Celexa Side Effects

Generic Name: citalopram

Please note - some side effects for Celexa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Celexa - for the Consumer

Celexa

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Celexa:

Decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased sweating; lightheadedness when you stand or sit up; loss of appetite; nausea; stuffy nose; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); absent menstrual period; bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; fainting; fast or irregular heartbeat; hallucinations; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; severe or persistent headache; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vision changes; worsening of depression.

Celexa Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Celexa Solution:

Decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased sweating; lightheadedness when you stand or sit up; loss of appetite; nausea; stuffy nose; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); absent menstrual period; bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; fainting; fast or irregular heartbeat; hallucinations; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; severe or persistent headache; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vision changes; worsening of depression.

Celexa Side Effects - for the Professional

Celexa

The premarketing development program for Celexa included citalopram exposures in patients and/or normal subjects from 3 different groups of studies: 429 normal subjects in clinical pharmacology/pharmacokinetic studies; 4422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1370 patient-exposure years. There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with Celexa varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials

Among 1063 depressed patients who received Celexa at doses ranging from 10 to 80 mg/day in placebo-controlled trials of up to 6 weeks in duration, 16% discontinued treatment due to an adverse event, as compared to 8% of 446 patients receiving placebo. The adverse events associated with discontinuation and considered drug-related (i.e., associated with discontinuation in at least 1% of Celexa-treated patients at a rate at least twice that of placebo) are shown in TABLE 2. It should be noted that one patient can report more than one reason for discontinuation and be counted more than once in this table.

Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred among 1063 depressed patients who received Celexa at doses ranging from 10 to 80 mg/day in placebo-controlled trials of up to 6 weeks in duration. Events included are those occurring in 2% or more of patients treated with Celexa and for which the incidence in patients treated with Celexa was greater than the incidence in placebo-treated patients.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

The only commonly observed adverse event that occurred in Celexa patients with an incidence of 5% or greater and at least twice the incidence in placebo patients was ejaculation disorder (primarily ejaculatory delay) in male patients.

The potential relationship between the dose of Celexa administered and the incidence of adverse events was examined in a fixed-dose study in depressed patients receiving placebo or Celexa 10, 20, 40, and 60 mg. Jonckheere's trend test revealed a positive dose response (p<0.05) for the following adverse events: fatigue, impotence, insomnia, sweating increased, somnolence, and yawning.

Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that SSRIs can cause such untoward sexual experiences.

Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence.

The table below displays the incidence of sexual side effects reported by at least 2% of patients taking Celexa in a pool of placebo-controlled clinical trials in patients with depression.

In female depressed patients receiving Celexa, the reported incidence of decreased libido and anorgasmia was 1.3% (n=638 females) and 1.1% (n=252 females), respectively.

There are no adequately designed studies examining sexual dysfunction with citalopram treatment.

Priapism has been reported with all SSRIs.

While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.

Celexa and placebo groups were compared with respect to (1) mean change from baseline in vital signs (pulse, systolic blood pressure, and diastolic blood pressure) and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses did not reveal any clinically important changes in vital signs associated with Celexa treatment. In addition, a comparison of supine and standing vital sign measures for Celexa and placebo treatments indicated that Celexa treatment is not associated with orthostatic changes.

Patients treated with Celexa in controlled trials experienced a weight loss of about 0.5 kg compared to no change for placebo patients.

Celexa and placebo groups were compared with respect to (1) mean change from baseline in various serum chemistry, hematology, and urinalysis variables, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed no clinically important changes in laboratory test parameters associated with Celexa treatment.

Electrocardiograms from Celexa (N=802) and placebo (N=241) groups were compared with respect to (1) mean change from baseline in various ECG parameters, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. The only statistically significant drug-placebo difference observed was a decrease in heart rate for Celexa of 1.7 bpm compared to no change in heart rate for placebo. There were no observed differences in QT or other ECG intervals.

Other Events Observed During the Premarketing Evaluation of Celexa (citalopram HBr)

Following is a list of WHO terms that reflect treatment-emergent adverse events, as defined in the introduction to the ADVERSE REACTIONS section, reported by patients treated with Celexa at multiple doses in a range of 10 to 80 mg/day during any phase of a trial within the premarketing database of 4422 patients. All reported events are included except those already listed in Table 3 or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and those occurring in only one patient. It is important to emphasize that, although the events reported occurred during treatment with Celexa, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in less than 1/100 patients but at least 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Cardiovascular - Frequent: tachycardia, postural hypotension, hypotension. Infrequent: hypertension, bradycardia, edema (extremities), angina pectoris, extrasystoles, cardiac failure, flushing, myocardial infarction, cerebrovascular accident, myocardial ischemia. Rare: transient ischemic attack, phlebitis, atrial fibrillation, cardiac arrest, bundle branch block.

Central and Peripheral Nervous System Disorders - Frequent: paresthesia, migraine. Infrequent: hyperkinesia, vertigo, hypertonia, extrapyramidal disorder, leg cramps, involuntary muscle contractions, hypokinesia, neuralgia, dystonia, abnormal gait, hypesthesia, ataxia. Rare: abnormal coordination, hyperesthesia, ptosis, stupor.

Endocrine Disorders - Rare: hypothyroidism, goiter, gynecomastia.

Gastrointestinal Disorders - Frequent: saliva increased, flatulence. Infrequent: gastritis, gastroenteritis, stomatitis, eructation, hemorrhoids, dysphagia, teeth grinding, gingivitis, esophagitis. Rare: colitis, gastric ulcer, cholecystitis, cholelithiasis, duodenal ulcer, gastroesophageal reflux, glossitis, jaundice, diverticulitis, rectal hemorrhage, hiccups.

General - Infrequent: hot flushes, rigors, alcohol intolerance, syncope, influenza-like symptoms. Rare: hayfever.

Hemic and Lymphatic Disorders - Infrequent: purpura, anemia, epistaxis, leukocytosis, leucopenia, lymphadenopathy. Rare: pulmonary embolism, granulocytopenia, lymphocytosis, lymphopenia, hypochromic anemia, coagulation disorder, gingival bleeding.

Metabolic and Nutritional Disorders - Frequent: decreased weight, increased weight. Infrequent: increased hepatic enzymes, thirst, dry eyes, increased alkaline phosphatase, abnormal glucose tolerance. Rare: bilirubinemia, hypokalemia, obesity, hypoglycemia, hepatitis, dehydration.

Musculoskeletal System Disorders - Infrequent: arthritis, muscle weakness, skeletal pain. Rare: bursitis, osteoporosis.

Psychiatric Disorders - Frequent: impaired concentration, amnesia, apathy, depression, increased appetite, aggravated depression, suicide attempt, confusion. Infrequent: increased libido, aggressive reaction, paroniria, drug dependence, depersonalization, hallucination, euphoria, psychotic depression, delusion, paranoid reaction, emotional lability, panic reaction, psychosis. Rare: catatonic reaction, melancholia.

Reproductive Disorders/Female* - Frequent: amenorrhea. Infrequent: galactorrhea, breast pain, breast enlargement, vaginal hemorrhage.

*% based on female subjects only: 2955

Respiratory System Disorders - Frequent: coughing. Infrequent: bronchitis, dyspnea, pneumonia. Rare: asthma, laryngitis, bronchospasm, pneumonitis, sputum increased.

Skin and Appendages Disorders - Frequent: rash, pruritus. Infrequent: photosensitivity reaction, urticaria, acne, skin discoloration, eczema, alopecia, dermatitis, skin dry, psoriasis. Rare: hypertrichosis, decreased sweating, melanosis, keratitis, cellulitis, pruritus ani.

Special Senses - Frequent: accommodation abnormal, taste perversion. Infrequent: tinnitus, conjunctivitis, eye pain. Rare: mydriasis, photophobia, diplopia, abnormal lacrimation, cataract, taste loss.

Urinary System Disorders - Frequent: polyuria. Infrequent: micturition frequency, urinary incontinence, urinary retention, dysuria. Rare: facial edema, hematuria, oliguria, pyelonephritis, renal calculus, renal pain.

Other Events Observed During the Postmarketing Evaluation of Celexa (citalopram HBr)

It is estimated that over 30 million patients have been treated with Celexa since market introduction. Although no causal relationship to Celexa treatment has been found, the following adverse events have been reported to be temporally associated with Celexa treatment, and have not been described elsewhere in labeling: acute renal failure, akathisia, allergic reaction, anaphylaxis, angioedema, choreoathetosis, chest pain, delirium, dyskinesia, ecchymosis, epidermal necrolysis, erythema multiforme, gastrointestinal hemorrhage, glaucoma, grand mal convulsions, hemolytic anemia, hepatic necrosis, myoclonus, nystagmus, pancreatitis, priapism, prolactinemia, prothrombin decreased, QT prolonged, rhabdomyolysis, spontaneous abortion, thrombocytopenia, thrombosis, ventricular arrhythmia, torsade de pointes, and withdrawal syndrome.

Side Effects by Body System

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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