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 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 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 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 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 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 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 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 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 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 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 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 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
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
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 56 year old female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 56 year old female, weighing 68.0 kg (149.6 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Hallucination, Visual, Ankle Fracture
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Amantadine HCL
Indication: Product Used FOR Unknown Indication
Ampyra
Dosage: 10 mg, bid, oral
Administration route: Oral
Indication: Gait Disturbance
Start date: 2011-01-01
Baclofen
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Vitamins NOS (Vitamins Nos); Iron (Iron)
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: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Baclofen
Indication: Autonomic Nervous System Imbalance
Baclofen
Indication: Craniocerebral Injury
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