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
1Cardiac arrest201
2Hypotension180
3Bradycardia176
4Anaesthetic complication145
5Drug interaction140
6Post procedural complication140
7Blood pressure decreased127
8Tachycardia122
9Ventricular fibrillation105
10Hyperthermia malignant104
11Oxygen saturation decreased99
12Apnoea98
13Ventricular tachycardia96
14Anaphylactic shock87
15Rhabdomyolysis87
16Pulmonary oedema84
17Anaphylactic reaction79
18Nausea75
19Procedural complication75
20Renal failure69

* 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
1Anaesthesia1814
2Maintenance of anaesthesia1274
3General anaesthesia1183
4Product used for unknown indication695
5Induction of anaesthesia689
6Induction and maintenance of anaesthesia241
7Anaesthesia procedure109
8Maternal exposure during pregnancy85
9Surgery74
10Wheezing34

*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.

Click to go back to search results and ULTANE Reviews and Review Summary .

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.

Visit   DrugInformer.com more on ULTANE's side effects.