loratadine
Brand names: Claritin
Loratadine is an antihistamine medicine. It helps relieve allergy symptoms.
Drug Pricing (NADAC)
Generic Price
$0.65/unit
Generic Available
Yes (31 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats allergy symptoms.
Common side effects
Headache, Fatigue, Drowsiness
Key warnings
There are no boxed warnings for this medication.
How It Works
Loratadine blocks histamine in your body. Histamine is a natural substance that causes allergy symptoms. By blocking it, loratadine reduces these symptoms.
How to Take It
Adults and children 6 years and over should take 1 tablet daily. Do not take more than 1 tablet in 24 hours. Ask a doctor before giving to children under 6 years. If you have liver or kidney disease, ask a doctor before taking this medicine.
Pregnancy & Breastfeeding
If you are pregnant or breastfeeding, talk to your doctor before taking loratadine. They can help you weigh the risks and benefits.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store between 68° to 77°F (20° to 25°C).
Side Effects (from patient reports)
Based on 55,234 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 104,378 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
104,378
Death-Related Reports
4,537
Hospitalization Reports
22,504
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 12,885 |
| 2 | FATIGUE | 6,414 |
| 3 | NAUSEA | 5,699 |
| 4 | HEADACHE | 5,201 |
| 5 | DYSPNOEA | 4,664 |
| 6 | DIARRHOEA | 4,663 |
| 7 | OFF LABEL USE | 4,497 |
| 8 | DIZZINESS | 4,236 |
| 9 | PAIN | 3,996 |
| 10 | RASH | 3,323 |
| 11 | PRURITUS | 3,208 |
| 12 | COUGH | 2,944 |
| 13 | SOMNOLENCE | 2,917 |
| 14 | VOMITING | 2,915 |
| 15 | ARTHRALGIA | 2,769 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
There are no boxed warnings for this medication.
Common Questions
Can children take loratadine?
Can I take more than one tablet a day?
What should I do if I have liver or kidney disease?
What if the foil seal under the cap is broken?
Does loratadine make you sleepy?
Can I take loratadine with other allergy medicines?
How quickly does loratadine work?
Can I drive while taking loratadine?
Can I drink alcohol while taking loratadine?
What if loratadine doesn't relieve my symptoms?
What are the common side effects of loratadine?
What drug class is loratadine?
Is loratadine safe during pregnancy?
Has loratadine been recalled?
Active Recalls
CGMP Deviations: product held outside appropriate storage temperature conditions.
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Related Medications in Second-Generation Antihistamine
Other drugs grouped near loratadine — same-class peers and common alternatives.
azelastine
Astelin, Astepro
Azelastine nasal spray is an antihistamine medicine.
Compare with loratadine →
budesonide nasal
Rhinocort
Rhinocort is a nasal spray that helps relieve allergy symptoms.
Compare with loratadine →
cetirizine
Zyrtec
Cetirizine (Zyrtec) is an antihistamine medicine.
Compare with loratadine →
chlorpheniramine
Chlor-Trimeton
Chlorpheniramine is an antihistamine medicine.
Compare with loratadine →
ciclesonide nasal
Omnaris, Zetonna
Omnaris Nasal Spray is a medicine that helps treat allergy symptoms in your nose.
Compare with loratadine →
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What the FDA Data Shows for loratadine
The FDA label for loratadine (sold under brand names such as Claritin) classifies it as an over-the-counter product in the Second-Generation Antihistamine class. This medicine treats allergy symptoms. Official labeling lists 3 commonly reported side effects, including Headache, Fatigue, Drowsiness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 55,234 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.65.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: September 4, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages