Drug Safety Information for DELSYM (Dextromethorphan polistirex)

Adverse Drug Reactions for DELSYM* (Dextromethorphan polistirex)

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 DELSYM
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug abuse	78
2	Dizziness	72
3	Hallucination	69
4	Feeling abnormal	62
5	Overdose	56
6	Confusional state	44
7	Nausea	42
8	Vomiting	35
9	Dyspnoea	33
10	Insomnia*	32
11	Accidental overdose	30
12	Heart rate increased	30
13	Somnolence	30
14	Tremor	28
15	Cough	28
16	Euphoric mood*	27
17	Disorientation	27
18	Blood pressure increased	26
19	Drug ineffective	26
20	Anxiety	26

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

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

	Reason	# of FDA Reports
1	Cough	734
2	Product used for unknown indication	658
3	Drug abuse	85
4	Euphoric mood	43
5	Influenza like illness	41
6	Drug abuser	35
7	Influenza	31
8	Nasopharyngitis	26
9	Antitussive therapy	20
10	Bronchitis	17

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

Types of Adverse Events for DELSYM

Total Reports Filed with FDA: 2765

Number of FDA Adverse Event Reports by Patient Age for DELSYM

Total Reports Filed with FDA: 2765*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dextromethorphan polistirex (Delsym)

Charts are based on 2765 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.

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.