Drug Safety Information for LORATADINE AND PSEUDOEPHEDRINE SULFATE (Loratadine; pseudoephedrine sulfate)
Adverse Drug Reactions for LORATADINE AND PSEUDOEPHEDRINE SULFATE* (Loratadine; pseudoephedrine sulfate)
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 AND PSEUDOEPHEDRINE SULFATE
(reported in FDA Medwatch/FAERS Reports)
|Side Effect||# of FDA Reports|
|2||Drug effect decreased||385|
|19||Heart rate increased||80|
* This side effect also appears in "Top 10 Side Effects of LORATADINE AND PSEUDOEPHEDRINE SULFATE " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking LORATADINE AND PSEUDOEPHEDRINE SULFATE
(associated with FDA Medwatch/FAERS Reports)
|Reason||# of FDA Reports|
|1||Product used for unknown indication||1820|
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for LORATADINE AND PSEUDOEPHEDRINE SULFATE
Total Reports Filed with FDA: 13428
Number of FDA Adverse Event Reports by Patient Age for LORATADINE AND PSEUDOEPHEDRINE SULFATE
Total Reports Filed with FDA: 13428*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Loratadine; pseudoephedrine sulfate (Wal itin d, Claritin-d 24 hour, Claritin-d, Allergy relief d 12, Sunmark loratadine d, Allergy relief-d, Loratadine d, Loratadine d 24 hour)
Charts are based on 13428 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.
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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.