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CLARITIN (loratadine) Tablets: Approximately 90,000 patients, aged 12 and older, received CLARITIN (loratadine) Tablets 10 mg once daily in controlled and uncontrolled studies. Placebo-controlled clinical trials at the recommended dose of 10 mg once a day varied from 2 weeks' to 6 months' duration. The rate of premature withdrawal from these trials was approximately 2% in both the treated and placebo groups.

REPORTED ADVERSE EVENTS WITH AN INCIDENCE OF MORE THAN 2% IN PLACEBO-CONTROLLED ALLERGIC RHINITIS CLINICAL TRIALS IN PATIENTS 12 YEARS OF AGE AND OLDER PERCENT OF PATIENTS REPORTING
  LORATADINE 10 mg QD
n = 1926
PLACEBO
n = 2545
CLEMASTINE 1 mg BID
n = 536
TERFENADINE 60 mg BID
n = 684
Headache 12 11 8 8
Somnolence 8 6 22 9
Fatigue 4 3 10 2
Dry Mouth 3 2 4 3

Adverse events reported in placebo-controlled chronic idiopathic urticaria trials were similar to those reported in allergic rhinitis studies.

Adverse event rates did not appear to differ significantly based on age, sex, or race, although the number of nonwhite subjects was relatively small.

CLARITIN REDITABS (loratadine rapidly-disintegrating tablets): Approximately 500 patients received CLARITIN REDITABS (loratadine rapidly-disintegrating tablets) in controlled clinical trials of 2 weeks' duration. In these studies, adverse events were similar in type and frequency to those seen with CLARITIN (loratadine) Tablets and placebo.

Administration of CLARITINREDITABS(loratadine rapidly-disintegrating tablets) did not result in an increased reporting frequency of mouth or tongue irritation.

CLARITIN (loratadine) Syrup: Approximately 300 pediatric patients 6 to 12 years of age received 10 mg loratadine once daily in controlled clinical trials for a period of 8 to 15 days. Among these, 188 children were treated with 10 mg loratadine syrup once daily in placebo-controlled trials. Adverse events in these pediatric patients were observed to occur with type and frequency similar to those seen in the adult population. The rate of premature discontinuance due to adverse events among pediatric patients receiving loratadine 10 mg daily was less than 1%.

 

ADVERSE EVENTS OCCURRING WITH A FREQUENCY OF ≥ 2% IN LORATADINE SYRUP-TREATED PATIENTS (6 TO 12 YEARS OLD) IN PLACEBO-CONTROLLED TRIALS, AND MORE FREQUENTLY THAN IN THE PLACEBO GROUP PERCENT OF PATIENTS REPORTING
  LORATADINE 10 mg QD
n = 188
PLACEBO
n = 262
CHLORPHENIRAMINE 2-4 mg BID/TID
n = 170
Nervousness 4 2 2
Wheezing 4 2 5
Fatigue 3 2 5
Hyperkinesia 3 1 1
Abdominal Pain 2 0 0
Conjunctivitis 2 < 1 1
Dysphonia 2 < 1 0
Malaise 2 0 1
Upper Respiratory Tract Infection 2 < 1 0

Sixty pediatric patients 2 to 5 years of age received 5 mg loratadine once daily in a double-blind, placebo-controlled clinical trial for a period of 14 days. No unexpected adverse events were seen given the known safety profile of loratadine and likely adverse reactions for this patient population. The following adverse events occurred with a frequency of 2 to 3 percent in the loratadine syrup-treated patients (2 to 5 years old) during the placebo-controlled trial, and more frequently than in the placebo group: diarrhea, epistaxis, pharyngitis, influenza-like symptoms, fatigue, stomatitis, tooth disorder, earache, viral infection, and rash.

In addition to those adverse events reported above (≥ 2%), the following adverse events have been reported in at least one patient in CLARITIN (loratadine) clinical trials in adult and pediatric patients:

Autonomic Nervous System: altered lacrimation, altered salivation, flushing, hypoesthesia, impotence, increased sweating, thirst.

Body as a Whole: angioneurotic edema, asthenia, back pain, blurred vision, chest pain, earache, eye pain, fever, leg cramps, malaise, rigors, tinnitus, weight gain.

Cardiovascular System: hypertension, hypotension, palpitations, supraventricular tachyarrhythmias, syncope, tachy-cardia.

Central and Peripheral Nervous System: blepharospasm, dizziness, dysphonia, hypertonia, migraine, paresthesia, tremor, vertigo.

Gastrointestinal System: altered taste, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastritis, hiccup, increased appetite, loose stools, nausea, vomiting.

Musculoskeletal System: arthralgia, myalgia.

Psychiatric: agitation, amnesia, anxiety, confusion, decreased libido, depression, impaired concentration, insomnia, irritability, paroniria.

Reproductive System: breast pain, dysmenorrhea, menorrhagia, vaginitis.

Respiratory System: bronchitis, bronchospasm, coughing, dyspnea, hemoptysis, laryngitis, nasal dryness, sinusitis, sneezing.

Skin and Appendages: dermatitis, dry hair, dry skin, photosensitivity reaction, pruritus, purpura, urticaria. Urinary System: altered micturition, urinary discoloration, urinary incontinence, urinary retention.

In addition, the following spontaneous adverse events have been reported rarely during the marketing of loratadine: abnormal hepatic function, including jaundice, hepatitis, and hepatic necrosis; alopecia; anaphylaxis; breast enlargement; erythema multiforme; peripheral edema; thrombocytopenia; and seizures.

Drug Abuse And Dependence

There is no information to indicate that abuse or dependency occurs with CLARITIN (loratadine) .