Drug Safety Information for INAPSINE (Droperidol)

Adverse Drug Reactions for INAPSINE* (Droperidol)

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 INAPSINE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Renal failure acute	77
2	Pain	52
3	Nausea	49
4	Hypotension	44
5	Anxiety*	44
6	Dyspnoea	43
7	Vomiting	38
8	Haematuria	38
9	Death	37
10	Oliguria	33
11	Tachycardia	32
12	Pyrexia	28
13	Depression	27
14	Toxicity to various agents	27
15	Drug interaction	26
16	Cardiac arrest	26
17	Drug hypersensitivity	25
18	Overdose	24
19	Hyperhidrosis	24
20	Bradycardia	23

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	618
2	Nausea*	168
3	Anaesthesia	78
4	Ill-defined disorder	59
5	Pain	57
6	Prophylaxis of nausea and vomiting	53
7	Vomiting	50
8	General anaesthesia	49
9	Sedation*	47
10	Migraine*	38

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

Types of Adverse Events for INAPSINE

Total Reports Filed with FDA: 4880

Number of FDA Adverse Event Reports by Patient Age for INAPSINE

Total Reports Filed with FDA: 4880*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Droperidol (Droleptan, Dehydrobenzperidol, Inapsine, Droperidol)

Charts are based on 4880 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.