Loratadine Side Effects

For the Consumer

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]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer