Baclofen (Baclofen) - Adverse Event Reports - Hospitalization

Drug Withdrawal Syndrome (12),  Mental Status Changes (11),  Respiratory Distress (10),  Muscle Rigidity (8),  Fatigue (8),  Confusional State (7),  Rectal Haemorrhage (7),  Aggression (7),  RED Blood Cell Count Decreased (7),  Sinus Tachycardia (7)

Adverse event in 21 year old male receiving Baclofen

Reported by a pharmacist from United States on 2007-10-25

Patient: 21 year old male, weighing 58.5 kg (128.7 pounds)

Adverse reactions / side effects: Confusional State, Medication Error, Incorrect Dose Administered, Pyrexia, Hallucination

Adverse event resulted in: hospitalization

Suspect drug(s):
Baclofen
    Dosage: 80 mg qid po 20 mg qid po
    Administration route: Oral
    Indication: Muscle Spasticity
    Start date: 2007-07-01
    End date: 2007-10-16

Baclofen
    Dosage: 80 mg qid po 20 mg qid po
    Administration route: Oral
    Indication: Muscle Spasticity
    Start date: 2007-10-16
    End date: 2007-10-23

Adverse event in 54 year old male receiving Baclofen

Reported by a pharmacist from United States on 2007-10-17

Patient: 54 year old male

Adverse reactions / side effects: Confusional State, Renal Failure, Pneumonia, Somnolence, Respiratory Distress

Adverse event resulted in: hospitalization

Suspect drug(s):
Baclofen

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 male receiving Baclofen

Reported by a consumer/non-health professional from Brazil on 2007-10-02

Patient: male, weighing 89.0 kg (195.8 pounds)

Adverse reactions / side effects: Medical Device Implantation, Pain in Extremity, Diplopia, Fatigue, Electric Shock, Nervous System Disorder, Muscle Spasms, Spinal Cord Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Lioresal
    Dosage: 8 - 10 df /day
    Administration route: Oral
    Indication: Multiple Sclerosis

Baclofen

Other drugs received by patient: Neurontin; Amplictil; Metadon; Diazepam; Amitriptyline HCL; Rivotril; Dormonid; Depakene

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 60 year old female receiving Baclofen

Reported by a consumer/non-health professional from United States on 2007-07-30

Patient: 60 year old female

Adverse reactions / side effects: Body Temperature Increased, Blood Count Abnormal, Injection Site Rash, Musculoskeletal Chest Pain, Asthenia, Multiple Sclerosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Betaseron
    Dosage: 8 miu, every 2d
    Start date: 2005-05-19

Baclofen

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 45 year old male receiving Baclofen

Reported by a health professional (non-physician/pharmacist) from Canada on 2007-07-20

Patient: 45 year old male

Adverse reactions / side effects: Blood Creatine Phosphokinase Increased, Intentional Overdose, Therapeutic Agent Toxicity, Unresponsive TO Stimuli, Vestibular Disorder, Blood Bilirubin Abnormal, Areflexia, Platelet Count Decreased, Suicide Attempt, White Blood Cell Count Increased

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Mirtazapine
    Dosage: 225 mg once oral
    Administration route: Oral

Baclofen
    Dosage: 200 mg once oral
    Administration route: Oral

Other drugs received by patient: Vecuronium Bromide; Succinylcholine Chloride; Propofol; Midazolam

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 48 year old female receiving Baclofen

Reported by a individual with unspecified qualification from United States on 2007-06-22

Patient: 48 year old female

Adverse reactions / side effects: Grand MAL Convulsion, Drug Dose Omission, Pneumonia, Unresponsive TO Stimuli, Drug Withdrawal Syndrome, Cerebrovascular Accident, Cerebellar Atrophy

Adverse event resulted in: hospitalization

Suspect drug(s):
Baclofen

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 45 year old male receiving Baclofen

Reported by a health professional (non-physician/pharmacist) from Canada on 2007-06-14

Patient: 45 year old male

Adverse reactions / side effects: Agitation, Blood Bilirubin Increased, Oculocephalogyric Reflex Absent, Blood Creatine Phosphokinase Increased, Intentional Overdose, Intubation, Unresponsive TO Stimuli, Vestibular Function Test Abnormal, Suicide Attempt, Platelet Count Decreased, White Blood Cell Count Increased

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Baclofen
    Dosage: 20 tablets of 10mg at once
    Administration route: Oral

Mirtazapine
    Dosage: 15 tablets of 15mg at once
    Administration route: Oral

Adverse event in 48 year old male receiving Baclofen

Reported by a health professional (non-physician/pharmacist) from United States on 2007-06-08

Patient: 48 year old male, weighing 80.7 kg (177.5 pounds)

Adverse reactions / side effects: Confusional State, Toxic Induced Encephalopathy, Disorientation, Hypertension

Adverse event resulted in: hospitalization

Suspect drug(s):
Methadose
    Dosage: 20 mg, bid, oral
    Administration route: Oral
    Indication: Pain
    Start date: 2006-01-10

Celebrex
    Dosage: 100 mg, bid, oral
    Administration route: Oral
    Indication: Pain
    Start date: 2006-01-10
    End date: 2006-02-15

SU 11248(su 11248) 50 MG
    Dosage: see image
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2006-01-24
    End date: 2006-02-14

SU 11248(su 11248) 50 MG
    Dosage: see image
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2006-03-07

Percocet
    Dosage: 5/325mg, 2 tablets, every 4 hrs
    Indication: Pain
    Start date: 2006-01-10
    End date: 2006-02-15

Baclofen
    Dosage: 10 mg, bid, oral
    Administration route: Oral
    Start date: 2006-01-10
    End date: 2006-02-15

Other drugs received by patient: Minocycline HCL; Lexapro; Protonix / 01263201 / (Pantoprazole); Ambien; Neurontin; Compazine / 00013302 / (Prochlorperazine Edisylate); / 00142201 / (Senna Alexandrina); Lactulose; Locace (Docusate Sodium)

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 42 year old male receiving Baclofen

Reported by a pharmacist from United States on 2007-05-31

Patient: 42 year old male

Adverse reactions / side effects: Dyspnoea, Hypoventilation, Somnolence, Loss of Consciousness, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Morphine
    Dosage: it
    Indication: Neuralgia

Baclofen
    Dosage: it
    Indication: Neuralgia

Adverse event in male receiving Baclofen

Reported by a individual with unspecified qualification from United States on 2007-05-21

Patient: male, weighing 80.7 kg (177.5 pounds)

Adverse reactions / side effects: Confusional State, Encephalopathy, Hypertension

Adverse event resulted in: hospitalization

Suspect drug(s):
Celebrex
    Administration route: Oral
    Start date: 2006-01-10
    End date: 2006-02-15

SU-011,248
    Administration route: Oral
    Indication: Renal Cell Carcinoma Stage Unspecified

Methadone HCL
    Administration route: Oral

Percocet
    Dosage: text:5/ 325 mg, 2 tablets
    Administration route: Oral
    Start date: 2006-01-10
    End date: 2006-02-15

Baclofen
    Administration route: Oral
    Start date: 2006-01-10
    End date: 2006-02-15

Other drugs received by patient: Minocycline HCL; Lexapro; Protonix; Ambien; Neurontin; Compazine; Senna; Lactulose; Colace

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

Adverse event in 45 year old female receiving Baclofen

Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-17

Patient: 45 year old female

Adverse reactions / side effects: Suicide Attempt, Multiple Drug Overdose Intentional, Depressed Level of Consciousness, Bradycardia, Respiratory Depression

Adverse event resulted in: hospitalization

Suspect drug(s):
Tramadol HCL
    Indication: Intentional Drug Misuse

Propranolol
    Indication: Intentional Drug Misuse

Baclofen
    Indication: Intentional Drug Misuse

Adverse event in 73 year old male receiving Baclofen

Reported by a physician from Spain on 2007-05-10

Patient: 73 year old male

Adverse reactions / side effects: Encephalopathy

Adverse event resulted in: hospitalization

Suspect drug(s):
Baclofen

Adverse event in 61 year old male receiving Baclofen

Reported by a physician from United States on 2007-05-01

Patient: 61 year old male

Adverse reactions / side effects: Hypotension, Pain, Suicide Attempt, Multiple Drug Overdose, Urinary Retention, Hypertension

Adverse event resulted in: hospitalization

Suspect drug(s):
Cozaar
    Administration route: Oral

Claritin
    Administration route: Oral

Dilantin
    Administration route: Oral

Baclofen
    Administration route: Oral

Adverse event in 48 year old female receiving Baclofen

Reported by a health professional (non-physician/pharmacist) from United States on 2007-04-20

Patient: 48 year old female

Adverse reactions / side effects: Pneumonia, Unresponsive TO Stimuli, Intubation, Moaning, Drug Withdrawal Syndrome, Cerebrovascular Accident, Cerebellar Atrophy, Grand MAL Convulsion

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Baclofen

Other drugs received by patient: Oxybuton; Gabapentin; Montelukast Sodium; Hydrochlorothiazide W / Irbesartan; Aspirin; Omeprazole; Atorvastatin Calcium; Sertraline; Glyburide