Celexa Adverse Reactions
Celexa (Citalopram) Adverse Reactions
- abdominal pain
- agitation
- akathisia
- amenorrhea
- amnesia
- anaphylactic shock
- anaphylactoid reactions
- angioedema
- anorexia
- anxiety
- appetite stimulation
- arthralgia
- asthenia
- blurred vision
- chest pain (unspecified)
- choreoathetosis
- coagulopathy
- confusion
- cough
- depression
- diaphoresis
- diarrhea
- dizziness
- drowsiness
- dysgeusia
- dysmenorrhea
- dyspepsia
- ejaculation dysfunction
- erythema multiforme
- fatigue
- fetal abortion
- fever
- flatulence
- GI bleeding
- headache
- hemolytic anemia
- hepatic necrosis
- hostility
- hyperprolactinemia
- hyponatremia
- hypotension
- impaired cognition
- impotence
- infection
- insomnia
- libido decrease
- maculopapular rash
- mania
- myalgia
- nausea/vomiting
- neonatal abstinence syndrome
- neuroleptic malignant syndrome
- orgasm dysfunction
- orthostatic hypotension
- pancreatitis
- paresthesias
- polyuria
- priapism
- pruritus
- QT prolongation
- renal failure (unspecified)
- rhabdomyolysis
- rhinitis
- seizures
- serotonin syndrome
- SIADH
- sinus tachycardia
- sinusitis
- suicidal ideation
- thrombocytopenia
- thrombosis
- torsade de pointes
- toxic epidermal necrolysis
- tremor
- ventricular fibrillation
- ventricular tachycardia
- weakness
- weight gain
- weight loss
- withdrawal
- xerostomia
- yawning
Celexa (Citalopram) Adverse Reactions
The potential relationship between the dose of citalopram administered and the incidence of adverse events was examined in a fixed-dose study in depressed patients receiving placebo or 10, 20, 40, or 60 mg of citalopram. A positive dose-dependent relationship (p <0.05) was reported for the following adverse events: diaphoresis, drowsiness, fatigue, impotence, and insomnia.
Among 1063 depressed patients who received citalopram 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 patients receiving placebo. The following adverse events were associated with drug discontinuation in 1-4% of citalopram-treated patients and at a rate at least twice that of placebo: agitation, asthenia/weakness, dizziness, drowsiness, insomnia, nausea/vomiting, and xerostomia. The following adverse events occurred in >= 2% of citalopram-treated patients and at an incidence greater than that reported among placebo-treated patients: abdominal pain (3% vs. 1%), agitation (3% vs. 1%), anorexia (4% vs. 2%), anxiety (4% vs. 3%), arthralgia (2% vs. 1%), diaphoresis (11% vs. 9%), diarrhea (8% vs. 5%), drowsiness (18% vs. 10%), dysmenorrhea (3% vs. 2%), dyspepsia (5% vs. 4%), ejaculation dysfunction (6% vs. 1%), fatigue (5% vs. 3%), fever (2% vs. <1%), impotence (3% vs. <1%), insomnia (15% vs. 14%), libido decrease (2% vs. <1%), myalgia (2% vs. 1%), nausea/vomiting (21% vs. 14% and 4% vs. 3%), rhinitis (5% vs. 3%), sinusitis (3% vs. <1%), tremor (8% vs. 6%), yawning (2% vs. 1%), upper respiratory tract infection (5% vs. 4%),and xerostomia (20% vs. 14%).
During premarketing evaluation of citalopram, 4422 patients received the drug at doses ranging from 10 to 80 mg/day. Although a causal relationship has not been determined, the following reported adverse events occurred at an incidence of >= 1% during treatment with citalopram: amenorrhea, amnesia, apathy, appetite stimulation, blurred vision, impaired cognition, confusion, cough, depression, flatulence, hypotension or orthostatic hypotension, migraine headache, paresthesias, polyuria, postural hypotension, pruritus, maculopapular rash, salivation, suicidal ideation, sinus tachycardia, dysgeusia, weight gain, and weight loss. Akathisia has been noted in post-marketing reports. Suicide is always a risk with depressed adults or children, whether or not they are taking an antidepressant. Some of the pediatric suicides that have occurred with the SSRIs have been anecdotally associated with akathisia in the first weeks of therapy; however, pediatric clinical data is not available to verify these case reports. While causality with citalopram has not been determined, CNS symptoms such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania may be an indication of worsening depression or suicidal tendencies, and should be immediately reported to the health care provider.
During clinical trials, sexual dysfunction was observed in both male and female depressed patients receiving citalopram. In male patients (n=425), decreased libido, ejaculation dysfunction (ejaculatory delay), and impotence were reported at an incidence of 3.8%, 6.1%, and 2.8%, respectively. In female patients (n=638), the reported incidence of decreased libido and orgasm dysfunction (anorgasmia) was 1.3% and 1.1%, respectively. These side effect occurred in <= 1% of patients receiving placebo in clinical trials. Priapism has been reported rarely with all of the SSRIs, including citalopram. Although sexual dysfunction is often part of depression and other psychiatric disorders, there is increasing evidence that treatment with SSRIs may induce sexual side effects. Post-marketing experience has suggested that the frequency of sexual adverse events is actually much higher than reported during initial clinical trials. In fact, many physicians report an incidence of up to 90% based on their clinical experience. Prescribers are encouraged to discuss and inquire about these side effects in patients receiving citalopram.
Although citalopram is a relatively long-acting SSRI, withdrawal symptoms have been reported with abrupt or rapid discontinuation of short-acting SSRIs (e.g., sertraline). The most commonly reported SSRI withdrawal symptoms include fatigue, abdominal pain or nausea, dizziness/light-headedness, tremor, chills, diaphoresis, and incoordination. Other reported symptoms include dysphoric mood, impaired memory, insomnia, irritability, shock sensations, headache, paresthesia and agitation or aggression. Withdrawal symptoms usually begin 1-3 days after abrupt discontinuation of the SSRI and remit within 1-2 weeks. Significant withdrawal symptoms have been reported in only 3 out of 8 million patients treated with citalopram, while none have been reported with fluoxetine. The difference in the incidence of withdrawal symptoms among SSRIs is most likely due to differences in the half-lives of the active moieties. Nevertheless, gradual tapering is recommended during discontinuation of any SSRI to decrease or prevent the occurrence of withdrawal symptoms. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Citalopram, like all SSRIs, can cause a syndrome of inappropriate secretion of antidiuretic hormone (SIADH) that presents as hyposmolarity of serum and urine, and hyponatremia. Older patients and those receiving diuretics or who are otherwise predisposed to dehydration appear to be more at risk. Discontinuation of the drug and/or medical intervention resolves these events.
Serotonin syndrome has been reported when SSRIs are administered concomitantly with other medications known to increase CNS or peripheral serotonin levels or during SSRI overdose. Symptoms may include nausea, vomiting, sedation, dizziness, diaphoresis (sweating), facial flush, mental status changes, mental status changes, myoclonia, restlessness, shivering, and hypertension.
Post-marketing reports have identified rare (occurring in <= 3 patients) adverse reactions that have been temporally associated with citalopram, but no causal association has been made. The reactions include: anaphylactic shock, anaphylactoid reactions, angioedema, chest pain (unspecified), choreoathetosis, coagulopathy, dyskinesia, ecchymosis, erythema multiforme, fetal abortion, GI bleeding, hemolytic anemia, hepatic necrosis, hyperprolactinemia, neuroleptic malignant syndrome, nystagmus, pancreatitis, QT prolongation, renal failure (unspecified), rhabdomyolysis, seizures, thrombocytopenia, thrombosis, torsade de pointes, toxic epidermal necrolysis, ventricular fibrillation, and ventricular tachycardia.
A neonatal abstinence syndrome has been reported in infants exposed to serotonergic agents in utero. After birth, symptoms consistent with withdrawal (i.e., poor feeding, hypoglycemia, hypothermia, lethargy or irritability, vomiting, etc.) were noted. Such complications can arise immediately upon delivery. Other symptoms have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, and constant crying. Serum concentrations of the serotonergic agent were measurable in the infants affected. Several other symptoms (bloody stools, necrotizing enterocolitis) may have been attributable to rebound platelet activation on withdrawal of the exposure to the SSRI. Neonatal symptoms generally improved over several days. Additionally, a cohort study of 55 women revealed that 22% (12/55) of neonates exposed to an SSRI in the third trimester had complications requiring treatment or extended hospitalization compared with 6% in comparison groups. Complications included respiratory distress (n=9), hypoglycemia (n=2) and jaundice (n=1).
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