Drug Safety Information for SEMPREX-D (Acrivastine; pseudoephedrine hydrochloride)

Safety-related Labeling Changes for SEMPREX-D (ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for SEMPREX-D* (Acrivastine; pseudoephedrine hydrochloride)

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 SEMPREX-D
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fall13
2Dizziness12
3Hallucination11
4Muscle contractions involuntary11
5Dyspnoea10
6Akathisia10
7Eating disorder10
8Chest pain10
9Asthenia9
10Depression8
11Nausea7
12Acquired epidermolysis bullosa6
13Fatigue6
14Insomnia*6
15Hypersensitivity6
16Pruritus6
17Migraine5
18Oedema peripheral5
19Rash erythematous5
20Arthritis5

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

Top 10 Reasons for Taking SEMPREX-D
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hypersensitivity86
2Product used for unknown indication68
3Sinusitis31
4Seasonal allergy*28
5Multiple allergies9
6Nasopharyngitis6
7Upper respiratory tract infection5
8Eczema5
9Premedication3
10Rhinitis allergic2

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


Types of Adverse Events for SEMPREX-D

Total Reports Filed with FDA: 618


Number of FDA Adverse Event Reports by Patient Age for SEMPREX-D

Total Reports Filed with FDA: 618*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Acrivastine; pseudoephedrine hydrochloride (Semprex, Semprex-d)

Charts are based on 618 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 SEMPREX-D 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.