Drug Safety Information for UNISOM (Doxylamine succinate)

FDA Safety-related Labeling Changes for UNISOM (DOXYLAMINE SUCCINATE) Over-the-counter Drug: Safety Information Link

FDA Safety-related Labeling Changes for DICLEGIS (DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for UNISOM* (Doxylamine succinate)

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 UNISOM
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Toxicity to various agents	138
2	Drug abuse	106
3	Completed suicide	99
4	Overdose	89
5	Somnolence*	51
6	Death	50
7	Insomnia*	50
8	Intentional drug misuse	47
9	Drug ineffective	39
10	Intentional overdose	39
11	Vomiting	37
12	Cardiac arrest	37
13	Incorrect dose administered	37
14	Dizziness	33
15	Suicide attempt	33
16	Fatigue*	32
17	Nausea	32
18	Respiratory arrest	31
19	Feeling abnormal	28
20	Cardio-respiratory arrest	28

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	479
2	Insomnia*	407
3	Sleep disorder	239
4	Sleep disorder therapy	111
5	Suicide attempt	83
6	Intentional overdose	63
7	Nausea	34
8	Overdose	28
9	Depression	23
10	Completed suicide	23

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

Types of Adverse Events for UNISOM

Total Reports Filed with FDA: 3506

Number of FDA Adverse Event Reports by Patient Age for UNISOM

Total Reports Filed with FDA: 3506*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Doxylamine succinate (Doxy-sleep-aid, Aldex an, Care one sleep aid, Equaline sleep aid, Good sense sleep aid, Leader sleep aid, Nighttime sleepaid, Sunmark sleep aid, Wal som, Unisom, Decapryn, Unisom sleeptabs, Equate sleep aid, Doxylamine succinate)

Charts are based on 3506 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.