Drug Safety Information for CESAMET (Nabilone)

Adverse Drug Reactions for CESAMET* (Nabilone)

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 CESAMET
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Nausea	29
2	Vomiting	26
3	Headache	23
4	Asthenia	21
5	Diarrhoea	19
6	Pain*	18
7	Dyspnoea	17
8	Weight decreased	16
9	Death	14
10	Gait disturbance	14
11	Confusional state	14
12	Dizziness	14
13	Loss of consciousness	14
14	Drug interaction	12
15	Disorientation	12
16	Anxiety	11
17	Condition aggravated	11
18	Somnolence	11
19	Pneumonia	10
20	Off label use	10

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	247
2	Pain	60
3	Back pain	47
4	Insomnia	34
5	Nausea	29
6	Decreased appetite	29
7	Migraine	25
8	Inflammation	12
9	Antiemetic supportive care	12
10	Crohn's disease	11

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

Types of Adverse Events for CESAMET

Total Reports Filed with FDA: 1307

Number of FDA Adverse Event Reports by Patient Age for CESAMET

Total Reports Filed with FDA: 1307*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nabilone (Cesamet)

Charts are based on 1307 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.