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Claritin D

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Claritin D

Claritin D

Claritin D Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Claritin D (loratadine and pseudoephedrine) is a combination antihistamine and decongestant used to treat allergies, nasal congestion, and sinus pressure. It is available over-the-counter and in generic versions. Side effects can include dizziness, drowsiness, palpitations, dry mouth, headache, fatigue, nausea, nervousness, sleeplessness, and sore throat. Other more severe side effects may occur.

Claritin D is available in 12-hour and 24-hour dosing. Do not use if you are taking an MAOI or have taken an MAOI in the past 2 weeks. Claritin D should not be used by patients with severe high blood pressure (hypertension), glaucoma or severe coronary artery disease without physician supervision. If pregnant or breastfeeding, consult a doctor before use. Stop use if an allergic reaction occurs or symptoms do not resolve within 7 days.

Our Claritin D 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 D in Detail - Patient Information: Side Effects

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats, seizure);
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • blurred vision;
  • dry mouth;
  • nausea, stomach pain, constipation;
  • mild loss of appetite, stomach upset;
  • warmth, redness, or tingly feeling under your skin;
  • sleep problems (insomnia);
  • restless or excitability (especially in children);
  • skin rash or itching;
  • dizziness, drowsiness;
  • problems with memory or concentration; or
  • mild ringing in your ears.

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 D (Loratadine and Pseudoephedrine) »

What is Patient Information Overview?

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

Claritin D Overview - Patient Information: Side Effects

SIDE EFFECTS: Dry mouth, mild stomach upset, trouble sleeping, dizziness, headache, nervousness, loss of appetite, or thirst may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: fast/irregular heartbeat, uncontrolled shaking or tremor.

Tell your doctor immediately if any of these unlikely but serious side effects occur: seizures, mental/mood changes, difficulty urinating.

This medication does not usually cause drowsiness when used at recommended doses and under normal circumstances. However, this drug may make you dizzy; therefore use caution engaging in activities that require alertness such as driving or using machinery.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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 D (Loratadine and Pseudoephedrine)»

What is Prescribing information?

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

Claritin D FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Loratadine; Pseudoephedrine Sulfate 12 Hour Extended Release Tablets

Experience from controlled and uncontrolled clinical studies involving approximately 10,000 patients who received the combination of loratadine; pseudoephedrine sulfate for a period of up to 1 month provides information on adverse reactions. The usual dose was one tablet every 12 hours for up to 28 days.

In controlled clinical trials using the recommended dose of one tablet every 12 hours, the incidence of reported adverse events was similar to those reported with placebo, with the exception of insomnia (16%) and dry mouth (14%).

TABLE 2 Reported Adverse Events with an Incidence of ³2% in Loratadine; Pseudoephedrine Sulfate 12 Hour Extended Release Tablets in Placebo-Controlled Clinical Trials
Percent of Patients Reporting
  Loratadine; Pseudoephedrine Sulfate 12 Hour Loratadine Pseudoephedrine Placebo
  n=1023 n=543 n=548 n=922
 Headache 19 18 17 19
 Insomnia 16 4 19 3
 Dry Mouth 14 4 9 3
 Somnolence 7 8 5 4
 Nervousness 5 3 7 2
 Dizziness 4 1 5 2
 Fatigue 4 6 3 3
 Dyspepsia 3 2 3 1
 Nausea 3 2 3 2
 Pharyngitis 3 3 2 3
 Anorexia 2 1 2 1
 Thirst 2 1 2 1


Adverse event rates did not appear to differ significantly based on age, sex, or race, although the number of non-white subjects was relatively small.

In addition to those adverse events reported above (³2%), the following less frequent adverse events have been reported in at least one patient treated with loratadine; pseudoephedrine sulfate 12 hour extended release tablets.

Autonomic Nervous System: Abnormal lacrimation, dehydration, flushing, hypoesthesia, increased sweating, mydriasis.

Body as a Whole: Asthenia, back pain, blurred vision, chest pain, conjunctivitis, earache, ear infection, eye pain, fever, flu-like symptoms, leg cramps, lymphadenopathy, malaise, photophobia, rigors, tinnitus, viral infection, weight gain.

Cardiovascular System: Hypertension, hypotension, palpitations, peripheral edema, syncope, tachycardia, ventricular extrasystoles.

Central and Peripheral Nervous System: Dysphonia, hyperkinesia, hypertonia, migraine, paresthesia, tremors, vertigo.

Gastrointestinal System: Abdominal distension, abdominal distress, abdominal pain, altered taste, constipation, diarrhea, eructation, flatulence, gastritis, gingival bleeding, hemorrhoids, increased appetite, stomatitis, taste loss, tongue discoloration, toothache, vomiting.

Liver and Biliary System: Hepatic function abnormal.

Musculoskeletal System: Arthralgia, myalgia, torticollis.

Psychiatric: Aggressive reaction, agitation, anxiety, apathy, confusion, decreased libido, depression, emotional lability, euphoria, impaired concentration, irritability, paroniria.

Reproductive System: Dysmenorrhea, impotence, intermenstrual bleeding, vaginitis.

Respiratory System: Bronchitis, bronchospasm, chest congestion, coughing, dry throat, dyspnea, epistaxis, halitosis, nasal congestion, nasal irritation, sinusitis, sneezing, sputum increased, upper respiratory infection, wheezing.

Skin and Appendages: Acne, bacterial skin infection, dry skin, eczema, edema, epidermal necrolysis, erythema, hematoma, pruritus, rash, urticaria.

Urinary System: Dysuria, micturition frequency, nocturia, polyuria, urinary retention.

24 Hour Extended Release Tablets

Information on adverse reactions is provided from placebo-controlled studies involving over 2000 patients, 605 of whom received loratadine; pseudoephedrine sulfate 24 hour extended release tablets once daily for up to 2 weeks. In these studies, the incidence of adverse events reported with loratadine; pseudoephedrine sulfate 24 hour extended release tablets was similar to those reported with twice-daily (q12h) 120 mg sustained-release pseudoephedrine alone.

TABLE 3 Reported Adverse Events With an Incidence of ³2% in Loratadine; Pseudoephedrine Sulfate 24 Hour Extended Release Tablets Treatment Group in Double-Blind, Randomized, Placebo-Controlled Clinical Trials
Percent of Patients Reporting
  Loratadine; phedrine Sulfate 24 Hour Loratadine 10 mg Pseudoephedrine 120 mg q12h Placebo
  (n = 605) (n = 449) (n = 220) (n = 605)
 Dry Mouth 8 2 7 2
 Somnolence 6 4 5 4
 Insomnia 5 1 9 1
 Pharyngitis 5 5 5 5
 Dizziness 4 2 3 2
 Coughing 3 2 3 1
 Fatigue 3 4 1 2
 Nausea 3 2 4 2
 Nervousness 3 1 4 1
 Anorexia 2 <1 2  
 Dysmenorrhea 2 2 2 1


Adverse events occurring in greater than or equal to 2% of loratadine; pseudoephedrine sulfate 24 hour extended release tablets-treated patients, but that were more common in the placebo-treated group, include headache.

Adverse events did not appear to significantly differ based on age, sex, or race, although the number of nonwhites was relatively small.

In addition to those adverse events reported above, the following adverse events have been reported in fewer than 2% of patients who received loratadine; pseudoephedrine sulfate 24 hour extended release tablets.

Autonomic Nervous System: Altered lacrimation, flushing, increased sweating, mydriasis, thirst.

Body as a Whole: Abnormal vision, asthenia, back pain, chest pain, conjunctivitis, earache, eye pain, facial edema, fever, flu-like symptoms, leg cramps, lymphadenopathy, malaise, rigors, tinnitus.

Cardiovascular System: Hypertension, palpitation, tachycardia.

Central and Peripheral Nervous System: Convulsions, dysphonia, hyperkinesis, hypertonia, migraine, paresthesia, tremor.

Gastrointestinal System: Abdominal distension, altered taste, constipation, diarrhea, dyspepsia, flatulence, gastritis, stomatitis, tongue ulceration, toothache, vomiting.

Liver and Biliary System: Cholelithiasis.

Musculoskeletal System: Arthralgia, musculoskeletal pain, myalgia, tendinitis.

Psychiatric: Agitation, depression, emotional lability, irritability.

Reproductive System: Vaginitis.

Resistance Mechanism: Abscess, viral infection.

Respiratory System: Bronchospasm, dyspnea, epistaxis, hemoptysis, nasal congestion, nasal irritation, pleurisy, pneumonia, sinusitis, sputum increased, wheezing.

Skin and Appendages: Acne, pruritus.

Urinary System: Oliguria, micturition frequency, urinary retention, urinary tract infection.

Additional adverse events reported with the combination of loratadine and pseudoephedrine include abnormal hepatic function, aggressive reaction, anxiety, apathy, confusion, euphoria, paroniria, postural hypotension, syncope, urticaria, vertigo, weight gain.

There have been postmarketing reports of mechanical upper gastrointestinal tract obstruction and esophageal perforation in patients taking a previously marketing formulation of loratadine; pseudoephedrine sulfate 24 hour extended release tablets. In some, but not all, of these cases, patients have had known upper gastrointestinal narrowing or abnormal esophageal peristalsis. It is not known whether this reformulation of loratadine; pseudoephedrine sulfate 24 hour extended release tablets has the potential for this adverse event (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).

12 and 24 Hour Extended Release Tablets

The Following Additional Adverse Events Have Been Reported With Loratadine; Pseudoephedrine Sulfate Tablets: Alopecia, altered salivation, amnesia, anaphylaxis, angioneurotic edema, blepharospasm, breast enlargement, breast pain, dermatitis, dry hair, erythema multiforme, laryngitis, menorrhagia, nasal dryness, photosensitivity reaction, purpura, seizures, sneezing, supraventricular tachyarrhythmias, urinary discoloration. Additional Adverse Events for 24 Hour Extended Release Tablets Only: Abdominal distress, altered micturition, bronchitis, decreased libido, dry skin, hypoesthesia, impaired concentration, impotence, increased appetite, peripheral edema, rash, and upper respiratory infection.

Pseudoephedrine may cause mild CNS stimulation in hypersensitive patients. Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, drowsiness, tachycardia, palpitation, pressor activity, and cardiac arrhythmias have been reported. Sympathomimetic drugs have also been associated with other untoward effects, such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse.

DRUG ABUSE AND DEPENDENCE

There is no information to indicate that abuse or dependency occurs with loratadine. Pseudoephedrine, like other central nervous system stimulants, has been abused. At high doses, subjects commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased appetite. Some individuals become anxious, irritable, and loquacious. In addition to the marked euphoria, the user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use, tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdrawal.

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

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Claritin D - User Reviews

Claritin D 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 D 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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