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Claritin

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The 16-year-old had his first reaction to peanut butter at 9 months of age when he broke out in hiv"...

Claritin

Claritin Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Claritin (loratadine) is an antihistamine medication that is used to treat allergy symptoms. Claritin is available as a generic drug, called loratadine. Claritin blocks the action of histamine, a substance in the body that initiates allergic symptoms like itching, sneezing, runny nose, and allergic skin rashes. Some common side effects of Claritin include headache, sleepiness, fatigue, and dry mouth.

Claritin is available as a 10 mg tablet, a 5 or 10 mg rapidly-disintegrating tablet, a 10 mg chewable tablet, and a syrup (5 mg per 5 ml). Claritin is taken once a day. Drug interactions may occur with certain antibiotics, antifungal medications, and acid-reducing drugs. Warnings may apply to individuals who have asthma, kidney disease, or liver disease. People who have phenylketonuria (PKU) should avoid certain brands of orally disintegrating tablets that may contain aspartame. Claritin is generally avoided during pregnancy and nursing. Pregnant women may take Claritin only if it is clearly needed. Nursing mothers should consult their doctor before breastfeeding. Claritin should not be used in children younger than 6 years of age unless directed by a doctor. Chewable tablets should not be used in children younger than 2 years of age unless directed by a pediatric doctor.

Our Claritin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Claritin in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fast or uneven heart rate;
  • feeling like you might pass out;
  • jaundice (yellowing of your skin or eyes); or
  • seizures (convulsions).

Less serious side effects may include:

  • headache;
  • nervousness;
  • feeling tired or drowsy;
  • stomach pain, diarrhea;
  • dry mouth, sore throat hoarseness;
  • eye redness, blurred vision;
  • nosebleed; or
  • skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Claritin (Loratadine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Claritin Overview - Patient Information: Side Effects

SIDE EFFECTS: This drug usually has no side effects. If you have any unusual effects, contact your doctor or pharmacist promptly.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Claritin (Loratadine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Claritin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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) .

Read the entire FDA prescribing information for Claritin (Loratadine) »

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Claritin - User Reviews

Claritin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Claritin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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