Citalopram (Page 4 of 11)

Dose Dependent Adverse Reactions

The potential relationship between the dosage of citalopram tablets and the incidence of adverse reactions was examined in a fixed-dose study in patients with MDD receiving placebo or citalopram tablets 10 mg, 20 mg, 40 mg, or 60 mg (1.5 times the maximum recommended dosage). A positive dose response (p < 0.05) was revealed for the following adverse reactions: fatigue, impotence, insomnia, increased sweating, 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 SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.

Table 4 displays the incidence of sexual adverse reactions reported by at least 2% of male patients taking citalopram tablets in a pool of placebo-controlled clinical trials in patients with depression.

Table 4: Adverse Reactions (≥ 2%) Related to Sexual Dysfunction in Citalopram Tablets-Treated Male Patients in Pooled Placebo-Controlled Clinical Trials of MDD

Citalopram Tablets

Placebo

n (males)

425

(%)

194

(%)

Abnormal ejaculation

(mostly ejaculatory delay)

6.1

1

Decreased libido

3.8

< 1

Impotence

2.8

< 1

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.

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.

ECG Changes

In a thorough QT study, citalopram tablets were found to be associated with a dose-dependent increase in the QTc interval.

Electrocardiograms from citalopram tablets (N = 802) and placebo (N = 241) groups were compared with respect to outliers defined as subjects with QTc changes over 60 msec from baseline or absolute values over 500 msec post-dose, and subjects with heart rate increases to over 100 bpm or decreases to less than 50 bpm with a 25% change from baseline (tachycardic or bradycardic outliers, respectively). In the citalopram tablets group 1.9% of the patients had a change from baseline in QTcF > 60 msec compared to 1.2% of the patients in the placebo group. None of the patients in the placebo group had a post-dose QTcF > 500 msec compared to 0.5% of the patients in the citalopram tablets group. The incidence of tachycardic outliers was 0.5% in the citalopram tablets group and 0.4% in the placebo group. The incidence of bradycardic outliers was 0.9% in the citalopram tablets group and 0.4% in the placebo group.

Other Adverse Reactions Observed During the Premarketing Evaluation of Citalopram Tablets

The following list of adverse reactions does not include reactions that are: 1) included in Table 3 or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, and those occurring in only one patient.

Adverse reactions are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in less than 1/100 patients to 1/1000 patients; rare adverse reactions 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, hypoesthesia, 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:hay fever.

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:abnormal accommodation, 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.

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