Drug Safety Information for ULTANE (Sevoflurane)

Safety-related Labeling Changes for ULTANE (SEVOFLURANE) Rx Drug: FDA Link

Adverse Drug Reactions for ULTANE* (Sevoflurane)

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 ULTANE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Cardiac arrest	201
2	Hypotension	180
3	Bradycardia	176
4	Anaesthetic complication	145
5	Drug interaction	140
6	Post procedural complication	140
7	Blood pressure decreased	127
8	Tachycardia	122
9	Ventricular fibrillation	105
10	Hyperthermia malignant	104
11	Oxygen saturation decreased	99
12	Apnoea	98
13	Ventricular tachycardia	96
14	Anaphylactic shock	87
15	Rhabdomyolysis	87
16	Pulmonary oedema	84
17	Anaphylactic reaction	79
18	Nausea	75
19	Procedural complication	75
20	Renal failure	69

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

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

	Reason	# of FDA Reports
1	Anaesthesia	1814
2	Maintenance of anaesthesia	1274
3	General anaesthesia	1183
4	Product used for unknown indication	695
5	Induction of anaesthesia	689
6	Induction and maintenance of anaesthesia	241
7	Anaesthesia procedure	109
8	Maternal exposure during pregnancy	85
9	Surgery	74
10	Wheezing	34

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

Types of Adverse Events for ULTANE

Total Reports Filed with FDA: 10628

Number of FDA Adverse Event Reports by Patient Age for ULTANE

Total Reports Filed with FDA: 10628*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sevoflurane (Sevoflurane, Ultane, Sojourn)

Charts are based on 10628 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.