Dormicum Adverse Reactions

Clinical Trials: No text.
Laboratory Abnormalities: No text.
Post Marketing: Film-coated tablet: Immune System Disorders: Hypersensitivity reactions and angioedema may occur in susceptible individuals.
Psychiatric Disorders: Confusional state, disorientation, emotional and mood disturbances. These phenomena occur predominantly at the start of therapy and usually disappear with repeated administration. Changes in libido have been reported occasionally.
Depression: Pre-existing depression may be unmasked during benzodiazepine use.
Paradoxical reactions such as restlessness, agitation, hyperactivity, nervousness, anxiety, irritability, aggressiveness, anger, nightmares, abnormal dreams, hallucinations, inappropriate behavior and other adverse behavioral effects are known to occur. Should this be the case, use of the drug should be discontinued. These effects are more likely to occur in the elderly.
Dependence: Use (even at therapeutic doses) may lead to the development of physical dependence. Abrupt discontinuation of the therapy may result in withdrawal or rebound phenomena including rebound insomnia, mood changes, anxiety and restlessness (see General under Precautions). Psychological drug dependence may occur. Abuse has been reported in poly-drug abusers.
Nervous System Disorders: Drowsiness during the day, headache, dizziness, decreased alertness, ataxia. These phenomena occur predominantly at the start of therapy and usually disappear with repeated administration.
When used as premedication, this product may contribute to post-operative sedation.
Anterograde amnesia may occur with therapeutic doses, the risk increasing at higher dosages. Amnestic effects may be associated with inappropriate behavior (see General under Precautions).
Eye Disorders: Diplopia, this phenomenon occurs predominantly at the start of therapy and usually disappears with repeated administration.
Gastrointestinal Disorders: Gastrointestinal disturbances, have been reported occasionally.
Skin and Subcutaneous Tissue Disorders: Skin reactions have been reported occasionally.
Musculoskeletal and Connective Tissue Disorders: Muscle weakness, this phenomenon occurs predominantly at the start of therapy and usually disappears with repeated administration.
General Disorders and Administration Site Conditions: Fatigue, this phenomenon occurs predominantly at the start of therapy and usually disappear with repeated administration.
Injury, Poisoning and Procedural Complications: There have been reports of falls and fractures in benzodiazepine users. The risk is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly.
Respiratory Disorders: Respiratory depression was reported.
Cardiac Disorders: Cardiac failure including cardiac arrest was reported.
Laboratory Abnormalities: No text.
Solution for injection: The following undesirable effects have been reported to occur when Midazolam (Dormicum) is injected.
Immune System Disorders: Generalized hypersensitivity reactions (skin reactions, cardiovascular reactions, bronchospasm), angioedema, anaphylactic shock.
Psychiatric Disorders: Confusional state, disorientation, emotional and mood disturbances. Changes in libido have been reported occasionally.
Paradoxical reactions such as restlessness, agitation, irritability, involuntary movements (including tonic/clonic movements and muscle tremor), hyperactivity, nervousness, hostility, anger, aggressiveness, anxiety, nightmares, abnormal dreams, hallucinations, psychoses, inappropriate behavior and other adverse behavioral effects, paroxysmal excitement and assault, have been reported, particularly among children and the elderly.
Dependence: Use of Midazolam (Dormicum) even in therapeutic doses may lead to the development of physical dependence. After prolonged I.V. administration, discontinuation, especially abrupt discontinuation of the product, may be accompanied by withdrawal symptoms including withdrawal convulsions. Abuse has been reported in poly-drug abusers.
Nervous System Disorder: Prolonged sedation, decreased alertness, headache, dizziness, ataxia, postoperative sedation, anterograde amnesia, the duration of which is directly related to the administered dose. Anterograde amnesia may still be present at the end of the procedure and in isolated cases prolonged amnesia has been reported.
Convulsions have been reported in premature infants and neonates.
Cardiac Disorders: Severe cardiorespiratory adverse events have occurred on rare occasions. These have included cardiac arrest, hypotension, bradycardia, vasodilating effects. Life-threatening incidents are more likely to occur in adults over 60 years of age and those with pre-existing respiratory insufficiency or impaired cardiac function, particularly when the injection is given too rapidly or when a high dosage is administered (see Precautions).
Respiratory Disorders: Severe cardiorespiratory adverse events have occurred on rare occasions. These have included respiratory depression, apnea, respiratory arrest, dyspnea, laryngospasm. Life-threatening incidents are more likely to occur in adults over 60 years of age and those with pre-existing respiratory insufficiency or impaired cardiac function, particularly when the injection is given too rapidly or when a high dosage is administered (see Precautions). Hiccup.
Gastrointestinal System Disorders: Nausea, vomiting, constipation, dry mouth.
Skin and Appendages Disorders: Skin rash, urticaria, pruritus.
General and Application Site Disorders: Erythema and pain on injection site, thrombophlebitis, thrombosis.
Injury, Poisoning and Procedural Complications: There have been reports of falls and fractures in benzodiazepine users. The risk is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly.
Laboratory Abnormalities: No text.