Over-the-counter medication · Second-Generation Antihistamine
loratadine
Also sold as Claritin. This medicine treats allergy symptoms.
Data updated 2026-05-15
- 104,378
- FDA reportsOften reported
- 1
- Recall record
What the data shows
loratadine (Claritin) is an over-the-counter Second-Generation Antihistamine, more reported than most tracked drugs (104,378 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
loratadine (Claritin) is an over-the-counter Second-Generation Antihistamine. This medicine treats allergy symptoms.
Loratadine is an antihistamine medicine. It helps relieve allergy symptoms.
Verify with FDA → · CMS NADAC pricing →
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
No specific warnings noted. Always follow your prescriber's instructions.
The sections below are summarized in plain English from loratadine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of loratadine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
If you are pregnant or breastfeeding, talk to your doctor before taking loratadine. They can help you weigh the risks and benefits.
This is a plain-language summary of loratadine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of loratadine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store between 68° to 77°F (20° to 25°C).
Side Effects (from patient reports)
Based on 104,378 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for loratadine, by number of reports
- Tiredness
Tiredness
6,401 reports
- Feeling sick to your stomach
Feeling sick to your stomach
5,688 reports
- Head pain
Head pain
5,182 reports
- Difficulty breathing
Difficulty breathing
4,656 reports
- Loose stools
Loose stools
4,654 reports
- Feeling lightheaded
Feeling lightheaded
4,216 reports
- Aches
Aches
3,991 reports
- Skin eruption
Skin eruption
3,317 reports
- Itching
Itching
3,199 reports
- Coughing
Coughing
2,935 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for loratadine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where loratadine sits
loratadine has more FDA adverse-event reports than 86% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is loratadine; the line is the median (50th percentile).
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
Reports Mentioning Death
4,537
4.3% of reports — not proof of cause
Hospitalization Reports
22,504
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | FATIGUE | 6,414 |
| 3 | NAUSEA | 5,699 |
| 4 | HEADACHE | 5,201 |
| 5 | DYSPNOEA | 4,664 |
| 6 | DIARRHOEA | 4,663 |
| 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 |
| 16 | ASTHENIA | 2,679 |
| 17 | ANXIETY | 2,646 |
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
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 104,378 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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