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
1Drug ineffective846
2Drug effect decreased385
3Insomnia*349
4Dizziness*195
5Somnolence*174
6Headache*163
7Nausea154
8Dyspnoea146
9Fatigue144
10Feeling abnormal123
11Dry mouth*120
12Anxiety*116
13Pain111
14Palpitations110
15Feeling jittery*103
16Chest pain86
17Diarrhoea82
18Unevaluable event81
19Heart rate increased80
20Depression*79

* 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
1Product used for unknown indication1820
2Hypersensitivity*1631
3Seasonal allergy*741
4Nasal congestion*302
5Rhinorrhoea253
6Multiple allergies*233
7Rhinitis allergic191
8Eye pruritus178
9Nasopharyngitis*134
10Sinus congestion*128

*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.

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

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.

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