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

 
 



Index of reports > Cases with Muscle Spasms (61)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Baclofen where reactions include muscle spasms. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 61   Next >>

Possible Baclofen side effects in 55 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-07

Patient: 55 year old female

Reactions: Drug Interaction, Headache, Disorientation, Somnolence, Pulse Pressure Increased, Balance Disorder, Palpitations, Dizziness, Hallucination, Muscle Spasms, Dyspnoea, Vomiting, Urinary Tract Infection, Anxiety, Euphoric Mood, Hypopnoea, Diarrhoea, Disturbance in Attention, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Baclofen
    Dosage: 60 mg as needed
    Indication: Muscle Spasms

Butrans
    Dosage: 240 i?g
    Start date: 2011-01-01
    End date: 2011-01-01

Butrans
    Dosage: 480 i?g

Butrans
    Dosage: 480 i?g
    Indication: Pain
    Start date: 2011-08-01
    End date: 2011-01-01

Butrans
    Dosage: 360 i?g
    Start date: 2011-01-01
    End date: 2011-01-01

Butrans
    Dosage: 120 i?g
    Start date: 2011-01-01
    End date: 2011-01-01

Cesamet
    Dosage: 0.5 mg
    Administration route: Oral
    Indication: Back Pain
    End date: 2011-08-01

Clonazepam
    Dosage: 3 mg
    Administration route: Oral
    Indication: Anxiety
    Start date: 2011-12-11

Escitalopram
    Dosage: 20 mg
    Administration route: Oral
    Indication: Anxiety
    End date: 2011-08-01

Other drugs received by patient: Cipro XR



Possible Baclofen side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: male

Reactions: Back Pain, Pleurisy, Sciatica, Restless Legs Syndrome, Breakthrough Pain, Inadequate Analgesia, Drug Withdrawal Syndrome, Hyperhidrosis, Neck Pain, Oedema Peripheral, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Post Laminectomy Syndrome

Baclofen
    Indication: Pain



Possible Baclofen side effects in 55 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-31

Patient: 55 year old female

Reactions: Drug Interaction, Headache, Disorientation, Somnolence, Pulse Pressure Increased, Balance Disorder, Palpitations, Dizziness, Hallucination, Muscle Spasms, Dyspnoea, Vomiting, Urinary Tract Infection, Anxiety, Euphoric Mood, Diarrhoea, Hypopnoea, Disturbance in Attention, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Baclofen
    Dosage: 60 mg (20 mg,3 in 1 d)

Buprenorphine
    Dosage: 240 mcg(10mcg,1 in 1 hr),360 mcg(15mcg,1 in 1 hr),480 mcg (20mcg,1 in 1 hr),120 mcg (5 mcg,1 in 1 hr

Cesamet
    Dosage: (0.25 mg), oral
    Administration route: Oral

Clonazepam
    Dosage: 3 mg (1 mg,3 in 1 d), oral
    Administration route: Oral

Escitalopram Oxalate
    Dosage: 20 mg (20 mg, 1 in 1 d),oral
    Administration route: Oral



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 48 year old female

Reported by a physician from United States on 2012-07-17

Patient: 48 year old female

Reactions: Hyperhidrosis, Muscle Spasms

Drug(s) suspected as cause:
Baclofen
    Dosage: 474.2 mcg/day
    Indication: Spinal Cord Injury

Baclofen
    Dosage: 474.2 mcg/day
    Indication: Muscle Spasticity

Other drugs received by patient: Morphine Sulfate



Possible Baclofen side effects in 30 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-16

Patient: 30 year old male, weighing 50.8 kg (111.8 pounds)

Reactions: Vomiting, Psychomotor Hyperactivity, Diarrhoea, Drug Ineffective, Withdrawal Syndrome, Hallucination, Muscle Spasms

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Baclofen
    Dosage: 10 mg, tid
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Dosage: unk
    Indication: Lower Respiratory Tract Infection
    Start date: 2012-05-25
    End date: 2012-06-02



Possible Baclofen side effects in 46 year old female

Reported by a physician from Japan on 2012-07-13

Patient: 46 year old female

Reactions: Postoperative Adhesion, Ileus, Drug Ineffective, Intestinal Obstruction, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in 30 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-13

Patient: 30 year old male, weighing 50.8 kg (111.8 pounds)

Reactions: Vomiting, Psychomotor Hyperactivity, Diarrhoea, Drug Ineffective, Withdrawal Syndrome, Hallucination, Muscle Spasms

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Baclofen
    Dosage: 10 mg, tid
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Dosage: 250 mg, daily
    Indication: Lower Respiratory Tract Infection
    Start date: 2012-05-25
    End date: 2012-06-02



Possible Baclofen side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-10

Patient: male

Reactions: Pruritus, NO Therapeutic Response, Erection Increased, Hyperhidrosis, Muscle Spasms

Drug(s) suspected as cause:
Baclofen
    Indication: Muscle Spasticity

Baclofen
    Indication: Head Injury

Baclofen
    Indication: Brain Injury



Possible Baclofen side effects in 48 year old female

Reported by a physician from United States on 2012-07-10

Patient: 48 year old female

Reactions: Hyperhidrosis, Muscle Spasms

Drug(s) suspected as cause:
Baclofen
    Dosage: 474.2 mcg/day
    Indication: Muscle Spasticity

Baclofen
    Dosage: 474.2 mcg/day
    Indication: Spinal Cord Injury

Baclofen
    Dosage: 474.2 mcg/day
    Indication: Spinal Cord Disorder

Other drugs received by patient: Morphine Sulfate



Possible Baclofen side effects in 30 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-09

Patient: 30 year old male, weighing 50.8 kg (111.8 pounds)

Reactions: Psychomotor Hyperactivity, Vomiting, Drug Ineffective, Diarrhoea, Withdrawal Syndrome, Hallucination, Muscle Spasms

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Baclofen
    Dosage: 10 mg, tid

Clarithromycin
    Dosage: 250 mg, unk
    Indication: Lower Respiratory Tract Infection
    Start date: 2012-05-25
    End date: 2012-06-02



Possible Baclofen side effects in 30 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-09

Patient: 30 year old male, weighing 50.8 kg (111.8 pounds)

Reactions: Psychomotor Hyperactivity, Vomiting, Drug Ineffective, Diarrhoea, Withdrawal Syndrome, Hallucination, Muscle Spasms

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Baclofen
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Indication: Lower Respiratory Tract Infection
    Start date: 2012-05-25
    End date: 2012-06-02



Possible Baclofen side effects in 61 year old male

Reported by a physician from Japan on 2012-07-06

Patient: 61 year old male

Reactions: Insomnia, Muscular Weakness, Gait Disturbance, Muscle Spasms, Lumbar Spinal Stenosis

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in 48 year old female

Reported by a physician from United States on 2012-07-06

Patient: 48 year old female

Reactions: Muscle Spasms

Drug(s) suspected as cause:
Baclofen
    Dosage: 474.2 mcg/day
    Indication: Spinal Cord Injury

Baclofen
    Dosage: 474.2 mcg/day
    Indication: Muscle Spasticity

Other drugs received by patient: Morphine Sulfate



Possible Baclofen side effects in 73 year old male

Reported by a physician from Japan on 2012-07-06

Patient: 73 year old male

Reactions: Disease Complication, Respiratory Failure, Sepsis, Disseminated Intravascular Coagulation, Hypotension, Dementia, Urinary Tract Infection, Hyponatraemia, Muscle Spasms

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Baclofen

Other drugs received by patient: Aricept Tablets, Sodium Chloride



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 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 female

Reported by a physician from United States on 2012-06-19

Patient: female

Reactions: Drug Withdrawal Syndrome, Muscle Spasms

Adverse event resulted in: death

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: Pain in Extremity, Implant Site Pain, Headache, Muscle Tightness, Gastric Disorder, Speech Disorder, Incision Site Complication, Dizziness, Sarcoidosis, Muscle Spasms

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: female

Reactions: Pain in Extremity, Implant Site Pain, Hypotension, Headache, Implant Site Mass, Speech Disorder, Incision Site Complication, Dizziness, Sarcoidosis, Muscle Spasms, Infusion Site Mass

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in 20 year old female

Reported by a physician from United States on 2012-05-30

Patient: 20 year old female

Reactions: Medical Device Complication, Post Lumbar Puncture Syndrome, Fatigue, Drug Effect Decreased, Diarrhoea, Pyrexia, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Muscle Spasticity

Baclofen
    Indication: Cerebral Palsy



Possible Baclofen side effects in 46 year old female

Reported by a physician from Japan on 2012-05-30

Patient: 46 year old female

Reactions: Postoperative Ileus, Drug Ineffective, Adhesion, Muscle Spasms

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in 64 year old female

Reported by a physician from United States on 2012-05-25

Patient: 64 year old female

Reactions: Multi-Organ Failure, Pupillary Reflex Impaired, Autonomic Nervous System Imbalance, Unresponsive To Stimuli, Incorrect Dose Administered, Toxicity To Various Agents, Muscle Spasms

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: male

Reactions: Burning Sensation, Implant Site Effusion, Device Dislocation, Muscle Spasms, Feeling Cold, Device Breakage

Drug(s) suspected as cause:
Baclofen
    Dosage: 99.92 mcg/day
    Indication: Cerebral Palsy

Baclofen
    Dosage: 99.92 mcg/day
    Indication: Muscle Spasticity



Possible Baclofen side effects in male

Reported by a physician from United Kingdom on 2012-05-15

Patient: male

Reactions: Nightmare, Paranoia, Drug Withdrawal Syndrome, Photopsia, Somnolence, Suicidal Ideation, Vision Blurred, Muscle Spasms

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in 20 year old female

Reported by a physician from United States on 2012-05-15

Patient: 20 year old female

Reactions: Medical Device Complication, Bloody Discharge, Implant Site Discharge, Implant Site Effusion, Pyrexia, Implant Site Swelling, Therapeutic Response Decreased, Fatigue, Post Lumbar Puncture Syndrome, Diarrhoea, Open Wound, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Muscle Spasticity

Baclofen
    Indication: Cerebral Palsy



Possible Baclofen side effects in 29 year old male

Reported by a physician from Japan on 2012-05-15

Patient: 29 year old male

Reactions: Peripheral Coldness, Disseminated Intravascular Coagulation, Blood Albumin Decreased, Blood Calcium Increased, Pyrexia, Platelet Distribution Width Increased, Activated Partial Thromboplastin Time Prolonged, Haematocrit Decreased, Blood Sodium Decreased, Drug Therapy Changed, Muscle Spasms, Vomiting, Blood Urea Increased, Blood Chloride Decreased, Blood Lactate Dehydrogenase Increased, International Normalised Ratio Increased, Alanine Aminotransferase Increased, Protein Total Decreased, Mean Platelet Volume Increased, Drug Withdrawal Syndrome, Haemoglobin Decreased, Serratia Sepsis, Aspartate Aminotransferase Increased, Septic Shock, Complex Partial Seizures

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baclofen

Other drugs received by patient: Horizon 10; Platelets; Futhan



Possible Baclofen side effects in 20 year old female

Reported by a physician from United States on 2012-05-14

Patient: 20 year old female

Reactions: Drug Effect Decreased, Device Kink, Implant Site Effusion, Pyrexia, Device Occlusion, Device Dislocation, Fatigue, Post Lumbar Puncture Syndrome, Diarrhoea, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Cerebral Palsy

Baclofen
    Indication: Muscle Spasticity



Possible Baclofen side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-14

Patient: female

Reactions: Pain in Extremity, Hypotension, Condition Aggravated, Headache, Granuloma, Muscle Tightness, Speech Disorder, Implant Site Reaction, Dizziness, Sarcoidosis, Muscle Spasms

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-14

Patient: female

Reactions: Speech Disorder, Pain in Extremity, Dizziness, Muscle Tightness, Granuloma, Muscle Spasms

Drug(s) suspected as cause:
Baclofen



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