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FDA Adverse Reports: 26. View All

Midazolam FDA safety alerts: 2002

Reported deaths: 13

Reported hospitalizations: 57

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Often additional risks of using a medication, such as Midazolam, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Midazolam users, Learn more about unwanted side effects & find ways to reduce them. Browse Midazolam Adverse Reports reported to FDA and participate in Midazolam discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Midazolam. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Midazolam Adverse Effect Reports (FDA)

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6590771-0 | Complex Regional Pain Syndrome, Depressed Level Of Consciousness, Dissociative Disorder, Procedural Nausea, Procedural Vomiting
on Feb 15, 2010 Female patient from , 52 years of age, weighting 108.0 lb, was treated with Midazolam (View Usage). Patient experienced the following unwanted or unexpected effects: complex regional pain syndrome (What is complex regional pain syndrome?), depressed level of consciousness, dissociative disorder, procedural nausea, procedural vomiting. Midazolam dosage: 2 Mg. During the same period patient was treated with PROPOFOL (100 Mg) (View Propofol Review and Propofol Label ), FENTANYL 100 (100 Mcg) (View Fentanyl-100 Review and Fentanyl-100 Label ), FENTANYL 100 (160 Mcg) (View Fentanyl-100 Review and Fentanyl-100 Label ). Patient was hospitalized.

5135899-7 | Unresponsive To Stimuli
Patient was taking Midazolam (View Usage). Patient had the following side effects: unresponsive to stimuli on Oct 10, 2006 from UNITED STATES Additional patient health information: Female patient , 84 years of age, weighting 127.0 lb, was diagnosed with sedation and. Midazolam dosage: 1 Mg;once;iv. During the same period patient was treated with FUROSEMIDE (View Furosemide Review and Furosemide Label ), NITROGLYCERIN (View Nitroglycerin Review and Nitroglycerin Label ).

5019620-9 | Blood Pressure Increased, Headache, Hyperhidrosis, Tachycardia
Adverse event was reported on May 19, 2006 by a Female patient taking Midazolam (View Usage) (Dosage: 2 Mg; Once; Iv) was diagnosed with sedation and. Location: UNITED STATES , 43 years of age, After Midazolam was administered, patient had the following side effects: blood pressure increased, headache (What is headache?), hyperhidrosis, tachycardia.

4886142-5 | Blood Pressure Decreased, Loss Of Consciousness, Oxygen Saturation Decreased
on Jan 18, 2006 Female patient from UNITED STATES , 86 years of age, weighting 222.7 lb, was diagnosed with sedation and was treated with Midazolam (View Usage). Patient experienced the following unwanted or unexpected effects: blood pressure decreased, loss of consciousness, oxygen saturation decreased. Midazolam dosage: 2 Mg 1v X 1. During the same period patient was treated with DILTIAZEM HCL (View Diltiazem Hcl Review and Diltiazem Hcl Label ), ADVAIR DISKUS 100/50 (View Advair Diskus 100/50 Review and Advair Diskus 100/50 Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), COMBIVENT (View Combivent Review and Combivent Label ), IRON (View Iron Review and Iron Label ), GABAPENTIN (View Gabapentin Review and Gabapentin Label ), LEVOTHYROXINE SODIUM (View Levothyroxine Sodium Review and Levothyroxine Sodium Label ), LISINOPRIL (View Lisinopril Review and Lisinopril Label ).


4872047-2 | Angioneurotic Oedema, Disseminated Intravascular Coagulation
on Dec 19, 2005 Male patient from UNITED KINGDOM , weighting 176.4 lb, was diagnosed with sedation, infection prophylaxis and was treated with Midazolam (View Usage). Patient had the following side effects: angioneurotic oedema, disseminated intravascular coagulation. Midazolam dosage: 4 Mg Iv. During the same period patient was treated with GENTAMICIN (240 Mg) (View Gentamicin Review and Gentamicin Label ), AMPICILLIN SODIUM (1 G Freq) (View Ampicillin Sodium Review and Ampicillin Sodium Label ), GLYCINE HCL (View Glycine Hcl Review and Glycine Hcl Label ), MARCAINE /00330101/ (310 Mg Iv) (View Marcaine /00330101/ Review and Marcaine /00330101/ Label ), ATENOLOL (View Atenolol Review and Atenolol Label ), PERINDOPRIL (View Perindopril Review and Perindopril Label ). Patient was hospitalized.

4804881-9 | Blood Creatine Phosphokinase Increased, Convulsion, Hyperthermia, Hypotension, Hypothermia
Patient was taking Midazolam (View Usage). After Midazolam was administered, patient had the following side effects: blood creatine phosphokinase increased, convulsion, hyperthermia, hypotension, hypothermia (What is hypothermia?) on Sep 30, 2005 from UNITED STATES Additional patient health information: Male patient , 29 years of age, . Midazolam dosage: . During the same period patient was treated with PHENOBARBITAL TAB (View Phenobarbital Tab Review and Phenobarbital Tab Label ), PHENYTOIN (View Phenytoin Review and Phenytoin Label ).

4804855-8 | Exposure To Toxic Agent, Respiratory Fume Inhalation Disorder
Adverse event was reported on Sep 30, 2005 by a Female patient taking Midazolam (View Usage) (Dosage: ) . Location: UNITED STATES , child 4 years of age, Patient experienced the following unwanted or unexpected effects: exposure to toxic agent, respiratory fume inhalation disorder. During the same period patient was treated with CARBON MONOXIDE (View Carbon Monoxide Review and Carbon Monoxide Label ).

4788448-7 | Bone Marrow Failure, Dyspnoea Exacerbated, Hepatic Failure, Pneumonia
on Sep 21, 2005 Female patient from JAPAN , 54 years of age, was diagnosed with sedation, acute lymphocytic leukaemia and was treated with Midazolam (View Usage). Patient had the following side effects: bone marrow failure, dyspnoea exacerbated, hepatic failure, pneumonia (What is pneumonia?). Midazolam dosage: . During the same period patient was treated with GLEEVEC (View Gleevec Review and Gleevec Label ).

4783521-1 | Bone Marrow Depression, Dyspnoea Exacerbated, Hepatic Failure, Pneumonia
on Sep 21, 2005 Female patient from JAPAN , 54 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Midazolam (View Usage). After Midazolam was administered, patient had the following side effects: bone marrow depression, dyspnoea exacerbated, hepatic failure, pneumonia (What is pneumonia?). Midazolam dosage: . During the same period patient was treated with GLEEVEC (View Gleevec Review and Gleevec Label ).

4772706-6 | Bundle Branch Block, Cardiac Disorder, Dizziness, Hypotension, Hypoxia, Myocardial Infarction, Oxygen Saturation Decreased, Tachycardia
Patient was taking Midazolam (View Usage). Patient experienced the following unwanted or unexpected effects: bundle branch block, cardiac disorder, dizziness (What is dizziness?), hypotension, hypoxia, myocardial infarction, oxygen saturation decreased, tachycardia on Sep 15, 2005 from UNITED STATES Additional patient health information: Female patient , 87 years of age, weighting 69.00 lb, was diagnosed with sedation and. Midazolam dosage: 2 Mg Iv Oto. During the same period patient was treated with FENTANYL (150 Mg Iv Oto) (View Fentanyl Review and Fentanyl Label ), EVISTA (View Evista Review and Evista Label ), HYDRODERM/APAP (View Hydroderm/apap Review and Hydroderm/apap Label ). Patient was hospitalized.

4727460-0 | Aspiration, Cerebrovascular Accident, Cheyne-stokes Respiration, Dysphagia, Procedural Complication, Respiratory Distress, Transient Ischaemic Attack
Adverse event was reported on Jul 27, 2005 by a Female patient taking Midazolam (View Usage) (Dosage: 0.5 Mg) . Location: UNITED STATES , 83 years of age, weighting 200.0 lb, Patient had the following side effects: aspiration, cerebrovascular accident, cheyne-stokes respiration, dysphagia, procedural complication, respiratory distress, transient ischaemic attack. During the same period patient was treated with PREVACID (View Prevacid Review and Prevacid Label ), REGLAN (View Reglan Review and Reglan Label ), HEMOCYTE (View Hemocyte Review and Hemocyte Label ), DARVON (View Darvon Review and Darvon Label ), ENOXAPARIN SODIUM (View Enoxaparin Sodium Review and Enoxaparin Sodium Label ), DILANTIN (View Dilantin Review and Dilantin Label ), PROCARDIA XL (View Procardia Xl Review and Procardia Xl Label ), TOPROL XL (View Toprol-xl Review and Toprol-xl Label ). Patient was hospitalized.

4669177-7 | Cardiac Arrest, Hyperkalaemia, Hypokalaemia, Hypotension, Neuromuscular Blockade, Postpartum Sepsis, Respiratory Failure, Ventricular Tachycardia
on Apr 19, 2005 Female patient from , 35 years of age, was diagnosed with analgesic effect, sedation and was treated with Midazolam (View Usage). After Midazolam was administered, patient had the following side effects: cardiac arrest (What is cardiac arrest?), hyperkalaemia, hypokalaemia, hypotension, neuromuscular blockade, postpartum sepsis, respiratory failure, ventricular tachycardia. Midazolam dosage: . During the same period patient was treated with SUFENTANIL CITRATE (View Sufentanil Citrate Review and Sufentanil Citrate Label ), THIOPENTONE (View Thiopentone Review and Thiopentone Label ).

4653998-0 | Acute Psychosis, Heart Rate Decreased, Intentional Misuse, Irritability, Paranoia, Persecutory Delusion, Psychomotor Agitation, Somnolence
on Apr 22, 2005 Male patient from , 23 years of age, was diagnosed with depression (What is depression?) and was treated with Midazolam (View Usage). Patient experienced the following unwanted or unexpected effects: acute psychosis, heart rate decreased, intentional misuse, irritability, paranoia, persecutory delusion, psychomotor agitation, somnolence. Midazolam dosage: 7.5 Mg Nocte. During the same period patient was treated with BUPROPION (150 Mg) (View Bupropion Review and Bupropion Label ).

4650893-8 | Cardiac Arrest, Haemodialysis, Haemodynamic Instability, Hyperkalaemia, Hypokalaemia, Hypotension, Postpartum Sepsis, Respiratory Disorder, Uterine Enlargement
Patient was taking Midazolam (View Usage). Patient had the following side effects: cardiac arrest (What is cardiac arrest?), haemodialysis, haemodynamic instability, hyperkalaemia, hypokalaemia, hypotension, postpartum sepsis, respiratory disorder, uterine enlargement on Apr 19, 2005 from Additional patient health information: Female patient , 35 years of age, was diagnosed with analgesic effect, sedation and. Midazolam dosage: . During the same period patient was treated with SUFENTANIL CITRATE (View Sufentanil Citrate Review and Sufentanil Citrate Label ), THIOPENTONE (View Thiopentone Review and Thiopentone Label ).

4613643-7 | Hyperthermia Malignant, Neuroleptic Malignant Syndrome
Adverse event was reported on Mar 20, 2003 by a Male patient taking Midazolam (View Usage) (Dosage: 2.5 Mg) . Location: , 21 years of age, After Midazolam was administered, patient had the following side effects: hyperthermia malignant, neuroleptic malignant syndrome. During the same period patient was treated with FENTANYL (100 Microgram) (View Fentanyl Review and Fentanyl Label ), PROPOFOL (200 Mg) (View Propofol Review and Propofol Label ), CEFAZOLIN SODIUM (1 G) (View Cefazolin Sodium Review and Cefazolin Sodium Label ), MORPHINE SULFATE (8 Mg) (View Morphine Sulfate Review and Morphine Sulfate Label ), ONDANSETRON HYDROCHLORIDE (4 Mg) (View Ondansetron Hydrochloride Review and Ondansetron Hydrochloride Label ).

4613632-2 | Hypotension, Hypothermia, Hypoxia, Respiratory Arrest, Tachycardia
on Mar 18, 2003 Female patient from , 85 years of age, was treated with Midazolam (View Usage). Patient experienced the following unwanted or unexpected effects: hypotension, hypothermia (What is hypothermia?), hypoxia, respiratory arrest, tachycardia. Midazolam dosage: 3 Mg Once. During the same period patient was treated with FENTANYL (50 Mg Once) (View Fentanyl Review and Fentanyl Label ), PROPOFOL (30 Mg Once) (View Propofol Review and Propofol Label ), CEFTRIAXONE (1 G Once) (View Ceftriaxone Review and Ceftriaxone Label ), HYOSCINE HBR HYT (20 Mg Once) (View Hyoscine Hbr Hyt Review and Hyoscine Hbr Hyt Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ), FRUSEMIDE (View Frusemide Review and Frusemide Label ), DIGOXIN (View Digoxin Review and Digoxin Label ), RISPERIDONE (View Risperidone Review and Risperidone Label ).

4613631-0 | Anaphylactic Reaction, Angioneurotic Oedema, Cardiac Arrest, Electrocardiogram St Segment Depression
on Mar 20, 2003 Female patient from , 74 years of age, was diagnosed with sensory disturbance and was treated with Midazolam (View Usage). Patient had the following side effects: anaphylactic reaction, angioneurotic oedema, cardiac arrest (What is cardiac arrest?), electrocardiogram st segment depression. Midazolam dosage: 3 Mg Once. During the same period patient was treated with FENTANYL (View Fentanyl Review and Fentanyl Label ), ONDANSETRON (4 Mg Once) (View Ondansetron Review and Ondansetron Label ), PROPOFOL (200 Mg Total) (View Propofol Review and Propofol Label ), LIGNOCAINE (View Lignocaine Review and Lignocaine Label ), ROCURONIUM BROMIDE (View Rocuronium Bromide Review and Rocuronium Bromide Label ), IRBESARTAN (View Irbesartan Review and Irbesartan Label ), INDAPAMIDE (View Indapamide Review and Indapamide Label ), PRAVASTATIN SODIUM (View Pravastatin Sodium Review and Pravastatin Sodium Label ). Patient was hospitalized.

4613628-0 | Muscle Rigidity
Patient was taking Midazolam (View Usage). After Midazolam was administered, patient had the following side effects: muscle rigidity on Mar 19, 2003 from Additional patient health information: Male patient , 38 years of age, was diagnosed with sensory disturbance and. Midazolam dosage: 2 Mg Once. During the same period patient was treated with PROPOFOL (500 Mg Total Iv) (View Propofol Review and Propofol Label ), ALFENTANIL (2 Mg Once Iv) (View Alfentanil Review and Alfentanil Label ).

4613284-1 | Bronchospasm, Urticaria
Adverse event was reported on Mar 20, 2003 by a Female patient taking Midazolam (View Usage) (Dosage: ) was diagnosed with sensory disturbance, asthma (What is asthma?) and. Location: , 25 years of age, Patient experienced the following unwanted or unexpected effects: bronchospasm, urticaria. During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), MORPHINE SULFATE (View Morphine Sulfate Review and Morphine Sulfate Label ), ROCURONIUM BROMIDE (40 Mg Once) (View Rocuronium Bromide Review and Rocuronium Bromide Label ), ALBUTEROL (5 Mg Ih) (View Albuterol Review and Albuterol Label ).

4613283-X | Atrioventricular Block Second Degree, Hypotension, Nodal Arrhythmia
on Mar 20, 2003 Female patient from , 47 years of age, was treated with Midazolam (View Usage). Patient had the following side effects: atrioventricular block second degree, hypotension, nodal arrhythmia. Midazolam dosage: 2 Mg Once Iv. During the same period patient was treated with PROPOFOL (200 Mg Once Iv) (View Propofol Review and Propofol Label ), SUCCINYLCHOLINE CHLORIDE (100 Mg Once Iv) (View Succinylcholine Chloride Review and Succinylcholine Chloride Label ), MORPHINE SULFATE (5 Mg Once Iv) (View Morphine Sulfate Review and Morphine Sulfate Label ), FENTANYL (Iv) (View Fentanyl Review and Fentanyl Label ).

4613280-4 | Erythema, Hypertonia, Hypotension, Hypoventilation, Hypoxia, Muscle Rigidity, Tachycardia
on Mar 20, 2003 Female patient from , 29 years of age, was diagnosed with sensory disturbance and was treated with Midazolam (View Usage). After Midazolam was administered, patient had the following side effects: erythema, hypertonia, hypotension, hypoventilation, hypoxia, muscle rigidity, tachycardia. Midazolam dosage: . During the same period patient was treated with SUCCINYLCHOLINE CHLORIDE (View Succinylcholine Chloride Review and Succinylcholine Chloride Label ), PROPOFOL (View Propofol Review and Propofol Label ), MORPHINE (View Morphine Review and Morphine Label ).

4613277-4 | Hypertonia
Patient was taking Midazolam (View Usage). Patient experienced the following unwanted or unexpected effects: hypertonia on Mar 18, 2003 from Additional patient health information: Male patient , 24 years of age, . Midazolam dosage: 10 Mg Once Iv. During the same period patient was treated with HALOPERIDOL (15 Mg Once Iv) (View Haloperidol Review and Haloperidol Label ).

4609748-7 | Cardiac Arrest, Loss Of Consciousness
Adverse event was reported on Jun 25, 2004 by a Female patient taking Midazolam (View Usage) (Dosage: ) . Location: , 87 years of age, Patient had the following side effects: cardiac arrest (What is cardiac arrest?), loss of consciousness. During the same period patient was treated with KETOBEMIDONE (View Ketobemidone Review and Ketobemidone Label ).

4608629-2 | Arthralgia, Chest Pain, Procedural Hypotension
on Mar 11, 2005 Male patient from , 54 years of age, weighting 184.0 lb, was diagnosed with induction of anaesthesia and was treated with Midazolam (View Usage). After Midazolam was administered, patient had the following side effects: arthralgia, chest pain (What is chest pain?), procedural hypotension. Midazolam dosage: 1 Mg X 1 Intravenous. Patient was hospitalized.

4594195-7 | Asthma, Blood Creatine Phosphokinase Increased, Cardiac Failure Acute, Feeling Abnormal, Loss Of Consciousness, Myocardial Infarction
on Feb 16, 2005 Male patient from , 73 years of age, was diagnosed with wound complication and was treated with Midazolam (View Usage). Patient experienced the following unwanted or unexpected effects: asthma (What is asthma?), blood creatine phosphokinase increased, cardiac failure acute, feeling abnormal, loss of consciousness, myocardial infarction. Midazolam dosage: . During the same period patient was treated with SIGMART (View Sigmart Review and Sigmart Label ), VOLTAREN (25 Mg, Once/single) (View Voltaren Review and Voltaren Label ).

4587902-0 | Asthma, Cardiac Failure, Feeling Abnormal, Loss Of Consciousness, Myocardial Infarction
Patient was taking Midazolam (View Usage). Patient had the following side effects: asthma (What is asthma?), cardiac failure, feeling abnormal, loss of consciousness, myocardial infarction on Feb 16, 2005 from Additional patient health information: Male patient , 73 years of age, was diagnosed with wound complication and. Midazolam dosage: . During the same period patient was treated with SIGMART (View Sigmart Review and Sigmart Label ), VOLTAREN (View Voltaren Review and Voltaren Label ).


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Midazolam Questions, Answers, Feedback and Comments

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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Midazolam risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Midazolam quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Midazolam use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Midazolam Reactions
Acute Psychosis
Anaphylactic Reaction
Angioneurotic Oedema
Arthralgia
Aspiration
AsthmaWhat is Asthma?
Atrioventricular Block Second Degree
Blood Creatine Phosphokinase Increased
Blood Pressure Decreased
Blood Pressure Increased
Bone Marrow Depression
Bone Marrow Failure
Bronchospasm
Cardiac ArrestWhat is Cardiac arrest?
Dyspnoea Exacerbated
Feeling Abnormal
Hepatic Failure
Hyperkalaemia
Hypertonia
Hypokalaemia
Hypotension
HypothermiaWhat is Hypothermia?
Hypoxia
Loss Of Consciousness
Muscle Rigidity
Myocardial Infarction
Oxygen Saturation Decreased
PneumoniaWhat is Pneumonia?
Postpartum Sepsis
Tachycardia
Midazolam Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Midazolam adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!