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Baclofen (Baclofen) - Muscle Spasticity - Suspected Cause - Side Effect Reports

 
 



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 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 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 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 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 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 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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