ADVERSE REACTIONS
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
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.
TABLE 1
Adverse Events Associated with Discontinuation
of Treatment in Short-Term, Placebo-Controlled, Depression Trials
| Body System/Adverse Event |
Percentage of Patients Discontinuing Due to Adverse Event |
| Citalopram (N=1063) |
Placebo (N=446) |
| |
|
| General |
|
Asthenia
|
1%
|
<1%
|
| Gastrointestinal Disorders |
|
Nausea
|
4%
|
0%
|
|
Dry Mouth
|
1%
|
<1%
|
|
Vomiting
|
1%
|
0%
|
| Central and Peripheral Nervous System Disorders |
|
Dizziness
|
2%
|
<1%
|
| Psychiatric Disorders |
|
Insomnia
|
3%
|
1%
|
|
Somnolence
|
2%
|
1%
|
|
Agitation
|
1%
|
<1%
|
|
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).
TABLE 2
Treatment-Emergent Adverse Events: Incidence in Placebo-Controlled Clinical Trials *
| Body System/Adverse Event |
(Percentage of Patients Reporting Event) |
Celexa
(N=1063) |
Placebo
(N=446) |
| Autonomic Nervous System Disorders |
|
Dry Mouth
|
20%
|
14%
|
|
Sweating Increased
|
11%
|
9%
|
| Central & Peripheral Nervous System Disorders |
|
Tremor
|
8%
|
6%
|
| Gastrointestinal Disorders |
|
Nausea
|
21%
|
14%
|
|
Diarrhea
|
8%
|
5%
|
|
Dyspepsia
|
5%
|
4%
|
|
Vomiting
|
4%
|
3%
|
|
Abdominal Pain
|
3%
|
2%
|
| General |
|
Fatigue
|
5%
|
3%
|
|
Fever
|
2%
|
<1%
|
| Musculoskeletal System Disorders |
|
Arthralgia
|
2%
|
1%
|
|
Myalgia
|
2%
|
1%
|
| Psychiatric Disorders |
|
Somnolence
|
18%
|
10%
|
|
Insomnia
|
15%
|
14%
|
|
Anxiety
|
4%
|
3%
|
|
Anorexia
|
4%
|
2%
|
|
Agitation
|
3%
|
1%
|
|
Dysmenorrhea 1 |
3%
|
2%
|
|
Libido Decreased
|
2%
|
<1%
|
|
Yawning
|
2%
|
<1%
|
| Respiratory System Disorders |
Upper Respiratory Tract
Infection
|
5%
|
4%
|
|
Rhinitis
|
5%
|
3%
|
|
Sinusitis
|
3%
|
<1%
|
| Urogenital |
|
Ejaculation Disorder 2,
3 |
6%
|
1%
|
|
Impotence3 |
3%
|
<1%
|
|
*Events reported by at least 2% of patients treated with Celexa are reported, except for the following events which had an incidence on placebo >/= Celexa: headache, asthenia, dizziness, constipation, palpitation, vision abnormal, sleep disorder, nervousness, pharyngitis, micturition disorder, back pain.
|
| 1 Denominator used was for females only (N=638 Celexa; N=252 placebo).
|
| 2 Primarily ejaculatory delay.
|
| 3 Denominator used was for males only (N=425 Celexa; N=194 placebo).
|
|
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.
|
Treatment
|
Celexa
(425 males) |
Placebo
(194 males) |
Abnormal Ejaculation
(mostly ejaculatory delay)
|
6.1%
(males only) |
1%
(males only) |
|
Libido Decreased
|
3.8%
(males only) |
<1%
(males only) |
|
Impotence
|
2.8%
(males only) |
<1%
(males only) |
|
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.
VITAL SIGN CHANGES
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.
WEIGHT CHANGES
Patients treated with Celexa in controlled trials experienced a weight loss of about 0.5 kg compared to no change for placebo patients.
LABORATORY CHANGES
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.
ECG CHANGES
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 2 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 la-bility, 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, grand mal convulsions, hemolytic anemia, hepatic necrosis, myoclonus, neuroleptic malignant syndrome, nystagmus, pancreatitis, priapism, prolactinemia, prothrombin decreased, QT prolonged, rhabdomyolysis, serotonin syndrome, spontaneous abortion, thrombocytopenia, thrombosis, ventricular arrhythmia, torsades de pointes, and withdrawal syndrome.
DRUG ABUSE AND DEPENDENCE
CONTROLLED SUBSTANCE CLASS
Celexa (citalopram HBr) is not a controlled substance.
PHYSICAL AND PSYCHOLOGICAL DEPENDENCE
Animal studies suggest that the abuse liability of Celexa is low. Celexa has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with Celexa did not reveal any drug-seeking behavior. However, these observations were not systematic and it is not possible to predict, on the basis of this limited experience, the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate Celexa patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO CELEXA
Below is a sample of reports where side effects / adverse reactions may be related to Celexa. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Celexa side effects / adverse reactions in 34 year old female
Reported by a individual with unspecified qualification from United States on 2007-01-03
Patient: 34 year old female weighing 90.7 kg (199.6 pounds)
Reactions: Agitation, Impaired Work Ability, Hypoaesthesia, Marital Problem, Tremor, Fatigue, Feeling Jittery, Disturbance in Attention, Genital Disorder Female, Sexual Dysfunction, Central Nervous System Stimulation, Tearfulness
Suspect drug(s):
Celexa
Possible Celexa side effects / adverse reactions in 27 year old male
Reported by a individual with unspecified qualification from United States on 2007-01-10
Patient: 27 year old male
Reactions: Restlessness, NO Therapeutic Response, Drug Interaction, Tardive Dyskinesia, Nervousness
Suspect drug(s):
Celexa
Dosage: 40 mg qd po
Administration route: Oral
Indication: Obsessive-Compulsive Disorder
Start date: 2005-02-01
End date: 2005-01-01
Risperdal
Indication: Schizoaffective Disorder
Start date: 2003-12-01
End date: 2005-01-01
Risperdal
Dosage: 37.5 mg im
Indication: Schizoaffective Disorder
Start date: 2003-12-01
End date: 2005-01-01
Possible Celexa side effects / adverse reactions in 50 year old female
Reported by a individual with unspecified qualification from Canada on 2007-01-10
Patient: 50 year old female weighing 72.6 kg (159.7 pounds)
Reactions: Tinnitus, Hyperacusis
Suspect drug(s):
Celexa
Possible Celexa side effects / adverse reactions in 74 year old female
Reported by a pharmacist from United States on 2007-01-16
Patient: 74 year old female weighing 33.0 kg (72.6 pounds)
Reactions: Dystonia, Pain, Sepsis
Suspect drug(s):
Celexa
Dosage: 20 mg daily po [several months]
Administration route: Oral
Indication: Depression
Zyvox
Dosage: 600 mg bid po
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Start date: 2006-12-05
Possible Celexa side effects / adverse reactions in 44 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-18
Patient: 44 year old female
Reactions: Confusional State, Drug Toxicity, Incorrect Dose Administered, Pulmonary Oedema, Multiple Drug Overdose, Suicidal Ideation, Lethargy
Adverse event resulted in: death
Suspect drug(s):
Alprazolam
Dosage: 1 mg, prn
Indication: Agitation
End date: 2005-01-01
Celexa
Dosage: 60 mg, bid, oral; 60 mg, qd, oral; 60 mg, bid, oral; 60 mg, qd, oral
Administration route: Oral
Indication: Major Depression
Start date: 2005-01-01
End date: 2005-01-01
Celexa
Dosage: 60 mg, bid, oral; 60 mg, qd, oral; 60 mg, bid, oral; 60 mg, qd, oral
Administration route: Oral
Indication: Major Depression
Start date: 2005-01-01
End date: 2005-01-01
Celexa
Dosage: 60 mg, bid, oral; 60 mg, qd, oral; 60 mg, bid, oral; 60 mg, qd, oral
Administration route: Oral
Indication: Major Depression
End date: 2005-01-01
Methadose
Dosage: 20 mg, bid, oral
Administration route: Oral
Indication: Pain
End date: 2005-01-01
Possible Celexa side effects / adverse reactions in 31 year old female
Reported by a physician from United States on 2007-01-19
Patient: 31 year old female weighing 80.3 kg (176.6 pounds)
Reactions: Drug Exposure During Pregnancy, Haemorrhoids, Pregnancy, Premature Labour, Sinusitis
Adverse event resulted in: hospitalization
Suspect drug(s):
Celexa
Dosage: 20 mg qd po
Administration route: Oral
Indication: Anxiety
Start date: 2004-06-06
Celexa
Dosage: 20 mg qd po
Administration route: Oral
Indication: Depression
Start date: 2004-06-06
Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W/ Folic Acid CAP
Possible Celexa side effects / adverse reactions in 66 year old female
Reported by a physician from United States on 2007-01-19
Patient: 66 year old female
Reactions: Blood Sodium Increased, Generalised Oedema
Adverse event resulted in: hospitalization
Suspect drug(s):
Celexa
Other drugs received by patient: Acarbose
Possible Celexa side effects / adverse reactions in 27 year old male
Reported by a individual with unspecified qualification from United States on 2007-01-22
Patient: 27 year old male weighing 120.2 kg (264.4 pounds)
Reactions: Anxiety, Completed Suicide, Treatment Noncompliance
Adverse event resulted in: death
Suspect drug(s):
Celexa
Possible Celexa side effects / adverse reactions in 31 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-30
Patient: 31 year old female weighing 52.2 kg (114.8 pounds)
Reactions: Vomiting, Dizziness, Unevaluable Event
Suspect drug(s):
Celexa
Possible Celexa side effects / adverse reactions in 36 year old female
Reported by a physician from United States on 2007-02-07
Patient: 36 year old female
Reactions: Cholelithiasis, Postoperative Fever, White Blood Cell Count Increased
Suspect drug(s):
Celexa
Dosage: 20 mg qd oral
Administration route: Oral
Indication: Depression
Provigil
Indication: Sleep Disorder
Start date: 2006-07-01
Possible Celexa side effects / adverse reactions in 51 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2007-02-07
Patient: 51 year old male weighing 133.8 kg (294.4 pounds)
Reactions: Anxiety, Anorexia
Suspect drug(s):
Celexa
Celexa
Other drugs received by patient: Alprazolam; Alprazolam
Possible Celexa side effects / adverse reactions in 51 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2007-02-07
Patient: 51 year old male weighing 133.8 kg (294.4 pounds)
Reactions: Anxiety
Suspect drug(s):
Celexa
Possible Celexa side effects / adverse reactions in 22 year old female
Reported by a consumer/non-health professional from United States on 2007-02-16
Patient: 22 year old female
Reactions: Impaired Driving Ability, Abnormal Behaviour, Feeling Abnormal
Suspect drug(s):
Celexa
Other drugs received by patient: Ambien
Possible Celexa side effects / adverse reactions in 16 year old female
Reported by a individual with unspecified qualification from United States on 2007-02-23
Patient: 16 year old female weighing 77.1 kg (169.6 pounds)
Reactions: Dyspnoea, Overdose, Chest Pain, Suicide Attempt, Depression
Suspect drug(s):
Celexa
Dosage: 40 mg, qd, oral
Administration route: Oral
Indication: Depression
Claravis
Dosage: 80 mg, qd, oral, 40 mg, qd, oral
Administration route: Oral
Indication: Acne
Start date: 2006-12-01
End date: 2007-01-01
Claravis
Dosage: 80 mg, qd, oral, 40 mg, qd, oral
Administration route: Oral
Indication: Acne
Start date: 2007-01-01
End date: 2007-02-11
Other drugs received by patient: Levora 0.15/30-28; Advair Diskus 100/50; Albuterol
Possible Celexa side effects / adverse reactions in 74 year old female
Reported by a consumer/non-health professional from United States on 2007-03-02
Patient: 74 year old female
Reactions: Mania, Overdose, Blood Sodium Decreased
Adverse event resulted in: hospitalization
Suspect drug(s):
Celexa
Dosage: 25 mg qd po
Administration route: Oral
Indication: Depression
Start date: 2006-03-01
End date: 2006-05-23
Celexa
Dosage: 20 mg qd po
Administration route: Oral
Indication: Depression
End date: 2006-03-01
Other drugs received by patient: Cartia XT; Lisinopril; Potassium Acetate; Hydrochlorothiazide; Centrum; Aspirin
Possible Celexa side effects / adverse reactions in 22 year old female
Reported by a consumer/non-health professional from United States on 2007-03-09
Patient: 22 year old female
Reactions: Impaired Driving Ability, Imprisonment, Abnormal Behaviour
Suspect drug(s):
Celexa
Other drugs received by patient: Ambien
Possible Celexa side effects / adverse reactions in 42 year old male
Reported by a physician from United States on 2007-03-19
Patient: 42 year old male
Reactions: Weight Decreased, Renal Disorder, Blood Magnesium Decreased, Anxiety, Fatigue, Renal Failure, Blood Potassium Decreased, Renal Tubular Acidosis
Adverse event resulted in: hospitalization
Suspect drug(s):
Celexa
Dosage: 10 mg qd po
Administration route: Oral
Indication: Anxiety
Start date: 2006-02-01
End date: 2006-07-01
Celexa
Dosage: 10 mg qd po
Administration route: Oral
Indication: Anxiety
Start date: 2006-07-01
End date: 2007-02-01
Other drugs received by patient: Atenolol; Ibuprofen; Pain Medications (Nos)
Possible Celexa side effects / adverse reactions in 33 year old male
Reported by a physician from United States on 2007-03-27
Patient: 33 year old male
Reactions: Completed Suicide, GUN Shot Wound
Adverse event resulted in: death
Suspect drug(s):
Celexa
Dosage: 20 mg qd po
Administration route: Oral
Indication: Anxiety
Start date: 2007-02-09
End date: 2007-02-20
Celexa
Dosage: 20 mg qd po
Administration route: Oral
Indication: Depression
Start date: 2007-02-09
End date: 2007-02-20
Klonopin
Dosage: 0.5 mid bid
Indication: Anxiety
Start date: 2007-02-07
End date: 2007-02-20
Possible Celexa side effects / adverse reactions in 73 year old female
Reported by a individual with unspecified qualification from Denmark on 2007-03-27
Patient: 73 year old female
Reactions: Dyspnoea, Balance Disorder, Hypotension, Dizziness
Suspect drug(s):
Celexa
Dosage: 40 mg qd; po
Administration route: Oral
Xanax
Dosage: 0.25 mg qid; po
Administration route: Oral
Other drugs received by patient: Glucosamine with Chondroitin
Possible Celexa side effects / adverse reactions in 44 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2007-03-28
Patient: 44 year old female
Reactions: Thinking Abnormal, Suicide Attempt
Suspect drug(s):
Celexa
Dosage: 60 mg
Effexor XR
Dosage: 37.5 mg
Other drugs received by patient: Clonazepam; Dextroamphetamine (Dexamfentamine)
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