Claritin Reditabs

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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 (the active ingredient contained in Claritin Reditabs) pseudoephedrine sulfate preparations: Insomnia, dry mouth, headache, somnolence, nervousness, dizziness, fatigue.

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]

Some side effects of Claritin Reditabs may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.