If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.
Endone Side Effects Reported to FDA
Endone Side Effect Report#5359250-2 Abnormal Sleep-related Event, Amnesia, Blood Alcohol Increased, Fall, Head Injury, Sleep Walking
This is a report of a 48-year-old male patient (weight: NA) from Australia, suffering from the following health symptoms/conditions: NA, who was treated with Endone (dosage: NA, start time:
Apr 15, 2006), combined with:
Dormizol (10 Mg)
and developed a serious reaction and side effect(s): Abnormal Sleep-related Event, Amnesia, Blood Alcohol Increased, Fall, Head Injury, Sleep Walking after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Endone treatment in male patients, resulting in Abnormal Sleep-related Event side effect. The patient was hospitalized.
Endone Side Effect Report#5321689-9 Abnormal Sleep-related Event, Amnesia, Blood Alcohol Increased, Fall, Head Injury, Sleep Walking
This report suggests a potential EndoneAbnormal Sleep-related Event side effect(s) that can have serious consequences. A 48-year-old male patient (weight: NA) from Australia was diagnosed with the following symptoms/conditions: NA and used Endone (dosage: NA) starting
Apr 15, 2006. After starting Endone the patient began experiencing various side effects, including: Abnormal Sleep-related Event, Amnesia, Blood Alcohol Increased, Fall, Head Injury, Sleep WalkingAdditional drugs used concurrently:
Dormizol (10 Mg)
The patient was hospitalized. Although Endone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abnormal Sleep-related Event, may still occur.
Endone Side Effect Report#4596534-X Coordination Abnormal, Labyrinthitis
This Coordination Abnormal problem was reported by a pharmacist from . A 26-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 1999 this consumer started treatment with Endone (dosage: NA). The following drugs were being taken at the same time:
Noten (50 Mg, Bid)
Nifedipine (50 Mg, Qd)
When using Endone, the patient experienced the following unwanted symptoms/side effects: Coordination Abnormal, LabyrinthitisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Coordination Abnormal, may become evident only after a product is in use by the general population.
The appearance of Endone on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.
Why Your Notes are Important
Your notes could be helpful in several ways:
You can use them to remind you of details that may alert your health care professional(s) to a problem
You will have a record to refer to in the future, in case you are ever prescribed the same medicine again
You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.
Medicine Name and Dosage:
Date & Time
Other Medicine(s) or Treatment(s)
Scale: 1 = very mild to 10 = very bad
Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Endone reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.