DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Citalopram (Citalopram Hydrobromide) - Side Effects and Adverse Reactions



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

Adverse Events Associated with Discontinuation of Treatment

Among 1063 depressed patients who received citalopram tablets 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 citalopram tablets-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 2 Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled, Depression Trials
Body System/Adverse EventPercentage of Patients Discontinuing Due to Adverse Event Citalopram (N=1063)Placebo (N=446)GeneralAsthenia1%<1%Gastrointestinal DisordersNausea4%0%Dry Mouth1%<1%Vomiting1%0%Central and Peripheral Nervous System DisordersDizziness2%<1%Psychiatric DisordersInsomnia3%1%Somnolence2%1%Agitation1%<1%
Adverse Events Occurring at an Incidence of 2% or More Among Citalopram-Treated Patients

Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred among 1063 depressed patients who received citalopram tablets 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 citalopram tablets and for which the incidence in patients treated with citalopram tablets were 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 citalopram 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 (see TABLE 3).
TABLE 3 Treatment-Emergent Adverse Events: Incidence in Placebo-Controlled Clinical Trials*
Body System/Adverse Event(Percentage of Patients Reporting Event) Citalopram Tablets (N=1063)Placebo (N=446)* Events reported by at least 2% of patients treated with citalopram tablets are reported, except for the following events which had an incidence on placeboAutonomic Nervous System DisordersDry Mouth20%14%Sweating Increased11%9%Central & Peripheral Nervous System DisordersTremor8%6%Gastrointestinal DisordersNausea21%14%Diarrhea8%5%Dyspepsia5%4%Vomiting4%3%Abdominal Pain3%2%GeneralFatigue5%3%Fever2%<1%Musculoskeletal System DisordersArthralgia2%1%Myalgia2%1%Psychiatric DisorderSomnolence18%10%Insomnia15%14%Anxiety4%3%Anorexia4%2%Agitation3%1%Dysmenorrhea13%2%Libido Decreased2%<1%Yawning2%<1%Respiratory System DisordersUpper Respiratory Tract Infection5%4%Rhinitis5%3%Sinusitis3%<1%UrogenitalEjaculation Disorder2,36%1%Impotence33%<1%
Dose Dependency of Adverse Events

The potential relationship between the dose of citalopram tablets administered and the incidence of adverse events was examined in a fixed-dose study in depressed patients receiving placebo or citalopram tablets 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.
Male and Female Sexual Dysfunction with SSRIs

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 citalopram tablets in a pool of placebo-controlled clinical trials in patients with depression.
TreatmentCitalopram Tablets (425 males)Placebo (194 males)Abnormal Ejaculation (mostly ejaculatory delay)6.1% (males only)1% (males only)Libido Decreased3.8% (males only)<1% (males only)Impotence2.8% (males only)<1% (males only)
In female depressed patients receiving citalopram tablets, 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.
Vital Sign Changes

Citalopram tablets 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 citalopram hydrobromide treatment. In addition, a comparison of supine and standing vital sign measures for citalopram tablets and placebo treatments indicated that citalopram tablets treatment is not associated with orthostatic changes.
Weight Changes

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

Citalopram tablets 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 citalopram tablets treatment.
ECG Changes

Electrocardiograms from citalopram tablets (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 citalopram tablets 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 Citalopram Tablets

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 citalopram tablets 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 citalopram tablets, they were not necessarily caused by it.

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 Citalopram Tablets

It is estimated that over 30 million patients have been treated with citalopram since market introduction. Although no causal relationship to citalopram treatment has been found, the following adverse events have been reported to be temporally associated with citalopram 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.


Below is a sample of reports where side effects / adverse reactions may be related to Citalopram. The information is not vetted and should not be considered as verified clinical evidence.

Possible Citalopram side effects / adverse reactions in 28 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-03

Patient: 28 year old female

Reactions: Intentional Overdose, Major Depression, Loss of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Possible Citalopram side effects / adverse reactions in 61 year old male

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-10-10

Patient: 61 year old male

Reactions: Haemoglobin Decreased, C-Reactive Protein Increased, Cardiotoxicity, Electrocardiogram ST Segment Elevation, White Blood Cell Count Increased, Sinus Bradycardia

Adverse event resulted in: hospitalization

Suspect drug(s):
Oxycodone HCL
    Indication: Back Pain

    Indication: Rectal Cancer

    Indication: Depression

    Indication: Dyslipidaemia

Possible Citalopram side effects / adverse reactions in 45 year old female

Reported by a individual with unspecified qualification from Brazil on 2011-10-10

Patient: 45 year old female weighing 82.0 kg (180.4 pounds)

Reactions: Myocardial Infarction, Transient Ischaemic Attack, Erysipelas

Suspect drug(s):
    Dosage: 200 mg, unk

    Dosage: 20 mg, unk

    Dosage: 20 mg, unk

    Dosage: 160 mg vals and 5 mg amlo
    Indication: Hypertension

Galvus MET
    Dosage: 500 mg metf and 50 mg vild

Metoprolol Succinate
    Dosage: 100 mg, unk

    Dosage: 50 mg/day

    Dosage: 200 mg/day

    Dosage: 320 mg vals and 5 mg amlo

Other drugs received by patient: Rosuvastatin

See index of all Citalopram side effect reports >>

Drug label data at the top of this Page last updated: 2011-08-08

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017