Drug Safety Information for AMIDATE (Etomidate)

FDA Safety-related Labeling Changes for AMIDATE (ETOMIDATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for AMIDATE* (Etomidate)

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 AMIDATE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Renal failure	219
2	Pain	200
3	Injury	190
4	Unevaluable event	174
5	Anxiety	172
6	Fear	157
7	Emotional distress	145
8	Renal injury	138
9	Renal impairment	123
10	Stress	117
11	Multi-organ failure	116
12	Anhedonia	116
13	Death	110
14	Renal failure acute	75
15	Hypotension	74
16	Depression	73
17	Cardiac arrest	53
18	Bradycardia	47
19	Cerebrovascular accident	44
20	Drug interaction	42

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	733
2	Anaesthesia	375
3	Induction of anaesthesia*	288
4	Endotracheal intubation	91
5	General anaesthesia	76
6	Sedation	60
7	Sedative therapy	29
8	Wada test	16
9	Electroconvulsive therapy	13
10	Subarachnoid haemorrhage	8

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

Types of Adverse Events for AMIDATE

Total Reports Filed with FDA: 5802

Number of FDA Adverse Event Reports by Patient Age for AMIDATE

Total Reports Filed with FDA: 5802*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Etomidate (Hypnomidate, Amidate, Etomidate)

Charts are based on 5802 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.