Side Effects of Claritin D

Claritin-D (loratadine/pseudoephedrine) is a combination of an antihistamine and a decongestant used to temporarily relieve a runny nose, sneezing, and nasal stuffiness from a common cold. It also is used to relieve nasal and non-nasal symptoms of a variety of allergic conditions like seasonal allergic rhinitis. 

Loratadine is a long-acting antihistamine that blocks the actions of histamine that causes some of the symptoms of allergic reactions. Histamine is released from histamine-storing cells (mast cells) and attaches to other cells that have receptors for histamine on their surfaces. 

Histamine stimulates the cells to release chemicals that produce effects that are associated with allergy symptoms. Loratadine blocks one type of histamine receptor (the H1 receptor) and thus prevents activation of cells with H1 receptors by histamine. 

Unlike some antihistamines, loratadine does not enter the brain from the blood and, therefore, does not cause drowsiness when taken at recommended doses. It is one of a few antihistamines that do not cause sedation. 

Pseudoephedrine relieves congestion by causing blood vessels to constrict. Claritin-D is available in generic form and is available over-the-counter (OTC) without a prescription.

Drug interactions of Claritin-D include monoamine oxidase inhibitors (MAOIs). Erythromycin, cimetidine, itraconazole, and ketoconazole increase the blood concentration of loratadine by inhibiting the elimination of loratadine. This may result in increased adverse events from loratadine. St. John's wort, carbamazepine, and rifampin reduce blood levels of loratadine. 

Patients who are or may become pregnant should be told that Claritin-D should be used in pregnancy or during lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant. 

Pseudoephedrine is secreted in breast milk. Loratadine is secreted in breast milk at levels similar to blood levels. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breastfeeding. 

Nursing mothers should decide whether to stop breastfeeding or discontinue Claritin-D. Consult your doctor before breastfeeding.

What are the common side effects of Claritin-D?

Common side effects of Claritin-D include stimulation of the nervous system leading to

• nervousness,
• restlessness,
• excitability,
• dizziness,
• headache,
• fear, and
• anxiety.

What are the serious side effects of Claritin-D?

Serious side effects of Claritin-D include

• tremor,
• hallucinations, and
• convulsions (seizures).

• No specific interaction studies have been conducted with loratadine; pseudoephedrine extended release tablets. However, loratadine (10 mg once daily) has been safely coadministered with therapeutic doses of erythromycin, cimetidine, and ketoconazole in controlled clinical pharmacology studies.
• Although increased plasma concentrations (AUC 0-24 hrs) of loratadine and/or descarboethoxyloratadine were observed following coadministration of loratadine with each of these drugs in normal volunteers (n=24 in each study), there were no clinically relevant changes in the safety profile of loratadine, as assessed by electrocardiographic parameters, clinical laboratory tests, vital signs, and adverse events.
• There was no significant effects on QT_c intervals, and no reports of sedation of syncope.
• No effects on plasma concentrations of cimetidine or ketoconazole were observed. Plasma concentrations (AUC 0-24 hrs) of erythromycin decreased 15% with coadministration of loratadine relative to that observed with erythromycin alone.
• The clinical relevance of this difference is unknown. 
• There does not appear to be an increase in adverse events in subjects who received oral contraceptives and loratadine.
• Loratadine; pseudoephedrine sulfate extended release tablets (pseudoephedrine component) are contraindicated in patients taking monoamine oxidase inhibitors and for 2 weeks after stopping use of an MAO inhibitor.
• The antihypertensive effects of beta-adrenergic blocking agents, methyldopa, mecamylamine, reserpine, and veratrum alkaloids may be reduced by sympathomimetics.
• Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis.

• 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.

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%).

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.

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.

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.