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Index of reports
> Cases resulting in a serious event (79)
> Cases with Mental Status Changes (11)
Below is the selection of adverse event reports related to Baclofen that includes cases resulting in a serious event where reactions include mental status changes.
Adverse event in 78 year old male receiving Baclofen
Reported by a pharmacist from United States on 2007-10-12
Patient: 78 year old male
Adverse reactions / side effects: Confusional State, Mental Status Changes
Adverse event resulted in: hospitalization
Suspect drug(s):
Baclofen
Adverse event in 49 year old male receiving Baclofen
Reported by a physician from United States on 2007-07-31
Patient: 49 year old male, weighing 73.9 kg (162.6 pounds)
Adverse reactions / side effects: Muscle Rigidity, Abdominal Tenderness, Abdominal Discomfort, Lymphocyte Count Decreased, Back Pain, Restlessness, Drug Withdrawal Syndrome, Respiratory Distress, Delirium, Tremor, Aggression, Respiratory Rate Decreased, Mental Disorder, Neutrophil Count Decreased, Drug Ineffective, Rectal Haemorrhage, Therapeutic Agent Toxicity, Drug Interaction, Mental Status Changes, Hepatomegaly, Frequent Bowel Movements, Fatigue, Overdose, Neck Pain, RED Blood Cell Count Decreased, Thrombocytopenia, Blood Pressure Increased, Haemoglobin Decreased, Anxiety, Haematochezia, Heart Rate Increased, Sinus Tachycardia, Leukopenia
Adverse event resulted in: hospitalization
Suspect drug(s):
Celexa
Indication: Depression
Pegasys
Dosage: 90 mcg sc
Indication: Hepatitis C
Start date: 2006-06-15
End date: 2007-03-01
Pegasys
Dosage: 45 mcg qd sc
Indication: Hepatitis C
Start date: 2007-03-01
Effexor
End date: 2007-04-15
Baclofen
Start date: 2007-04-17
Opiate (Nos)
Wellbutrin
Dosage: 150 mg qd po
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
Voltaren
Indication: Pain
Other drugs received by patient: Azithromycin; Hydrochlorothiazide; Toprol-XL
Adverse event in 49 year old male receiving Baclofen
Reported by a physician from United States on 2007-07-27
Patient: 49 year old male, weighing 74.0 kg (162.8 pounds)
Adverse reactions / side effects: Movement Disorder, Agitation, Blood Pressure Increased, Back Pain, Restlessness, Mental Status Changes, Drug Withdrawal Syndrome, Muscle Rigidity, Respiratory Distress, Delirium, Aggression, Tremor, Anxiety, Neck Pain, Mental Disorder, Sinus Tachycardia
Adverse event resulted in: hospitalization
Suspect drug(s):
Effexor
Dosage: unknown
End date: 2007-04-15
Celexa
Dosage: unknown
Indication: Depression
Wellbutrin
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
Baclofen
Dosage: unknown
Start date: 2007-04-17
Nicotine
Dosage: tried to smoke 2 packs in one day
Caffeine
Dosage: about 10 cups
Start date: 2007-04-17
End date: 2007-04-17
Voltaren
Dosage: unknown
Indication: Pain
Pegasys
Dosage: 90 mcg, frequency unknown
Indication: Hepatitis C
Start date: 2006-06-15
End date: 2007-03-01
Pegasys
Dosage: 45 mcg, frequency unknown
Start date: 2007-03-01
End date: 2007-05-11
Other drugs received by patient: Azithromycin; Hydrochlorothiazide; Parafon; Toprol-XL
Adverse event in 49 year old male receiving Baclofen
Reported by a consumer/non-health professional from United States on 2007-07-24
Patient: 49 year old male
Adverse reactions / side effects: Agitation, Movement Disorder, Rectal Haemorrhage, Mental Status Changes, Drug Interaction, Muscle Rigidity, Abdominal Tenderness, Abdominal Discomfort, Fatigue, Hepatomegaly, Neck Pain, RED Blood Cell Count Decreased, Thrombocytopenia, Back Pain, Restlessness, Delirium, Respiratory Distress, Tremor, Aggression, Haematochezia, Anxiety, Haemoglobin Decreased, Diarrhoea, Mental Disorder, Sinus Tachycardia, Leukopenia
Adverse event resulted in: hospitalization
Suspect drug(s):
Wellbutrin
Dosage: 150mg per day
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
Pegasys
Dosage: 45mg per day
Indication: Hepatitis C
Start date: 2006-10-15
End date: 2007-05-11
Effexor
Indication: Drug USE FOR Unknown Indication
Start date: 2006-10-01
End date: 2007-04-15
Celexa
Indication: Depression
Opiate
Baclofen
Indication: Drug USE FOR Unknown Indication
Start date: 2007-04-17
Voltaren
Other drugs received by patient: Zithromax; Hydrochlorothiazide; Toprol-XL; Antibiotic
Adverse event in 49 year old male receiving Baclofen
Reported by a physician from United States on 2007-07-12
Patient: 49 year old male
Adverse reactions / side effects: Rectal Haemorrhage, Drug Interaction, Mental Status Changes, Muscle Rigidity, Drug Toxicity, Frequent Bowel Movements, Fatigue, Overdose, RED Blood Cell Count Decreased, Thrombocytopenia, Incorrect Dose Administered, Drug Withdrawal Syndrome, Respiratory Distress, Delirium, Blood Pressure Diastolic Increased, Aggression, Sinus Tachycardia, Leukopenia
Adverse event resulted in: hospitalization
Suspect drug(s):
Baclofen
Dosage: oral
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Start date: 2007-04-17
Pegasys
Dosage: 45 mcg, subcutaneous
Indication: Hepatitis C
Start date: 2006-10-15
End date: 2007-05-11
Effexor
Dosage: oral
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
End date: 2007-04-15
Celexa
Dosage: oral
Administration route: Oral
Indication: Depression
Opiate Nos()
Indication: Drug USE FOR Unknown Indication
Wellbutrin
Dosage: oral
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
Other drugs received by patient: Zithromax Z-Pack (Azthromycin); Hydrochlorothiazide; Toprol-XL; Ativan; Benadryl; Cogentin (Benzatorpine Mesilate)
Adverse event in 49 year old male receiving Baclofen
Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-06
Patient: 49 year old male, weighing 73.9 kg (162.6 pounds)
Adverse reactions / side effects: Back Pain, Rectal Haemorrhage, Mental Status Changes, Abdominal Pain Upper, Haemoglobin Decreased, Haematochezia, Abdominal Discomfort, Hepatomegaly, Fatigue, Diarrhoea, Neck Pain, RED Blood Cell Count Decreased, Thrombocytopenia, Leukopenia
Adverse event resulted in: hospitalization
Suspect drug(s):
Pegasys
Indication: Hepatitis C
Start date: 2006-06-01
End date: 2007-03-01
Pegasys
Start date: 2007-03-01
End date: 2007-05-11
Effexor
Indication: Drug USE FOR Unknown Indication
End date: 2007-04-01
Celexa
Indication: Depression
Baclofen
Indication: Drug USE FOR Unknown Indication
Opiate NOS
Indication: Drug USE FOR Unknown Indication
Wellbutrin
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
Voltaren
Other drugs received by patient: Zithromax; Hydrochlorothiazide; Toprol-XL; Ativan; Benadryl; Cogentin; Parafon
Adverse event in 49 year old male receiving Baclofen
Reported by a health professional (non-physician/pharmacist) from United States on 2007-06-26
Patient: 49 year old male
Adverse reactions / side effects: Agitation, Drug Ineffective, Dyskinesia, Rectal Haemorrhage, Drug Interaction, Mental Status Changes, Prothrombin Time Prolonged, Muscle Rigidity, Frequent Bowel Movements, Overdose, Fatigue, RED Blood Cell Count Decreased, Depression, Thrombocytopenia, White Blood Cell Count Decreased, Blood Pressure Increased, Blood Urea Increased, Restlessness, International Normalised Ratio Increased, Drug Withdrawal Syndrome, Blood Bicarbonate Decreased, Delirium, Respiratory Distress, Aggression, Tremor, Haematochezia, Anxiety, Heart Rate Increased, Mental Disorder, Sinus Tachycardia, Leukopenia
Adverse event resulted in: hospitalization
Suspect drug(s):
Celexa
Indication: Depression
Pegasys
Dosage: 45 mcg sc
Indication: Hepatitis C
Start date: 2006-10-15
End date: 2007-05-11
Baclofen
Start date: 2007-04-17
Opiate (Nos)
Wellbutrin
Dosage: 150 mg qd po
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
Other drugs received by patient: Effexor; Azithromycin; Hydrochlorothiazide; Toprol-XL
Adverse event in 49 year old male receiving Baclofen
Reported by a consumer/non-health professional from United States on 2007-06-20
Patient: 49 year old male
Adverse reactions / side effects: Agitation, Movement Disorder, Rectal Haemorrhage, Drug Interaction, Mental Status Changes, Muscle Rigidity, Fatigue, RED Blood Cell Count Decreased, Thrombocytopenia, Restlessness, Respiratory Distress, Delirium, Tremor, Aggression, Haematochezia, Anxiety, Diarrhoea, Mental Disorder, Sinus Tachycardia, Leukopenia
Adverse event resulted in: hospitalization
Suspect drug(s):
Wellbutrin
Dosage: 150mg per day
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
Pegasys
Dosage: 45mg per day
Indication: Hepatitis C
Start date: 2006-10-15
End date: 2007-05-11
Effexor
Indication: Drug USE FOR Unknown Indication
Start date: 2006-10-01
End date: 2007-04-15
Celexa
Indication: Depression
Opiate
Baclofen
Indication: Drug USE FOR Unknown Indication
Start date: 2007-04-17
Other drugs received by patient: Zithromax; Hydrochlorothiazide; Toprol-XL; Antibiotic
Adverse event in 49 year old male receiving Baclofen
Reported by a physician from United States on 2007-06-20
Patient: 49 year old male
Adverse reactions / side effects: Blood Pressure Increased, Agitation, Movement Disorder, Restlessness, Mental Status Changes, Drug Withdrawal Syndrome, Muscle Rigidity, Delirium, Respiratory Distress, Tremor, Aggression, Anxiety, Mental Disorder, Sinus Tachycardia
Adverse event resulted in: hospitalization
Suspect drug(s):
Effexor
Dosage: unknown
End date: 2007-04-15
Celexa
Dosage: unknown
Indication: Depression
Caffeine
Dosage: about 10 cups
Start date: 2007-04-17
End date: 2007-04-17
Bupropion Hydrochloride
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
Baclofen
Dosage: unknown
Start date: 2007-04-17
Nicotine
Dosage: tried to smoke 2 packs in one day
Pegasys
Dosage: 45 mcg, frequency unknown
Indication: Hepatitis C
Start date: 2006-10-15
End date: 2007-05-11
Other drugs received by patient: Azithromycin; Toprol-XL; Hydrochlorothiazide
Adverse event in 49 year old male receiving Baclofen
Reported by a health professional (non-physician/pharmacist) from United States on 2007-06-01
Patient: 49 year old male
Adverse reactions / side effects: Haematochezia, Fatigue, Diarrhoea, RED Blood Cell Count Decreased, Rectal Haemorrhage, Mental Status Changes, Thrombocytopenia, Leukopenia
Adverse event resulted in: hospitalization
Suspect drug(s):
Pegasys
Indication: Hepatitis C
Start date: 2006-10-01
End date: 2007-05-11
Effexor
Indication: Drug USE FOR Unknown Indication
End date: 2007-04-01
Celexa
Indication: Depression
Baclofen
Indication: Drug USE FOR Unknown Indication
Opiate NOS
Indication: Drug USE FOR Unknown Indication
Wellbutrin
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
Other drugs received by patient: Zithromax; Hydrochlorothiazide; Toprol-XL; Ativan; Benadryl; Cogentin
Adverse event in 64 year old male receiving Baclofen
Reported by a pharmacist from United States on 2007-05-18
Patient: 64 year old male
Adverse reactions / side effects: Overdose, Dementia, Mental Status Changes, Bradycardia, Loss of Consciousness
Adverse event resulted in: hospitalization
Suspect drug(s):
Baclofen
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