Drug Safety Information for LORATADINE (Loratadine)

Adverse Drug Reactions for LORATADINE* (Loratadine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with LORATADINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective4370
2Nausea1651
3Dyspnoea1483
4Headache*1432
5Overdose1399
6Fatigue*1325
7Dizziness*1296
8Pain1225
9Diarrhoea1045
10Drug effect decreased1013
11Vomiting963
12Rash914
13Anxiety*851
14Somnolence*804
15Depression*788
16Insomnia*785
17Asthenia771
18Off label use760
19Cough745
20Chest pain742

* This side effect also appears in "Top 10 Side Effects of LORATADINE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking LORATADINE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication15085
2Hypersensitivity*12417
3Seasonal allergy*5132
4Multiple allergies3018
5Premedication1568
6Rhinitis allergic1356
7Rhinorrhoea*1294
8Pruritus800
9Eye pruritus591
10Sinus disorder536

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for LORATADINE

Total Reports Filed with FDA: 130167


Number of FDA Adverse Event Reports by Patient Age for LORATADINE

Total Reports Filed with FDA: 130167*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Loratadine (Wal itin, Wal-itin, Allegy relief, Bactimicina allergy, Leader loratadine, Medique loradamed, Sunmark loratadine, Children's claritin, Childrens wal-itin, Childrens loratadine, Childrens non-drowsy, Loratadine odt, Clarium, Alavert allergy, Loratadine redidose, Loratadine od, Alavert d, Claritin reditabs, Alavert, Loratadine, Claritin)

Charts are based on 130167 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and LORATADINE Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.