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Dormicum Side Effects

Common Dormicum Side Effects


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

Acute Respiratory Distress Syndrome (2)
Renal Failure (2)
Altered State Of Consciousness (2)
Tachycardia Foetal (1)
Polyp (1)
Somnolence (1)
Respiratory Failure (1)
Rectal Haemorrhage (1)
Respiration Abnormal (1)
Pneumonia (1)
Sedation (1)
Liver Disorder (1)
Neonatal Respiratory Depression (1)
Oedema Mucosal (1)
Pancreatic Carcinoma (1)
Multi-organ Failure (1)
Metastatic Neoplasm (1)
Large Intestinal Ulcer (1)
Low Birth Weight Baby (1)
Intracranial Pressure Increased (1)

➢ More



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.

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.

Dormicum Side Effects Reported to FDA

The following Dormicum 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.


The appearance of Dormicum 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.
Hypertensive Crisis
This is a report of a 65-year-old female patient (weight: NA) from DE, suffering from the following symptoms/conditions: NA, who was treated with Dormicum (oral) (dosage: NA, start time: NS), combined with:
  • Valium
and developed a serious reaction and side effect(s). The consumer presented with:
  • Hypertensive Crisis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dormicum (oral) treatment in female patients, resulting in hypertensive crisis side effect.

Hepatic Failure, Renal Failure, Pyrexia, Somnolence
This report suggests a potential Dormicum (inj) Hepatic Failure, Renal Failure, Pyrexia, Somnolence side effect(s) that can have serious consequences. A 7-year-old female patient (weight: NA) from GR was diagnosed with the following symptoms/conditions: NA and used Dormicum (inj) (dosage: 5mg Administered (date/time Not Specified)) starting NS. Soon after starting Dormicum (inj) the patient began experiencing various side effects, including:
  • Hepatic Failure
  • Renal Failure
  • Pyrexia
  • Somnolence
Drugs used concurrently:
  • Anexate (3 Cc Administered (date/time) Not Specified)
  • Dotarem (germany)
  • Propofol (5cc Administered (date/time Not Specified))
The patient was hospitalized. Although Dormicum (inj) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hepatic failure, may still occur.

Sedation
This Sedation problem was reported by a pharmacist from JP. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: sedation,reversal of sedation. On NS this consumer started treatment with Dormicum (inj) (dosage: (30 Tubefuls) For Sedation (duration: About 2 To 3 Weeks).). The following drugs were being taken at the same time:
  • Anexate
When commencing Dormicum (inj), the patient experienced the following unwanted symptoms/side effects:
  • Sedation
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as sedation, may become evident only after a product is in use by the general population.

Neonatal Respiratory Depression, Apgar Score Low, Exposure During Breast Feeding, Tachycardia Foetal, Caesarean Section, Low Birth Weight Baby
This is a report of a male patient (weight: NA) from COUNTRY NOT SPECIFIED. The patient developed the following symptoms/conditions: foetal exposure during pregnancy and was treated with Dormicum (inj) (dosage: Regimen:1) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Neonatal Respiratory Depression
  • Apgar Score Low
  • Exposure During Breast Feeding
  • Tachycardia Foetal
  • Caesarean Section
  • Low Birth Weight Baby
This opens a possibility that Dormicum (inj) treatment could cause the above reactions, including neonatal respiratory depression, and some male subjects may be more susceptible.


Respiration Abnormal
A 6-year-old female patient (weight: NA) from COUNTRY NOT SPECIFIED with the following symptoms/conditions: sedation,maintenance of anaesthesia started Dormicum treatment (dosage: NA) on NS. Soon after starting Dormicum treatment, the subject experienced various side effects, including:
  • Respiration Abnormal
Concurrently used drugs:
  • Propofol (10 Ml Per Hour)
  • Nitrous Oxide
This finding indicates that some female patients could be more vulnerable to Dormicum.

Interstitial Lung Disease, Pulmonary Alveolar Haemorrhage
A 77-year-old male patient from JAPAN (weight: NA) experienced symptoms, such as: NA and was treated with Dormicum (midazolam)injection(dosage: NA). The treatment was initiated on Aug 10, 2011. After that a consumer reported the following side effect(s):
  • Interstitial Lung Disease
  • Pulmonary Alveolar Haemorrhage
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Dormicum (midazolam)injection efficacy:
  • Plavix (75 Mg Milligram(s), Qd, Oral)
  • Aspirin
  • Concentrated Red Cells (concentrated Human Red Blood Cells)
  • Samsca (15 Mg Milligram(s), Qd, Oral)
  • Finibax (doripenem)injection (0.25 G Gram(s), Tid, Intravenous)
  • Lasix
  • Trichlormethiazide


Bacterial Infection, Multi-organ Failure, Quality Of Life Decreased, Continuous Haemodiafiltration, Renal Failure, Depressed Level Of Consciousness, Respiratory Failure, Activities Of Daily Living Impaired, Bone Marrow Failure
In this report, Dormicum (nitrazepam) (injection) was administered for the following condition: vomiting.A 15-year-old female consumer from JAPAN (weight: NA) started Dormicum (nitrazepam) (injection) treatment (dosage: 150 Mg Milligram(s), Intravenous, 100 Mg Milligram(s), Intravenous) on Nov 09, 2009.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Bacterial Infection
  • Multi-organ Failure
  • Quality Of Life Decreased
  • Continuous Haemodiafiltration
  • Renal Failure
  • Depressed Level Of Consciousness
  • Respiratory Failure
  • Activities Of Daily Living Impaired
  • Bone Marrow Failure
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized and became disabled.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Dormicum (nitrazepam) (injection) treatment could be related to the listed above side effect(s).

Brain Herniation, Intracranial Pressure Increased
This is a report of the following Dormicum side effect(s):
  • Brain Herniation
  • Intracranial Pressure Increased
A 1-year-old patient from JAPAN (weight: NA) presented with the following condition: sedation,renal failure,infection,gastrointestinal haemorrhage,asthma and received a treatment with Dormicum (dosage: Drip Infusion) starting: Dec 04, 2009.The following concurrently used drugs could have generated interactions:
  • Lasix (Drip Infusion)
  • Meropenem
  • Omepral
  • Sevoflurane (4-5% Daily)
  • Predonine
  • Inovan (3-9 Mcg/kg/min Drip Infusion)
  • Hanp (Drip Infusion)
  • Dobutrex (Drip Infusion)
This report suggests that a Dormicum treatment could be associated with the listed above side effect(s).

Coma, Convulsion, Metastatic Neoplasm
This Dormicum (inj) report was submitted by a 60-year-old female consumer from GERMANY (weight: NA). The patient was diagnosed with: NA and Dormicum (inj) was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Coma
  • Convulsion
  • Metastatic Neoplasm
Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Dormicum (inj) treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Clonic Convulsion
This is a report of a possible correlation between Dormicum (inj) use and the following symptoms/side effect(s):
  • Clonic Convulsion
which could contribute to an assessment of Dormicum (inj) risk profile.A male consumer from GERMANY (weight: NA) was suffering from NA and was treated with Dormicum (inj) (dosage: NA) starting Apr 13, 1987.Other concurrent medications: NA.

Acute Respiratory Distress Syndrome, Altered State Of Consciousness
A 80-year-old female patient from JAPAN (weight: NA) presented with the following symptoms: acute respiratory distress syndrome,pneumonia and after a treatment with Dormicum (midazolam) Injection, 10 Mg (dosage: Mg, Continuous,iv Drip) experienced the following side effect(s):
  • Acute Respiratory Distress Syndrome
  • Altered State Of Consciousness
The treatment was started on Jan 06, 2010. Dormicum (midazolam) Injection, 10 Mg was used in combination with the following drugs:
  • Funguard (micafungin) Injection (150 Mg, Uid/qd, Iv Drip)
  • Meropenem (0.5 G, Tid, Iv Drip)
  • Clindamycin (600 Mg, Tid, Iv Drip)
  • Elaspol (sivelestat Sodium) Injection (200 Mg, Continuous, Iv Drip)
  • Dopamine Hydrochloride (Iv Drip)
  • Lasix (20 Mg, Bid, Iv Nos)
  • Soldactone (potassium Canrenoate) Injection (100 Mg, Uid/qd, Iv Nos)
  • Solu-medrol (250 Mg, Bid, Iv Drip)
This report could alert potential Dormicum (midazolam) Injection, 10 Mg consumers.

Acute Respiratory Distress Syndrome, Altered State Of Consciousness, Cardiac Failure, Delayed Recovery From Anaesthesia, Pneumonia
In this report, a 80-year-old female patient from JAPAN (weight: NA) was affected by a possible Dormicum (midazolam) Injection, 10mg side effect.The patient was diagnosed with acute respiratory distress syndrome,disseminated intravascular coagulation,pneumonia. After a treatment with Dormicum (midazolam) Injection, 10mg (dosage: Continuous, Iv Drip, start date: Jan 06, 2010), the patient experienced the following side effect(s):
  • Acute Respiratory Distress Syndrome
  • Altered State Of Consciousness
  • Cardiac Failure
  • Delayed Recovery From Anaesthesia
  • Pneumonia
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Dormicum (midazolam) Injection, 10mg treatment.

Liver Disorder
This is a report of a 82-year-old female patient from JAPAN (weight: NA), who used Dormicum (inj) (dosage: NA) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Liver Disorder
The following drugs could possibly have interacted with the Dormicum (inj) treatment
  • Ampicillin Sodium
  • Ampicillin Sodium/sulbactam Sodium
The patient was hospitalized.Taken together, these observations suggest that a Dormicum (inj) treatment could be related to side effect(s), such as Liver Disorder.

Pancreatic Carcinoma
This pancreatic carcinoma side effect was reported by a physician from NETHERLANDS. A 53-year-old male patient (weight:NA) experienced the following symptoms/conditions: palliative care. The patient was prescribed Dormicum (inj) (dosage: NA), which was started on NS. Concurrently used drugs: NA. When starting to take Dormicum (inj) the consumer reported the following symptoms:
  • Pancreatic Carcinoma
These side effects may potentially be related to Dormicum (inj).

Colitis Ischaemic, Diarrhoea Haemorrhagic, Gastrointestinal Erosion, Haemorrhoids, Large Intestinal Ulcer, Oedema Mucosal, Polyp, Rectal Haemorrhage
This is a Dormicum side effect report of a 65-year-old female patient (weight:NA) from TURKEY, suffering from the following symptoms/conditions: colonoscopy,irritable bowel syndrome,diabetes mellitus non-insulin-dependent, who was treated with Dormicum (dosage:4 Mg/day, start time: Sep 13, 2006), combined with:
  • Zelmac (6 Mg, Bid)
  • Insulin
  • Delix (2.5 Mg, Qd)
  • Beloc Zok (50 Mg, Qd)
  • Pravachol (10 Mg, Qd)
  • Metformin Hydrochloride (Unk, Qd)
  • Lansor (30 Mg, Bid)
, and developed a serious reaction and a colitis ischaemic side effect. The patient presented with:
  • Colitis Ischaemic
  • Diarrhoea Haemorrhagic
  • Gastrointestinal Erosion
  • Haemorrhoids
  • Large Intestinal Ulcer
  • Oedema Mucosal
  • Polyp
  • Rectal Haemorrhage
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Dormicum treatment in female patients suffering from colonoscopy,irritable bowel syndrome,diabetes mellitus non-insulin-dependent, resulting in colitis ischaemic.

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


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