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Applies to loratadine: oral fixed-combination tablets, oral orally disintegrating tablets, oral solution, oral tablets
Side effects include:
Children 2–5 years of age receiving oral solution: Diarrhea, epistaxis, pharyngitis, flu-like symptoms, fatigue, stomatitis, tooth disorder, earache, viral infection, rash.
Children 6–12 years of age receiving oral solution: Nervousness, wheezing, fatigue, hyperkinesia, abdominal pain, conjunctivitis, dysphonia, upper respiratory tract infection.
Adults and children ≥12 years of age receiving conventional or orally disintegrating tablets: Headache, somnolence, fatigue, dry mouth.
Fixed combination loratadine/pseudoephedrine sulfate preparations: Insomnia, dry mouth, headache, somnolence, nervousness, dizziness, fatigue.For Healthcare Professionals
Applies to loratadine: oral capsule, oral syrup, oral tablet, oral tablet chewable, oral tablet disintegratingGeneral
The most commonly reported side effects included headache, somnolence nervousness, and fatigue.Nervous system
Very common (10% or more): Headache (up to 12%)
Common (1% to 10%): Sedation/somnolence
Very rare (less than 0.01%): Dizziness, convulsion
Frequency not reported: Syncope, paresthesiaPsychiatric
Common (1% to 10%): Nervousness
Uncommon (0.1% to 1%): Insomnia
Frequency not reported: Depression, paroniriaOther
Common (1% to 10%): Fatigue
Frequency not reported: Fever, viral infection, tinnitus, malaiseGastrointestinal
Common (1% to 10%): Dry mouth
Very rare (less than 0.01%): Nausea, gastritis
Frequency not reported: Dyspepsia, diarrhea, constipation, abdominal/gastric pain, altered taste, increased salivaMetabolic
Uncommon (0.1% to 1%): Increased appetiteDermatologic
Very rare (less than 0.01%): Angioedema, rash, alopecia
Frequency not reported: Pruritus, rash on faceGenitourinary
Frequency not reported: Increased frequency of urination, urine discoloration, menstruation delayCardiovascular
Very rare (less than 0.01%): Tachycardia, palpitation
Frequency not reported: Hypertension, hypotension, chest painHypersensitivity
Very rare (less than 0.01%): Hypersensitivity reactions, anaphylaxisHepatic
Very rare (less than 0.01%): Abnormal hepatic functionRespiratory
Frequency not reported: Epistaxis, nasal dryness, pharyngitis, coughingMusculoskeletal
Frequency not reported: Myalgia
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