CELEXA SIDE EFFECTS

More common side effects may include:
Abdominal pain, agitation, anxiety, diarrhea, drowsiness, dry mouth, ejaculation disorders, fatigue, impotence, indigestion, insomnia, loss of appetite, nausea, painful menstruation, respiratory tract infection, sinus or nasal inflammation, sweating, tremor, vomiting

Less common side effects may include:
Amnesia, attempted suicide, confusion, coughing, decreased sexual drive, depression, excessive urination, fever, gas, impaired concentration, increased appetite, increased salivation, itching, joint pain, lack of emotion, loss of menstruation, low blood pressure, migraine, muscle pain, rapid heartbeat, rash, skin tingling, taste disturbances, visual disturbances, weight gain, weight loss, yawning

Rare side effects may include:
Abnormal dreams, acne, aggressive behavior, alcohol intolerance, angina (chest pain), arthritis, belching, bone pain, breast enlargement, breast pain, bronchitis, bruising, chills, conjunctivitis (pinkeye), decreased muscle movements, delusions, dermatitis, difficulty breathing, difficulty swallowing, dizziness, drug dependence, dry eyes, dry skin, eczema, emotional instability, excessive milk flow, excessive muscle tone, eye pain, fainting, feeling of well-being, flu-like symptoms, flushing, frequent urination, gum inflammation, hair loss, hallucinations, heart attack, heart failure, hemorrhoids, high blood pressure, hives, hot flashes, inability to hold urine, inability to urinate completely, increased sex drive, increased urination, involuntary muscle movements, leg cramps, mouth sores, muscle weakness, nosebleeds, numbness, painful erection, painful urination, panic, paranoia, pneumonia, psoriasis, psychosis, ringing in the ears, sensitivity to light, skin discoloration, slow heartbeat, stomach and intestinal inflammation, stroke, swelling, teeth grinding, thirst, uncontrollable muscle movements, unsteady or abnormal walk, vaginal bleeding
Why should this drug not be prescribed?
If Celexa gives you an allergic reaction, you cannot continue using it. Also remember that Celexa must never be combined with an MAO inhibitor .

 

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 treatmentemergent 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 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 1. It should be noted that one patient can report more than one reason for discontinuation and be counted more than once in this table.

 

Adverse Events Occurring at an Incidence of 2% or More Among Celexa –Treated Patients

 

Table 2 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 (see TABLE 2).

*Events reported by at least 2% of patients treated with Celexa are reported, except for the following events which had an incidence on placebo ³ Celexa: headache, asthenia, dizziness, constipation, palpitation, vision abnormal, sleep disorder, nervousness, pharyngitis, micturition disorder, back pain.

 

Dose Dependency of Adverse Events

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.

 

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 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.

 

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