Drug Safety Information for MARINOL (Dronabinol)

Safety-related Labeling Changes for MARINOL (DRONABINOL) Rx Drug: FDA Link

Safety-related Labeling Changes for SYNDROS (DRONABINOL) Rx Drug: FDA Link

Adverse Drug Reactions for MARINOL* (Dronabinol)

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 MARINOL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Nausea	281
2	Vomiting	214
3	Diarrhoea	148
4	Fatigue*	144
5	Dehydration	143
6	Death	142
7	Decreased appetite	142
8	Asthenia	132
9	Weight decreased	125
10	Dyspnoea	115
11	Pain	102
12	Abdominal pain	96
13	Pneumonia	95
14	Pyrexia	92
15	Anaemia	91
16	Headache	79
17	Drug ineffective	78
18	Confusional state	74
19	Neoplasm malignant	71
20	Convulsion	70

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	1239
2	Nausea	782
3	Decreased appetite	362
4	Increased appetite	168
5	Pain*	115
6	Appetite disorder	90
7	Hypogeusia	52
8	Muscle spasticity	52
9	Ill-defined disorder	49
10	Weight decreased	44

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

Types of Adverse Events for MARINOL

Total Reports Filed with FDA: 11862

Number of FDA Adverse Event Reports by Patient Age for MARINOL

Total Reports Filed with FDA: 11862*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dronabinol (Dronabinol, Marinol)

Charts are based on 11862 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.