No black box warning on record for Claritin

As of the latest FDA labeling reviewed, Claritin (loratadine) does not carry a black box warning. Standard warnings and precautions still apply — see the full Claritin medicine page for the complete safety profile.

Other warnings & precautions

Hepatic impairment: Loratadine is extensively metabolized by the liver to its active metabolite descarboethoxyloratadine (desloratadine). Patients with any degree of hepatic impairment should use 10 mg every other day; severe impairment may require further monitoring and dose reduction
Renal impairment: In patients with GFR <30 mL/min, reduce dosing frequency to every other day (10 mg every 48 hours) to prevent accumulation of the active metabolite
Hypersensitivity: Contraindicated in patients with known hypersensitivity to loratadine or any component of the formulation; cross-reactivity within the piperidine antihistamine class is possible
Claritin-D (loratadine/pseudoephedrine) — cardiovascular risks: The pseudoephedrine component is contraindicated in patients with severe hypertension, severe coronary artery disease, or those taking MAO inhibitors within 14 days due to risk of hypertensive crisis and cardiac events
Claritin-D — urinary retention: Pseudoephedrine-containing formulations should be used with extreme caution in males with benign prostatic hyperplasia (BPH) due to risk of acute urinary retention
Narrow-angle glaucoma: The pseudoephedrine-containing Claritin-D formulations should be avoided in patients with narrow-angle glaucoma; plain loratadine has minimal anticholinergic effects and is generally safe
Pregnancy: Category B — loratadine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; epidemiological data have not demonstrated increased risk of major malformations
Breastfeeding: Loratadine and its active metabolite are excreted in human breast milk in small amounts; the clinical decision to discontinue breastfeeding or the drug should account for the infant's age, maternal benefit, and level of drug exposure
Pediatric use (under 2 years): Safety and efficacy have not been established in children under 2 years of age; do not use without direct medical supervision in this age group
Drug interactions with CYP inhibitors: Concurrent use of strong CYP3A4 or CYP2D6 inhibitors can markedly increase loratadine plasma concentrations; dose adjustment or closer monitoring is required in such patients

Other warnings & precautions

Hepatic impairment: Loratadine is extensively metabolized by the liver to its active metabolite descarboethoxyloratadine (desloratadine). Patients with any degree of hepatic impairment should use 10 mg every other day; severe impairment may require further monitoring and dose reduction

Renal impairment: In patients with GFR <30 mL/min, reduce dosing frequency to every other day (10 mg every 48 hours) to prevent accumulation of the active metabolite

Hypersensitivity: Contraindicated in patients with known hypersensitivity to loratadine or any component of the formulation; cross-reactivity within the piperidine antihistamine class is possible

Claritin-D (loratadine/pseudoephedrine) — cardiovascular risks: The pseudoephedrine component is contraindicated in patients with severe hypertension, severe coronary artery disease, or those taking MAO inhibitors within 14 days due to risk of hypertensive crisis and cardiac events

Claritin-D — urinary retention: Pseudoephedrine-containing formulations should be used with extreme caution in males with benign prostatic hyperplasia (BPH) due to risk of acute urinary retention

Narrow-angle glaucoma: The pseudoephedrine-containing Claritin-D formulations should be avoided in patients with narrow-angle glaucoma; plain loratadine has minimal anticholinergic effects and is generally safe

Pregnancy: Category B — loratadine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; epidemiological data have not demonstrated increased risk of major malformations

Breastfeeding: Loratadine and its active metabolite are excreted in human breast milk in small amounts; the clinical decision to discontinue breastfeeding or the drug should account for the infant's age, maternal benefit, and level of drug exposure

Pediatric use (under 2 years): Safety and efficacy have not been established in children under 2 years of age; do not use without direct medical supervision in this age group

Drug interactions with CYP inhibitors: Concurrent use of strong CYP3A4 or CYP2D6 inhibitors can markedly increase loratadine plasma concentrations; dose adjustment or closer monitoring is required in such patients

Claritin Black Box Warning

No black box warning on record for Claritin

Other warnings & precautions

Claritin Black Box Warning

No black box warning on record for Claritin

Other warnings & precautions