Sold as Alavert, Claritin, Cleartime Indoor & Outdoor Allergies, Loradamed, Tavist Non-Sedating and 2 more.
First FDA approval 04/12/1993: 33 years on the US market.
This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
B
Score breakdown (78/100)
Safety ×35%
A
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
B
Options ×10%
C
Safety: 95
Death share in reports is near or below the FAERS average (0.4x)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 45
189 randomized trials and 6 systematic reviews/meta-analyses indexed in PubMed
On the WHO Model List of Essential Medicines (shown for context; no score effect)
No Cochrane review found (-5)
Only 40% of completed registered trials posted results (-8)
'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)
Regulatory history: 91
Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 38 generic makers (-1)
11 label changes approved since 2021: the safety story is still moving (-8)
Money & lawsuits: 85
Maker paid $500 million in 2002 to settle federal allegations naming this drug (Poor manufacturing practices) (-15)
Pharma paid doctors $0 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 70
Generic versions approved (38 applications)
No same-class alternatives found: little leverage to switch (-30)
Independent reviews and post-approval warnings
WHO Essential Medicine
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
What the FDA label says
Approved uses
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat Uses relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Contraindications
None listed.
Warnings and precautions
Warnings Do not use if you have ever had allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. Warnings Severe Allergy Warning : Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine . If your doctor has prescribe...
Adverse reactions (label)
Not available.
Source: FDA SPL label for Loratadine (Lannett Company, Inc.), effective 20250619.
Full label on DailyMed.
Side-effect reports sent to the FDA
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
89,305reports that mention this drug
89,212of those blame this drug, not another one the person was taking
45%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
4.1%of reports include a death, from any cause (average for all drugs: 9.1%)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
Recalls and regulatory record
2recall actions on file
9 / 38brand / generic applications
11label changes since 2021
NoREMS program
Date
Class
Firm
Reason
03/2021
Class II
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
07/2015
Class III
Ohm Laboratories, Inc.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Evidence base
189randomized trials (PubMed)
6systematic reviews
101registered trials
40%of completed trials posted results
7%terminated or withdrawn
66%industry-funded
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
Money and lawsuits
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Settlements of federal marketing and pricing allegations
2004 · Schering-Plough · $345 million Medicare fraud, kickbacks Record
2002 · Schering-Plough · $500 million Poor manufacturing practices Record
Settlements of $100M+ in which this drug (Claritin) was a named product, as recorded by the Department of Justice. A settlement resolves allegations; civil settlements are not admissions and not findings of wrongdoing. They are shown because off-label promotion cases describe how the evidence many prescribers saw was shaped.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
Who takes it and what it costs
Not in the Medicare Part D spending file (typically hospital-administered or very new drugs).
Same-class alternatives
No same-class alternatives found in RxClass.
Questions to ask your prescriber
The maker paid $500 million in 2002 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?
The most-reported problems in FDA's adverse event data are fatigue, nausea, headache. How would we recognize and handle those?
Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)