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 disintegrating.

General

The most commonly reported side effects included headache, somnolence nervousness, and fatigue.^[Ref]

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, paresthesia^[Ref]

Psychiatric

Common (1% to 10%): Nervousness

Uncommon (0.1% to 1%): Insomnia

Frequency not reported: Depression, paroniria^[Ref]

Other

Common (1% to 10%): Fatigue

Frequency not reported: Fever, viral infection, tinnitus, malaise^[Ref]

Gastrointestinal

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 saliva^[Ref]

Metabolic

Uncommon (0.1% to 1%): Increased appetite^[Ref]

Dermatologic

Very rare (less than 0.01%): Angioedema, rash, alopecia

Frequency not reported: Pruritus, rash on face^[Ref]

Genitourinary

Frequency not reported: Increased frequency of urination, urine discoloration, menstruation delay^[Ref]

Cardiovascular

Very rare (less than 0.01%): Tachycardia, palpitation

Frequency not reported: Hypertension, hypotension, chest pain^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Hypersensitivity reactions, anaphylaxis^[Ref]

Hepatic

Very rare (less than 0.01%): Abnormal hepatic function^[Ref]

Respiratory

Frequency not reported: Epistaxis, nasal dryness, pharyngitis, coughing^[Ref]

Musculoskeletal

Frequency not reported: Myalgia^[Ref]