Index of reports
> Cases with Muscle Spasticity (48)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Baclofen where reactions include muscle spasticity. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 48 Next >>
Possible Baclofen side effects in 26 year old female
Reported by a physician from United States on 2012-08-27
Patient: 26 year old female
Reactions: Urinary Tract Infection, Abulia, Clostridium Difficile Colitis, Condition Aggravated, Muscle Spasticity, Delusion, Therapeutic Response Decreased, Hallucinations, Mixed, Insomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Dosage: unk
Indication: Muscle Spasticity
Olanzapine
Dosage: 20 mg daily
Olanzapine
Dosage: unk
Indication: Psychiatric Symptom
Risperidone
Dosage: unk
Indication: Psychiatric Symptom
Ziprasidone HCL
Dosage: unk
Indication: Psychiatric Symptom
Possible Baclofen side effects in 26 year old female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 26 year old female
Reactions: Device Damage, Underdose, Muscle Spasticity, Device Dislocation, Muscle Rigidity, Convulsion, Crying, Spinal Column Stenosis
Drug(s) suspected as cause:
Baclofen
Other drugs received by patient: Morphine
Possible Baclofen side effects in 42 year old male
Reported by a physician from Japan on 2012-07-24
Patient: 42 year old male
Reactions: Postoperative Adhesion, Dystonia, Device Damage, General Physical Health Deterioration, Drug Withdrawal Syndrome, Muscle Spasticity, Gait Spastic, Device Failure, Device Connection Issue, Device Breakage, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in 53 year old female
Reported by a physician from United States on 2012-07-11
Patient: 53 year old female
Reactions: Muscle Spasticity
Drug(s) suspected as cause:
Baclofen
Dosage: ug, once/hour, intrathecal
Prialt
Dosage: ug, once/hour, intrathecal
Possible Baclofen side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28
Patient: female
Reactions: Incontinence, Drug Ineffective, Hypotonia, Sensory Loss, Immune System Disorder, Muscle Spasticity, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in female
Reported by a physician from Japan on 2012-06-26
Patient: female
Reactions: Spinal Cord Infarction, Muscle Spasticity
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: female
Reactions: Weight Decreased, Movement Disorder, Post Procedural Complication, Device Extrusion, Muscle Spasticity, Therapeutic Response Decreased, Activities of Daily Living Impaired, Implant Site Erythema, Frustration, Mobility Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in 40 year old female
Reported by a physician from Japan on 2012-06-19
Patient: 40 year old female
Reactions: Swelling Face, Body Temperature Increased, Hypothermia, Condition Aggravated, Muscle Spasticity, Drug Withdrawal Syndrome, Overdose, Oedema Peripheral, Myotonia, Hypertonia, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in 6 year old male
Reported by a physician from Japan on 2012-06-19
Patient: 6 year old male, weighing 21.0 kg (46.2 pounds)
Reactions: Medical Device Complication, Product Quality Issue, Implant Site Infection, Implant Site Effusion, Muscle Spasticity, CSF Culture Positive, Staphylococcal Infection, Fluid Retention, Device Breakage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in female
Reported by a physician from United States on 2012-06-16
Patient: female
Reactions: Blood Bilirubin Increased, Haemorrhage, Coagulopathy, Muscle Spasticity, Platelet Disorder, Chronic Lymphocytic Leukaemia, Musculoskeletal Stiffness, Thrombocytopenia, Retroperitoneal Haemorrhage, Pneumonia, Anaemia, Malnutrition, Atrial Fibrillation, Hepatic Enzyme Increased, Cholelithiasis, Urinary Tract Infection Enterococcal, Weaning Failure, Activities of Daily Living Impaired, Fungal Infection, Respiratory Failure, Bacteraemia, Respiratory Acidosis, Asthenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Baclofen
Dosage: see b5
Indication: Spinal Cord Injury
Baclofen
Dosage: see b5
Indication: Muscle Spasticity
Possible Baclofen side effects in 51 year old male
Reported by a physician from United Kingdom on 2012-06-15
Patient: 51 year old male
Reactions: Medical Device Complication, Urinary Tract Infection, Muscular Weakness, Condition Aggravated, Muscle Spasticity, Nerve Compression, Muscle Strain, Ileus, Influenza
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Other drugs received by patient: Aspirin; Sitagliptin; Dipyridamole; Folic Acid; Simvastatin; Acetaminophen and Codeine Phosphate; Tizandine; Vitamin B Complex CAP; Albuterol Sulate; Ramipril; Metformin HCL
Possible Baclofen side effects in 51 year old male
Reported by a physician from United Kingdom on 2012-06-05
Patient: 51 year old male
Reactions: Vomiting, Musculoskeletal Pain, Urinary Tract Infection, Muscular Weakness, Condition Aggravated, Muscle Spasticity, Device Dislocation, Nerve Compression, Malaise, Postoperative Ileus, Excessive Exercise, Influenza
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in male
Reported by a physician from United States on 2012-05-31
Patient: male
Reactions: Urinary Tract Infection, Device Damage, Implant Site Infection, Mental Status Changes, Implant Site Effusion, Condition Aggravated, Muscle Spasticity, Drug Withdrawal Syndrome, Device Failure, Device Leakage, Device Alarm Issue, Device Connection Issue
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Dosage: 360 mcg/day
Indication: Spinal Cord Injury
Baclofen
Dosage: 360 mcg/day
Indication: Muscle Spasticity
Possible Baclofen side effects in 53 year old male
Reported by a physician from Saudi Arabia on 2012-05-30
Patient: 53 year old male
Reactions: Scoliosis, Muscle Spasticity
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-30
Patient: female
Reactions: Medical Device Complication, Drug Effect Decreased, Muscle Spasticity
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in 14 year old male
Reported by a physician from Japan on 2012-05-25
Patient: 14 year old male, weighing 35.0 kg (77.0 pounds)
Reactions: Increased Upper Airway Secretion, Condition Aggravated, Muscle Spasticity, Respiratory Depression, Hypopnoea, Anticonvulsant Drug Level Increased, Glossoptosis, Obstructive Airways Disorder, Oxygen Saturation Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Other drugs received by patient: Diazepam; Periactin; Dantrium; Phenobarbital TAB; Symmetrel; Benzaline
Possible Baclofen side effects in 13 year old male
Reported by a physician from United States on 2012-05-22
Patient: 13 year old male
Reactions: Tachycardia, Muscle Spasticity, Drug Withdrawal Syndrome, Pyrexia
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in 79 year old
Reported by a physician from Japan on 2012-05-18
Patient: 79 year old
Reactions: Disease Complication, Pneumonia Aspiration, Dysphagia, Respiratory Failure, Condition Aggravated, Muscle Spasticity, Somnolence
Adverse event resulted in: death
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in female
Reported by a physician from United States on 2012-05-15
Patient: female
Reactions: Medical Device Complication, Confusional State, Agitation, Pruritus, Unresponsive To Stimuli, Pain, Mental Status Changes, Drug Withdrawal Syndrome, Muscle Spasticity, Musculoskeletal Stiffness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Dosage: 1400mcg/day ; 2000mcg/ml
Indication: Muscle Spasticity
Baclofen
Dosage: 1400mcg/day ; 2000mcg/ml
Indication: Cerebral Palsy
Possible Baclofen side effects in 40 year old female
Reported by a physician from Japan on 2012-05-14
Patient: 40 year old female
Reactions: Swelling Face, Overdose, Hypothermia, Oedema Peripheral, Muscle Spasticity, Hypertonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-14
Patient: male
Reactions: Pneumonia, Vomiting, Disease Recurrence, Pain in Extremity, Drug Ineffective, Suicide Attempt, Muscle Spasticity, Feeling Abnormal, Disease Progression
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Baclofen
Indication: Muscle Spasticity
Baclofen
Indication: Paraparesis
Other drugs received by patient: Baclofen
Possible Baclofen side effects in female
Reported by a physician from Canada on 2012-05-11
Patient: female
Reactions: Neoplasm Malignant, Condition Aggravated, Muscle Spasticity
Drug(s) suspected as cause:
Baclofen
Other drugs received by patient: Baclofen
Possible Baclofen side effects in 53 year old female
Reported by a physician from Japan on 2012-05-07
Patient: 53 year old female
Reactions: Drug Ineffective, Dyskinesia, Condition Aggravated, Muscular Weakness, Muscle Spasticity, Device Occlusion, Tremor, Activities of Daily Living Impaired, Muscle Spasms, Device Breakage
Drug(s) suspected as cause:
Baclofen
Other drugs received by patient: Ibruprofen; Myonal; Cravat
Possible Baclofen side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-02
Patient: female
Reactions: Blood Bilirubin Increased, Haemorrhage, Coagulopathy, Muscle Spasticity, Pyrexia, Platelet Disorder, Musculoskeletal Stiffness, Thrombocytopenia, Retroperitoneal Haemorrhage, Pneumonia, Malnutrition, Atrial Fibrillation, Haemorrhagic Anaemia, Respiratory Distress, Hepatic Enzyme Increased, Urinary Tract Infection Enterococcal, Weaning Failure, Cholelithiasis, Respiratory Acidosis, Bacteraemia, Fungal Infection, Respiratory Failure, Asthenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Baclofen
Dosage: see b5
Indication: Muscle Spasticity
Baclofen
Dosage: see b5
Indication: Spinal Cord Injury
Possible Baclofen side effects in female
Reported by a physician from United States on 2012-05-01
Patient: female
Reactions: Brain Oedema, Mental Status Changes, Meningitis, Muscle Spasticity, Convulsion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Baclofen
Dosage: see image
Indication: Muscle Spasticity
Baclofen
Dosage: see image
Indication: Spinal Cord Injury
Possible Baclofen side effects in female
Reported by a physician from United States on 2012-04-27
Patient: female
Reactions: Medical Device Complication, Abnormal Behaviour, Muscle Spasticity, Disorientation, Overdose, Dizziness, Asthenia, Feeling Drunk
Drug(s) suspected as cause:
Baclofen
Dosage: 340 mcg, daily, intrath
Indication: Muscle Spasticity
Baclofen
Dosage: 340 mcg, daily, intrath
Indication: Multiple Sclerosis
Possible Baclofen side effects in 40 year old female
Reported by a physician from Japan on 2012-04-20
Patient: 40 year old female
Reactions: Medical Device Complication, Swelling Face, Hypothermia, Condition Aggravated, Muscle Spasticity, Drug Withdrawal Syndrome, Muscle Tightness, Overdose, Activities of Daily Living Impaired, Oedema Peripheral, Myotonia, Hypertonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in female
Reported by a physician from United States on 2012-04-17
Patient: female
Reactions: Confusional State, Medical Device Complication, Agitation, Pruritus, Pain, Unresponsive To Stimuli, Mental Status Changes, Muscle Spasticity, Drug Withdrawal Syndrome, Muscle Rigidity, Musculoskeletal Stiffness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
Dosage: 1400mcg/day ; 2000mcg/ml
Indication: Cerebral Palsy
Baclofen
Dosage: 1400mcg/day ; 2000mcg/ml
Indication: Muscle Spasticity
Possible Baclofen side effects in male
Reported by a physician from Japan on 2012-04-03
Patient: male, weighing 67.0 kg (147.4 pounds)
Reactions: Medical Device Complication, Implant Site Effusion, Device Connection Issue, Muscle Spasticity, Device Breakage
Drug(s) suspected as cause:
Baclofen
Possible Baclofen side effects in 6 year old male
Reported by a physician from Japan on 2012-04-02
Patient: 6 year old male
Reactions: Medical Device Complication, Wound, Implant Site Infection, Muscle Spasticity, Implant Site Reaction, Staphylococcal Infection, Procedural Complication, Bacterial Test Positive, Blister
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Baclofen
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