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This is an index of reports of adverse events (side effects, adverse reactions, etc.) related to Baclofen. Click on the relevant link below to view a selection of reports according to the event's seriousness level and/or the nature of the side effect / adverse reaction. Or scroll down to view a sample of recent reports further on this page.
Our database includes reports from Jan 2007 to Dec 2007. The information is not vetted and should not be cosidered as verified clinical evidence.
All cases (84)
Cases resulting in a serious event (79)
Cases resulting in death (10)
Cases resulting in life threatening events (9)
Cases resulting in hospitalization (47)
Cases resulting in disability (2)
Cases resulting in other serious reactions (25)
Below is a sample of reports where side effects / adverse reactions may be related to Baclofen. For a complete list and/or a specific selection of reports, please use the links in the index above.
Adverse event in male receiving Baclofen
Reported by a individual with unspecified qualification from United States on 2007-10-29
Patient: male
Adverse reactions / side effects: Pelvic Organ Injury, Abasia, Liver Disorder, Malaise, Liver Function Test Abnormal, Musculoskeletal Stiffness, Dizziness, Muscle Spasms, Hypertonia, Back Pain, Medical Device Complication, Vomiting, Abdominal Injury, Nausea, Renal Cyst, Hypoaesthesia, Paraesthesia, Activities of Daily Living Impaired, Gait Disturbance
Suspect drug(s):
Baclofen
Dosage: df intrathecal
Indication: Muscle Spasticity
Zanaflex
Dosage: df
Indication: Drug USE FOR Unknown Indication
Other drugs received by patient: Klonopin
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 male receiving Baclofen
Reported by a consumer/non-health professional from United States on 2007-10-24
Patient: male
Adverse reactions / side effects: Drug Effect Decreased, Male Orgasmic Disorder
Suspect drug(s):
Baclofen
Flomax
Administration route: Oral
Indication: Bladder Disorder
Start date: 2003-01-01
Adverse event in 32 year old female receiving Baclofen
Reported by a individual with unspecified qualification from United States on 2007-10-18
Patient: 32 year old female
Adverse reactions / side effects: Drug Exposure During Pregnancy, Blighted Ovum, Abortion Spontaneous, Pregnancy
Suspect drug(s):
Baclofen
Indication: Muscle Spasms
End date: 2007-03-01
Celexa
Indication: Depression
End date: 2007-03-01
Dynacin
Indication: Sweat Gland Infection
End date: 2007-03-01
Provigil
Indication: Fatigue
End date: 2007-03-01
Rebif
Dosage: 44 mcg/3 times wkly/sc
Indication: Multiple Sclerosis
Start date: 2006-03-14
End date: 2007-03-01
Relpax
Dosage: prn
Indication: Migraine
End date: 2007-03-01
Seroquel
Indication: Insomnia
End date: 2007-03-01
Vesicare
Indication: Bladder Disorder
End date: 2007-03-01
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 32 year old female receiving Baclofen
Reported by a consumer/non-health professional from United States on 2007-10-15
Patient: 32 year old female
Adverse reactions / side effects: Drug Exposure During Pregnancy, Abortion Spontaneous
Suspect drug(s):
Baclofen
Indication: Muscle Spasms
End date: 2007-03-01
Celexa
Indication: Depression
End date: 2007-03-01
Minocycline(minocycline Hydrochloride
Indication: Sweat Gland Infection
End date: 2007-03-01
Provigil
Indication: Fatigue
End date: 2007-03-01
Rebif
Dosage: 44 other, subcutaneous
Indication: Multiple Sclerosis
Start date: 2006-03-14
End date: 2007-03-01
Relpax
Indication: Migraine
End date: 2007-03-01
Seroquel
Indication: Insomnia
End date: 2007-03-01
Vesicare
Indication: Urinary Tract Disorder
End date: 2007-03-01
Adverse event in female receiving Baclofen
Reported by a consumer/non-health professional from United States on 2007-10-15
Patient: female, weighing 61.7 kg (135.7 pounds)
Adverse reactions / side effects: Road Traffic Accident, Drug Ineffective, Pain
Suspect drug(s):
Baclofen
Indication: Pain
Baclofen
Indication: Muscle Spasms
Lyrica
Indication: Fibromyalgia
Lyrica
Indication: Pain
Lyrica
Indication: Muscle Spasms
Other drugs received by patient: Cymbalta; Lidoderm; Percocet; Nexium; Valium; Estradiol; Oxycodone HCL; Diclofenac Sodium
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 32 year old female receiving Baclofen
Reported by a individual with unspecified qualification from United States on 2007-10-09
Patient: 32 year old female
Adverse reactions / side effects: Drug Exposure During Pregnancy, Drug Exposure Before Pregnancy, Abortion Spontaneous, Pregnancy
Suspect drug(s):
Interferon Beta-1A
Dosage: 18.8571 mc (44 mcg, 3 in 1 wk)
Indication: Multiple Sclerosis
Start date: 2006-03-14
End date: 2007-03-01
Baclofen
Start date: 2007-03-01
Citalopram Hydrobromide
Start date: 2007-03-01
Eletriptan Hydrobromide
Indication: Migraine
Start date: 2007-03-01
Minocycline HCL
Indication: Sweat Gland Infection
Start date: 2007-03-01
Modafinil
Indication: Fatigue
Start date: 2007-03-01
Quetiapine Fumarate
Indication: Insomnia
Start date: 2007-03-01
Solifenacin
Indication: Bladder Disorder
Start date: 2007-03-01
Adverse event in female receiving Baclofen
Reported by a consumer/non-health professional from United States on 2007-10-02
Patient: female
Adverse reactions / side effects: Abortion Spontaneous
Suspect drug(s):
Baclofen
Indication: Muscle Spasms
Celexa
Indication: Depression
Minocycline HCL
Indication: Sweat Gland Infection
Provigil
Indication: Fatigue
Rebif
Indication: Multiple Sclerosis
Start date: 2006-03-14
End date: 2007-03-01
Relpax
Indication: Migraine
Seroquel
Indication: Insomnia
Vesicare
Indication: Bladder Disorder
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):
Baclofen
Lioresal
Dosage: 8 - 10 df /day
Administration route: Oral
Indication: Multiple Sclerosis
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):
Baclofen
Start date: 2007-04-17
Celexa
Indication: Depression
Effexor
End date: 2007-04-15
Opiate (Nos)
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
Voltaren
Indication: Pain
Wellbutrin
Dosage: 150 mg qd po
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
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):
Baclofen
Betaseron
Dosage: 8 miu, every 2d
Start date: 2005-05-19
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):
Baclofen
Dosage: unknown
Start date: 2007-04-17
Caffeine
Dosage: about 10 cups
Start date: 2007-04-17
End date: 2007-04-17
Celexa
Dosage: unknown
Indication: Depression
Effexor
Dosage: unknown
End date: 2007-04-15
Nicotine
Dosage: tried to smoke 2 packs in one day
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
Voltaren
Dosage: unknown
Indication: Pain
Wellbutrin
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
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):
Baclofen
Indication: Drug USE FOR Unknown Indication
Start date: 2007-04-17
Celexa
Indication: Depression
Effexor
Indication: Drug USE FOR Unknown Indication
Start date: 2006-10-01
End date: 2007-04-15
Opiate
Pegasys
Dosage: 45mg per day
Indication: Hepatitis C
Start date: 2006-10-15
End date: 2007-05-11
Voltaren
Wellbutrin
Dosage: 150mg per day
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
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):
Baclofen
Dosage: 200 mg once oral
Administration route: Oral
Mirtazapine
Dosage: 225 mg once oral
Administration route: Oral
Other drugs received by patient: Vecuronium Bromide; Succinylcholine Chloride; Propofol; Midazolam
Adverse event in 51 year old male receiving Baclofen
Reported by a physician from United States on 2007-07-18
Patient: 51 year old male
Adverse reactions / side effects: Sudden Cardiac Death, Myocardial Infarction
Adverse event resulted in: death
Suspect drug(s):
Baclofen
Dosage: 120 mg (40 mg, 3 in 1 d), oral
Administration route: Oral
Indication: Multiple Sclerosis
Mitoxantrone
Dosage: based on 12 mg per meter squared of body surface area (24 mg, 1 in 3 m), intravenous (not otherwise
Indication: Progressive Multiple Sclerosis
Start date: 2002-01-08
End date: 2003-11-11
Other drugs received by patient: Amantadine HCL
Adverse event in 32 year old male receiving Baclofen
Reported by a individual with unspecified qualification from United States on 2007-07-13
Patient: 32 year old male
Adverse reactions / side effects: Agitation, Psychotic Disorder, Social Avoidant Behaviour, Hallucination, Auditory, Fear, Delusion
Suspect drug(s):
Baclofen
Other drugs received by patient: Antibiotics; Olanzapine; Nsaid's
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
Celexa
Dosage: oral
Administration route: Oral
Indication: Depression
Effexor
Dosage: oral
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
End date: 2007-04-15
Opiate Nos()
Indication: Drug USE FOR Unknown Indication
Pegasys
Dosage: 45 mcg, subcutaneous
Indication: Hepatitis C
Start date: 2006-10-15
End date: 2007-05-11
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 30 year old male receiving Baclofen
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2007-07-09
Patient: 30 year old male
Adverse reactions / side effects: Loss of Consciousness
Adverse event resulted in: life threatening event
Suspect drug(s):
Baclofen
Adverse event in 40 year old male receiving Baclofen
Reported by a physician from United States on 2007-07-09
Patient: 40 year old male
Adverse reactions / side effects: Drug Toxicity
Suspect drug(s):
Baclofen
Administration route: Oral
Lioresal
Indication: Muscle Spasticity
Oxycodone HCL
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):
Baclofen
Indication: Drug USE FOR Unknown Indication
Celexa
Indication: Depression
Effexor
Indication: Drug USE FOR Unknown Indication
End date: 2007-04-01
Opiate NOS
Indication: Drug USE FOR Unknown Indication
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
Voltaren
Wellbutrin
Administration route: Oral
Indication: Depression
Start date: 2007-04-17
Other drugs received by patient: Zithromax; Hydrochlorothiazide; Toprol-XL; Ativan; Benadryl; Cogentin; Parafon
Adverse event in 50 year old male receiving Baclofen
Reported by a pharmacist from United States on 2007-07-05
Patient: 50 year old male
Adverse reactions / side effects: Drug Effect Decreased, Pharmaceutical Product Complaint
Suspect drug(s):
Baclofen
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):
Baclofen
Start date: 2007-04-17
Celexa
Indication: Depression
Opiate (Nos)
Pegasys
Dosage: 45 mcg sc
Indication: Hepatitis C
Start date: 2006-10-15
End date: 2007-05-11
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
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