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Baclofen (Baclofen) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Baclofen and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (920)
Death (232)
Life Threatening Events (64)
Disability (16)

Reports by Reaction Type

Overdose (86)Coma (65)Muscle Spasms (61)Neurotoxicity (59)Vomiting (52)Death (50)Completed Suicide (50)Muscle Spasticity (48)Dizziness (45)Convulsion (45)Condition Aggravated (42)Drug Withdrawal Syndrome (42)

Below are a few examples of reports where side effects / adverse reactions may be related to Baclofen. For a complete list or a specific selection of reports, please use the links above.

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 female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female, weighing 65.8 kg (144.7 pounds)

Reactions: Confusional State, Vomiting Projectile, Pain, Abasia, Parinaud Syndrome, Chills, Pyrexia, Pneumothorax, Adverse Event, Injury, Eye Disorder, Hypersomnia, Pneumonia, Pain in Extremity, Stress, Anxiety, Mental Impairment, Insomnia, Sensory Disturbance, Presyncope, Disability, Inflammation

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Baclofen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2011-01-01

Duragesic-100
    Dosage: 25 ug/hr+12.5 ug/hr
    Start date: 2012-05-01
    End date: 2012-07-01

Duragesic-100
    Start date: 2012-07-01
    End date: 2012-01-01

Duragesic-100
    Start date: 2012-01-01
    End date: 2012-01-01

Duragesic-100
    Start date: 2009-01-01
    End date: 2011-08-01

Duragesic-100
    Indication: Back Injury
    Start date: 2011-08-01
    End date: 2012-05-01

Duragesic-100
    Start date: 2012-01-01

Effexor
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-06-01
    End date: 2012-06-01



Possible Baclofen side effects in 79 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-21

Patient: 79 year old male

Reactions: Palpitations, Dizziness, Posture Abnormal, Somnolence

Drug(s) suspected as cause:
Baclofen

Other drugs received by patient: Finasteride



Possible Baclofen side effects in 63 year old female

Reported by a pharmacist from Germany on 2012-08-21

Patient: 63 year old female

Reactions: Asthma, Loss of Consciousness

Drug(s) suspected as cause:
Baclofen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-01

Fentanyl
    Indication: Product Used FOR Unknown Indication

Pregabalin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Baclofen side effects in 50 year old female

Reported by a physician from United Kingdom on 2012-08-20

Patient: 50 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Hypermobility Syndrome, Pain in Extremity, Paraesthesia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Baclofen
    Administration route: Oral
    Start date: 2012-01-01

Baclofen
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-07-14

Baclofen
    Dosage: 30 milligram daily;
    Administration route: Oral
    Indication: Alcoholism
    Start date: 2011-12-01

Other drugs received by patient: Lamotrigine



Possible Baclofen side effects in 62 year old female

Reported by a pharmacist from Germany on 2012-08-16

Patient: 62 year old female

Reactions: Asthma

Drug(s) suspected as cause:
Baclofen
    Dosage: unk
    Indication: Back Pain
    Start date: 2012-05-01

Fentanyl
    Dosage: 75 mg, every 3 days
    Start date: 2010-01-01

Lyrica
    Dosage: unk
    Indication: Back Pain
    Start date: 2010-01-01



Possible Baclofen side effects in 7 year old male

Reported by a physician from Japan on 2012-08-10

Patient: 7 year old male

Reactions: Drug Ineffective, Urinary Tract Infection, Meningitis Bacterial

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-10

Patient: 36 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Amitriptyline HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Baclofen
    Indication: Product Used FOR Unknown Indication
    End date: 2011-12-09

Botulinum Toxin Type B
    Indication: Dystonia
    Start date: 2009-06-04

Clonazepam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Pregabalin

Pregabalin
    Administration route: Oral
    Indication: Pain
    Start date: 2011-12-03
    End date: 2011-12-09



Possible Baclofen side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Back Pain, Drug Effect Decreased, Implant Site Pain, Muscular Weakness, Implant Site Swelling

Drug(s) suspected as cause:
Baclofen
    Indication: Pain

Baclofen
    Indication: Post Laminectomy Syndrome

Other drugs received by patient: Morphine; Bupivacaine; SEE B5



Possible Baclofen side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-09

Patient: 36 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Amitriptyline HCL
    Dosage: taken at night time
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Baclofen
    Indication: Product Used FOR Unknown Indication
    End date: 2011-12-09

Clonazepam
    Dosage: night time
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Neurobloc
    Indication: Dystonia
    Start date: 2009-06-04

Pregabalin
    Administration route: Oral
    Indication: Pain
    Start date: 2011-12-03
    End date: 2011-12-09



Possible Baclofen side effects in male

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

Patient: male

Reactions: Haematochezia, Vomiting, Nausea, Pain, Drug Withdrawal Syndrome, Fall, Hypertension, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen

Other drugs received by patient: Fentanyl; Bupivacaine HCL



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 36 year old female

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

Patient: 36 year old female

Reactions: Abortion Spontaneous

Drug(s) suspected as cause:
Amitriptyline HCL
    Dosage: 25 mg, 1x/day
    Administration route: Oral

Baclofen
    Dosage: 5 mg, 3x/day
    End date: 2011-12-09

Clonazepam
    Dosage: 2 mg, 1x/day
    Administration route: Oral

Neurobloc
    Dosage: 10000 iu every 16 weeks
    Indication: Dystonia
    Start date: 2009-06-04

Pregabalin
    Dosage: 150 mg, 2x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-12-03
    End date: 2011-12-09



Possible Baclofen side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 47 year old male

Reactions: Drug Diversion, Tachycardia, Intentional Drug Misuse

Drug(s) suspected as cause:
Baclofen
    Dosage: 20 mg, unk
    Administration route: Oral
    Start date: 2012-06-24
    End date: 2012-06-24

Exalgo
    Dosage: 2 - 16 mg, 36 mg total
    Administration route: Oral
    Start date: 2012-06-24
    End date: 2012-06-24

Tizanidine Hydrochloride
    Dosage: 15 mg, 26 pills ingested, 390 mg total
    Administration route: Oral
    Start date: 2012-06-24
    End date: 2012-06-24



Possible Baclofen side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-06

Patient: 36 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Amitriptyline HCL
    Dosage: 25 mg, qd
    Administration route: Oral

Baclofen
    Dosage: 5 mg, tid
    Administration route: Oral
    End date: 2011-12-09

Clonazepam
    Dosage: 2 mg, qd
    Administration route: Oral

Neurobloc
    Dosage: 10000 iu, for every 16 weeks
    Indication: Dystonia
    Start date: 2009-06-04

Pregabalin
    Dosage: 150 mg, bid
    Administration route: Oral
    Indication: Pain
    Start date: 2011-12-03
    End date: 2011-12-09



Possible Baclofen side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: 58 year old female, weighing 81.6 kg (179.6 pounds)

Reactions: Weight Decreased, Nightmare, Muscular Weakness, Oropharyngeal Pain, Headache, Mental Impairment, Incontinence, Activities of Daily Living Impaired, Mood Altered, Fear of Falling, Vision Blurred, Crying, Cough

Drug(s) suspected as cause:
Baclofen

Other drugs received by patient: Lisinopril; Simvastatin; Fluticasone Propionate; Clonazepam; Combivent; Aspirin; Albuterol; Sertraline Hydrochloride



Possible Baclofen side effects in male

Reported by a physician from United States on 2012-08-06

Patient: male

Reactions: Wound, Pulse Absent, Toxicity To Various Agents, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Spinal Cord Disorder

Baclofen
    Dosage: 480.2 ug, daily
    Indication: Spinal Cord Injury

Methadon Hydrochloride TAB

Other drugs received by patient: Aspirin; Docusate; Alprazolam



Possible Baclofen side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-05

Patient: female

Reactions: Hyponatraemia, Headache, Fall, Convulsion, Grand MAL Convulsion, Mental Impairment, Neck Pain, RIB Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen
    Dosage: 285.3 mcg/day
    Indication: Muscle Spasticity

Baclofen
    Dosage: 285.3 mcg/day
    Indication: Multiple Sclerosis

Other drugs received by patient: Bupivacaine HCL; Fentanyl



Possible Baclofen side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-05

Patient: female

Reactions: Weight Bearing Difficulty, Arthralgia

Drug(s) suspected as cause:
Baclofen



Possible Baclofen side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-04

Patient:

Reactions: Dyspepsia, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Baclofen

Betaseron

Imitrex

Meloxicam

Oxybutynin

Prilosec
    Administration route: Oral

Testim

Tizanidine Hydrochloride

Wellbutrin XL

Zocor
    Administration route: Oral



Possible Baclofen side effects in male

Reported by a physician from United States on 2012-08-03

Patient: male

Reactions: Accidental Poisoning, Pulse Absent, Toxicity To Various Agents, Cardiac Arrest, Drug Abuse

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Baclofen
    Dosage: 480.2 m0g/day
    Indication: Spinal Cord Injury

Baclofen
    Dosage: 480.2 m0g/day
    Indication: Spinal Cord Disorder

Other drugs received by patient: Alprazolam; Aspirin; Docusate



Possible Baclofen side effects in male

Reported by a physician from Japan on 2012-08-03

Patient: male

Reactions: Drug Ineffective, Urinary Tract Infection, Meningitis Bacterial, Asthenia

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 2012-08-03

Patient: female

Reactions: Back Pain, Application Site Anaesthesia, Drug Effect Decreased, Nausea, Pain, Device Leakage, Dysgeusia, Device Failure, Malaise, Parosmia, Feeling Abnormal, Neuralgia

Drug(s) suspected as cause:
Baclofen

Other drugs received by patient: Bupivacaine HCL; Morphine



Possible Baclofen side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 65 year old male

Reactions: Chest Pain, Encephalopathy, Renal Failure Acute, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen

Insulin Human
    Indication: Type 2 Diabetes Mellitus

Lantus
    Indication: Type 2 Diabetes Mellitus

Placebo
    Start date: 2012-06-01

Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-11
    End date: 2011-04-02

Saxagliptin
    Start date: 2012-06-01

Saxagliptin
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-11
    End date: 2011-04-02

Other drugs received by patient: Hydrochlorothiazide; Lisinopril; Aspirin



Possible Baclofen side effects in 43 year old male

Reported by a physician from France on 2012-08-02

Patient: 43 year old male

Reactions: Anxiety, Completed Suicide, Condition Aggravated, Depression

Adverse event resulted in: death

Drug(s) suspected as cause:
Baclofen
    Administration route: Oral

Baclofen
    Administration route: Oral
    Start date: 2010-04-01

Seroquel
    Administration route: Oral
    Start date: 2011-12-01

Valdoxan
    Administration route: Oral
    Start date: 2011-12-01

Other drugs received by patient: Xanax; Buprenorphin



Possible Baclofen side effects in

Reported by a physician from France on 2012-08-01

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Baclofen
    Indication: Autonomic Nervous System Imbalance

Baclofen
    Indication: Craniocerebral Injury



Possible Baclofen side effects in

Reported by a physician from France on 2012-08-01

Patient:

Reactions: Altered State of Consciousness

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Baclofen
    Indication: Autonomic Nervous System Imbalance

Baclofen
    Indication: Craniocerebral Injury



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

Reported by a physician from France on 2012-08-01

Patient:

Reactions: Unresponsive To Stimuli

Adverse event resulted in: death

Drug(s) suspected as cause:
Baclofen
    Indication: Craniocerebral Injury

Baclofen
    Indication: Autonomic Nervous System Imbalance



Possible Baclofen side effects in

Reported by a physician from France on 2012-08-01

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Baclofen
    Indication: Craniocerebral Injury

Baclofen
    Indication: Autonomic Nervous System Imbalance

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