be temporally associated with citalopram treatment.

Bleeding episodes have been reported in patients treated with psychotropic drugs that interfere with serotonin reuptake. Subsequent epidemiological studies have reported an association between the use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding.

Metabolic

The results of one study appear to indicate that treatment with selective serotonin reuptake inhibitors (i.e., paroxetine, sertraline, citalopram) may cause an increase in serum total cholesterol, HDL cholesterol, and/or LDL cholesterol. However, additional studies are necessary to confirm these findings.

Numerous cases of hyponatremia have been reported following treatment with a selective serotonin reuptake inhibitor (SSRI). Risk factors for the development of SSRI-associated hyponatremia including advanced age, female gender, concomitant use of diuretics, low body weight, and lower baseline serum sodium levels have been identified. Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment. The proposed mechanism for the development of hyponatremia involves the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) via release of antidiuretic hormone.

Metabolic and nutritional side effects including weight increase or decrease have been reported frequently. Increased hepatic enzymes, thirst, dry eyes, increased alkaline phosphatase, and abnormal glucose tolerance have been reported infrequently. Bilirubinemia, hypokalemia, hyponatremia, obesity, hypoglycemia, hepatitis, and dehydration have rarely been reported. An increase in serum cholesterol has been reported following use of citalopram.

Dermatologic

Dermatologic side effects including rash and pruritus have been reported frequently. Photosensitivity reaction, urticaria, acne, skin discoloration, eczema, alopecia, dermatitis, dry skin, and psoriasis have been reported infrequently. Hypertrichosis, decreased sweating, melanosis, keratitis, cellulitis, and pruritus ani have rarely been reported. Ecchymosis has been reported to be temporally associated with the use of citalopram. One case of escitalopram-induced cutaneous leukocytoclastic vasculitis has been reported.

One case of cutaneous leukocytoclastic vasculitis has been reported in a patient receiving escitalopram (dose not stated). The lesions disappeared one week following discontinuation of escitalopram and reappeared upon rechallenge. A similar reaction occurred when the patient was switched to paroxetine.

Ocular

The ocular side effect of abnormal accommodation has been reported frequently. Conjunctivitis, and eye pain have been reported infrequently. Mydriasis, photophobia, diplopia, abnormal lacrimation and cataract have been reported infrequently. Epidermal necrolysis and erythema multiforme have been reported rarely. Nystagmus has been reported to be temporally associated with citalopram treatment.

Other

Several side effects on senses have been reported. Taste perversion has been reported frequently. Tinnitus has been reported infrequently. Taste loss has rarely been reported.

Hepatic

Hepatic side effects including necrosis have been reported rarely.

Renal

Renal side effects including acute renal failure have been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis and allergic reaction have been reported.

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