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Hypnovel Side Effects

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Common Hypnovel Side Effects


The most commonly reported Hypnovel side effects (click to view or check a box to report):

Anaphylactic Shock (2)
Bradyphrenia (1)
Bladder Cancer (1)
Agitation (1)
Weight Increased (1)
Capillary Leak Syndrome (1)
Extravasation (1)
Tachycardia (1)
Small Intestinal Perforation (1)
Hepatotoxicity (1)
Hepatitis Acute (1)
Disseminated Intravascular Coagulation (1)


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.

Hypnovel Side Effects Reported to FDA



Hypnovel Side Effect Report#7487705-3
Hepatitis Acute, Hepatotoxicity
This is a report of a 67-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Hypnovel (midazolam Hcl) (no Pref. Name) (dosage: 2 Mg; Iv, start time:
Jan 07, 2011), combined with:
  • Sevoflurane (Inh)
  • Solu-medrol (120 Mg; Iv)
  • Effexor
  • Sufenta (sufentanil Citrate) (20 Mg; Iv)
  • Diprivan (260 Mg; Iv)
  • Acetaminophen (1 Gm;iv)
  • Ketalar (30 Mg; Iv)
  • Prazepam
and developed a serious reaction and side effect(s): Hepatitis Acute, Hepatotoxicity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hypnovel (midazolam Hcl) (no Pref. Name) treatment in female patients, resulting in Hepatitis Acute side effect. The patient was hospitalized.
Hypnovel Side Effect Report#7377273-9
Bradyphrenia
This report suggests a potential Hypnovel Bradyphrenia side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from New Zealand was diagnosed with the following symptoms/conditions: NA and used Hypnovel (dosage: NA) starting NS. After starting Hypnovel the patient began experiencing various side effects, including: BradyphreniaAdditional drugs used concurrently:
  • Topamax
  • Ferrous Sulfate Tab
  • Zinc
Although Hypnovel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bradyphrenia, may still occur.
Hypnovel Side Effect Report#7289112-5
Small Intestinal Perforation, Anaphylactic Shock
This Small Intestinal Perforation problem was reported by a physician from France. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 24, 2010 this consumer started treatment with Hypnovel (dosage: NA). The following drugs were being taken at the same time:
  • Succinylcholine Chloride
  • Hypnomidate
  • Diprivan
When using Hypnovel, the patient experienced the following unwanted symptoms/side effects: Small Intestinal Perforation, Anaphylactic ShockAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Small Intestinal Perforation, may become evident only after a product is in use by the general population.
Hypnovel Side Effect Report#5565335-8
Agitation, Bladder Cancer
This Agitation side effect was reported by a physician from France. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: agitation.The patient was prescribed Hypnovel (inj) (drug dosage: Indication: Anxiety, Form Reported As Injectable-solution.), which was initiated on NS. Concurrently used drugs: NA..After starting to take Hypnovel (inj) the consumer reported adverse symptoms, such as: Agitation, Bladder CancerThese side effects may potentially be related to Hypnovel (inj).
Hypnovel Side Effect Report#5042909-4
Anaphylactic Shock, Capillary Leak Syndrome, Disseminated Intravascular Coagulation, Extravasation, Tachycardia, Weight Increased
This is a report of a 63-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: anaesthesia, who was treated with Hypnovel (dosage: NA, start time:
Jun 08, 2001), combined with:
  • Augmentin '125'
  • Augmentin '125'
  • Augmentin '125'
  • Norcuron
  • Fentanyl Citrate
and developed a serious reaction and side effect(s): Anaphylactic Shock, Capillary Leak Syndrome, Disseminated Intravascular Coagulation, Extravasation, Tachycardia, Weight Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hypnovel treatment in female patients, resulting in Anaphylactic Shock side effect.



The appearance of Hypnovel 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.

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What are common Hypnovel Side Effects for Men?

Men Side EffectsReports
Agitation 1
Bladder Cancer 1

Track Your Side Effects

Note Your Observations

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

  • Log Form

    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:
    Side Effects Scale 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.

    Hypnovel 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.

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    Discuss Hypnovel Side Effects

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    Hypnovel Safety Alerts, Active Ingredients, Usage Information

    More About Hypnovel

    Side Effects reported to FDA: 5

    Hypnovel safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 1

    Latest Hypnovel clinical trials