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Dormicum Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Interstitial Lung Disease, Pulmonary Alveolar Haemorrhage (7871214-3)
on Oct 17, 2011 Male from JAPAN , 77 years of age, weighting 123.5 lb, was treated with Dormicum (midazolam)injection. Directly after, patient experienced the unwanted or unexpected Dormicum side effects: interstitial lung disease, pulmonary alveolar haemorrhage. Dormicum (midazolam)injection dosage: N/A.
Associated medications used:
  • 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 (7750454-8)
Patient was taking Dormicum (nitrazepam) (injection). Patient felt the following Dormicum side effects: 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 on Aug 28, 2011 from JAPAN Additional patient health information: Female , 15 years of age, weighting 92.59 lb, was diagnosed with
  • vomiting
and. Dormicum (nitrazepam) (injection) dosage: 150 Mg Milligram(s), Intravenous, 100 Mg Milligram(s), Intravenous. Patient was hospitalized and became disabled.

Brain Herniation, Intracranial Pressure Increased (7270883-9)
Adverse event was reported on Jan 24, 2011 by a Patient taking Dormicum (Dosage: Drip Infusion) was diagnosed with
  • sedation
  • renal failure
  • infection
  • gastrointestinal haemorrhage
  • asthma
and. Location: JAPAN , child 1 years of age, weighting 22.05 lb, After Dormicum was administered, patient encountered several Dormicum side effects: brain herniation, intracranial pressure increased.
Multiple concurrent drugs taken:
  • Lasix (Drip Infusion)
  • Meropenem
  • Omepral
  • Sevoflurane (4-5% Daily)
  • Predonine
  • Inovan (3-9 Mcg/kg/min Drip Infusion)
  • Hanp (Drip Infusion)
  • Dobutrex (Drip Infusion)


Coma, Convulsion, Metastatic Neoplasm (7065091-0)
on Oct 18, 1990 Female from GERMANY , 60 years of age, was treated with Dormicum (inj). Directly after, patient experienced the unwanted or unexpected Dormicum side effects: coma, convulsion, metastatic neoplasm. Dormicum (inj) dosage: N/A. Patient was hospitalized.


Clonic Convulsion (7064847-8)
on Jul 22, 1987 Male from GERMANY , weighting 2.43 lb, was treated with Dormicum (inj). Patient felt the following Dormicum side effects: clonic convulsion. Dormicum (inj) dosage: N/A.

Acute Respiratory Distress Syndrome, Altered State Of Consciousness (6822196-4)
Patient was taking Dormicum (midazolam) Injection, 10 Mg. After Dormicum was administered, patient encountered several Dormicum side effects: acute respiratory distress syndrome, altered state of consciousness on Jun 25, 2010 from JAPAN Additional patient health information: Female , 80 years of age, weighting 84.66 lb, was diagnosed with
  • acute respiratory distress syndrome
  • pneumonia
and. Dormicum (midazolam) Injection, 10 Mg dosage: Mg, Continuous,iv Drip.
Multiple concurrent drugs taken:
  • 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)


Acute Respiratory Distress Syndrome, Altered State Of Consciousness, Cardiac Failure, Delayed Recovery From Anaesthesia, Pneumonia (6816821-1)
Adverse event was reported on Jun 21, 2010 by a Female taking Dormicum (midazolam) Injection, 10mg (Dosage: Continuous, Iv Drip) was diagnosed with
  • acute respiratory distress syndrome
  • disseminated intravascular coagulation
  • pneumonia
and. Location: JAPAN , 80 years of age, weighting 84.66 lb, Directly after, patient experienced the unwanted or unexpected Dormicum side effects: acute respiratory distress syndrome, altered state of consciousness, cardiac failure, delayed recovery from anaesthesia, pneumonia.

Liver Disorder (6428885-8)
on Oct 28, 2009 Female from JAPAN , 82 years of age, was treated with Dormicum (inj). Patient felt the following Dormicum side effects: liver disorder. Dormicum (inj) dosage: N/A.
Multiple prescriptions taken:
  • Ampicillin Sodium
  • Ampicillin Sodium/sulbactam Sodium
Patient was hospitalized.

Pancreatic Carcinoma (5567060-6)
on Nov 25, 2004 Male from NETHERLANDS , 53 years of age, was diagnosed with
  • palliative care
and was treated with Dormicum (inj). After Dormicum was administered, patient encountered several Dormicum side effects: pancreatic carcinoma. Dormicum (inj) dosage: N/A.

Colitis Ischaemic, Diarrhoea Haemorrhagic, Gastrointestinal Erosion, Haemorrhoids, Large Intestinal Ulcer, Oedema Mucosal, Polyp, Rectal Haemorrhage (5151068-9)
Patient was taking Dormicum. Directly after, patient experienced the unwanted or unexpected Dormicum side effects: colitis ischaemic, diarrhoea haemorrhagic, gastrointestinal erosion, haemorrhoids, large intestinal ulcer, oedema mucosal, polyp, rectal haemorrhage on Sep 18, 2006 from TURKEY Additional patient health information: Female , 65 years of age, was diagnosed with
  • colonoscopy
  • irritable bowel syndrome
  • diabetes mellitus non-insulin-dependent
and. Dormicum dosage: 4 Mg/day.
Associated medications used:
  • 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)
Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Dormicum Information

More About Dormicum

Side Effects reported to FDA: 10. View Dormicum Adverse Reports

Dormicum safety alerts: No

Reported deaths: 3

Reported hospitalizations: 2

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