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Baclofen Side Effects

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Common Baclofen Side Effects


The most commonly reported Baclofen side effects (click to view or check a box to report):

Overdose (180)
Coma (125)
Muscle Spasticity (122)
Pain (99)
Confusional State (94)
Muscle Spasms (94)
Completed Suicide (92)
Convulsion (92)
Fatigue (81)
Fall (77)
Somnolence (76)
Pyrexia (75)
Nausea (73)
Hypertension (73)
Dizziness (71)
Headache (70)
Death (70)
Vomiting (69)
Mental Status Changes (68)
Poisoning (68)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Baclofen Side Effects Reported to FDA



Baclofen Side Effect Report#9913494
Overdose, Hypertriglyceridaemia, Treatment Noncompliance, Mania, Blood Cholesterol Increased, Hyponatraemia, Weight Increased
This is a report of a 39-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: alcoholism,bipolar disorder, who was treated with Baclofen (dosage: NA, start time: NS), combined with:
  • Risperidone (risperidone) (During Week 1)
  • Lithium
and developed a serious reaction and side effect(s): Overdose, Hypertriglyceridaemia, Treatment Noncompliance, Mania, Blood Cholesterol Increased, Hyponatraemia, Weight Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in male patients, resulting in Overdose side effect.
Baclofen Side Effect Report#9913133
Radiculopathy, Csf Protein Increased, Csf Glucose Decreased, Aspergillus Infection, Device Related Infection
This report suggests a potential Baclofen Radiculopathy side effect(s) that can have serious consequences. A 39-year-old male patient (weight: NA) from AU was diagnosed with the following symptoms/conditions: muscle spasticity and used Baclofen (dosage: NA) starting 201101. After starting Baclofen the patient began experiencing various side effects, including: Radiculopathy, Csf Protein Increased, Csf Glucose Decreased, Aspergillus Infection, Device Related InfectionAdditional drugs used concurrently: NA.The patient was hospitalized and became disabled. Although Baclofen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Radiculopathy, may still occur.
Baclofen Side Effect Report#9913130
Haemodialysis, Toxic Encephalopathy, Haemoglobin Decreased, White Blood Cell Count Increased, Blood Potassium Decreased, Blood Chloride Decreased, Blood Bilirubin Increased, Po2 Decreased, Oxygen Saturation Decreased
This Haemodialysis problem was reported by a consumer or non-health professional from US. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hiccups. On NS this consumer started treatment with Baclofen (dosage: NA). The following drugs were being taken at the same time: NA. When using Baclofen, the patient experienced the following unwanted symptoms/side effects: Haemodialysis, Toxic Encephalopathy, Haemoglobin Decreased, White Blood Cell Count Increased, Blood Potassium Decreased, Blood Chloride Decreased, Blood Bilirubin Increased, Po2 Decreased, Oxygen Saturation DecreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemodialysis, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9913124
Platelet Count Increased, Blood Potassium Decreased, Blood Chloride Decreased, Blood Magnesium Increased, Toxic Encephalopathy
This Platelet Count Increased side effect was reported by a physician from KR. A 35-year-old female patient (weight:NA) experienced the following symptoms/conditions: rib fracture,hiccups.The patient was prescribed Baclofen (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Baclofen the consumer reported adverse symptoms, such as: Platelet Count Increased, Blood Potassium Decreased, Blood Chloride Decreased, Blood Magnesium Increased, Toxic EncephalopathyThese side effects may potentially be related to Baclofen. The patient was hospitalized.
Baclofen Side Effect Report#9913108
Agitation, Muscle Contractions Involuntary, Respiratory Acidosis, Rhonchi, Tachypnoea, Encephalopathy, Toxicity To Various Agents
This is a report of a 58-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Baclofen (dosage: NA, start time: NS), combined with:
  • Bisoprolol
  • Atorvastatin
  • Escitalopram
  • Acamprosate
  • Naltrexone
and developed a serious reaction and side effect(s): Agitation, Muscle Contractions Involuntary, Respiratory Acidosis, Rhonchi, Tachypnoea, Encephalopathy, Toxicity To Various Agents after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in male patients, resulting in Agitation side effect. The patient was hospitalized.
Baclofen Side Effect Report#9912828
Overdose, Blood Triglycerides Increased, Treatment Noncompliance, Blood Cholesterol Increased, Hyponatraemia, Weight Increased
This report suggests a potential Baclofen Overdose side effect(s) that can have serious consequences. A 39-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: alcoholism,bipolar disorder and used Baclofen (dosage: 20 Mg, Per Day) starting NS. After starting Baclofen the patient began experiencing various side effects, including: Overdose, Blood Triglycerides Increased, Treatment Noncompliance, Blood Cholesterol Increased, Hyponatraemia, Weight IncreasedAdditional drugs used concurrently:
  • Risperidone (1 Mg, Per Day During Week 1)
  • Lithium
Although Baclofen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Overdose, may still occur.
Baclofen Side Effect Report#9912814
Mental Impairment, Haemoglobin Decreased, White Blood Cell Count Increased, Blood Potassium Decreased, Blood Bilirubin Increased, Haemodialysis, Toxic Encephalopathy, Po2 Decreased, Oxygen Saturation Decreased
This Mental Impairment problem was reported by a consumer or non-health professional from KR. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hiccups. On NS this consumer started treatment with Baclofen (dosage: NA). The following drugs were being taken at the same time: NA. When using Baclofen, the patient experienced the following unwanted symptoms/side effects: Mental Impairment, Haemoglobin Decreased, White Blood Cell Count Increased, Blood Potassium Decreased, Blood Bilirubin Increased, Haemodialysis, Toxic Encephalopathy, Po2 Decreased, Oxygen Saturation DecreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Mental Impairment, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9912656
Muscular Weakness, Pain In Extremity, Wheelchair User, Hypertonia, Nuclear Magnetic Resonance Imaging Spinal Abnormal, Muscle Contractions Involuntary, Muscle Contractions Involuntary, Radiculopathy, Csf Protein Increased
This Muscular Weakness side effect was reported by a health professional from AU. A 39-year-old male patient (weight:NA) experienced the following symptoms/conditions: progressive multiple sclerosis.The patient was prescribed Baclofen (drug dosage: ([pump Intrathecal), ((pump, Alteration In Dosage] Df Intrathecal)), which was initiated on 201101. Concurrently used drugs: NA..After starting to take Baclofen the consumer reported adverse symptoms, such as: Muscular Weakness, Pain In Extremity, Wheelchair User, Hypertonia, Nuclear Magnetic Resonance Imaging Spinal Abnormal, Muscle Contractions Involuntary, Muscle Contractions Involuntary, Radiculopathy, Csf Protein IncreasedThese side effects may potentially be related to Baclofen. The patient was hospitalized and became disabled.
Baclofen Side Effect Report#9912560
Mental Impairment, Platelet Count Increased, Blood Potassium Decreased, Blood Chloride Decreased, Blood Magnesium Increased, Toxic Encephalopathy
This is a report of a 35-year-old female patient (weight: NA) from KR, suffering from the following health symptoms/conditions: rib fracture,hiccups, who was treated with Baclofen (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Mental Impairment, Platelet Count Increased, Blood Potassium Decreased, Blood Chloride Decreased, Blood Magnesium Increased, Toxic Encephalopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in female patients, resulting in Mental Impairment side effect. The patient was hospitalized.
Baclofen Side Effect Report#9908920
Depressed Level Of Consciousness, Agitation, Confusional State, Altered State Of Consciousness, Nervous System Disorder, Muscle Contractions Involuntary, Rhonchi, Respiratory Acidosis, Brain Natriuretic Peptide Increased
This report suggests a potential Baclofen Depressed Level Of Consciousness side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Baclofen (dosage: NA) starting NS. After starting Baclofen the patient began experiencing various side effects, including: Depressed Level Of Consciousness, Agitation, Confusional State, Altered State Of Consciousness, Nervous System Disorder, Muscle Contractions Involuntary, Rhonchi, Respiratory Acidosis, Brain Natriuretic Peptide IncreasedAdditional drugs used concurrently:
  • Bisoprolol
  • Atorvastatin
  • Escitalopram
  • Acamprosate
  • Naltrexone
The patient was hospitalized. Although Baclofen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Depressed Level Of Consciousness, may still occur.
Baclofen Side Effect Report#9908311
Encephalopathy, Parkinsonism, Condition Aggravated, Confusional State, Muscle Rigidity
This Encephalopathy problem was reported by a pharmacist from US. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bipolar disorder. On NS this consumer started treatment with Baclofen (dosage: Recent). The following drugs were being taken at the same time:
  • Carvedilol
  • Simvastatin
  • Docusate
  • Lasix
  • Depakote
  • Ferrous Sulfate
  • Zantac
  • Ecasa
When using Baclofen, the patient experienced the following unwanted symptoms/side effects: Encephalopathy, Parkinsonism, Condition Aggravated, Confusional State, Muscle RigidityThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Encephalopathy, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9901219
Dyskinesia
This Dyskinesia side effect was reported by a physician from GB. A 82-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Baclofen (drug dosage: NA), which was initiated on
Dec 06, 2013. Concurrently used drugs:
  • Aspirin
  • Atenolol
  • Madopar
  • Pramipexole
  • Pravastatin
  • Ramipril
  • Stalevo
  • Clonazepam
.After starting to take Baclofen the consumer reported adverse symptoms, such as: DyskinesiaThese side effects may potentially be related to Baclofen. The patient was hospitalized and became disabled.
Baclofen Side Effect Report#9899301
Dyskinesia
This is a report of a 82-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Baclofen (dosage: NA, start time:
Jan 04, 2012), combined with:
  • Amoxicillin
  • Aspirin
  • Atenolol
  • Clonazepam
  • Domperidone
  • Folic Acid
  • Hyoscine Hydrobromide
  • Madopar
and developed a serious reaction and side effect(s): Dyskinesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in male patients, resulting in Dyskinesia side effect. The patient was hospitalized and became disabled.
Baclofen Side Effect Report#9891591
Fatigue, Pain, Fall, Clavicle Fracture
This report suggests a potential Baclofen Intrathecal Fatigue side effect(s) that can have serious consequences. A 42-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: head injury and used Baclofen Intrathecal (dosage: NA) starting NS. After starting Baclofen Intrathecal the patient began experiencing various side effects, including: Fatigue, Pain, Fall, Clavicle FractureAdditional drugs used concurrently: NA. Although Baclofen Intrathecal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fatigue, may still occur.
Baclofen Side Effect Report#9891265
Syncope
This Syncope problem was reported by a pharmacist from US. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: muscle spasticity. On
Jan 15, 2013 this consumer started treatment with Baclofen (dosage: NA). The following drugs were being taken at the same time: NA. When using Baclofen, the patient experienced the following unwanted symptoms/side effects: SyncopeThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Syncope, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9890981
Diabetes Mellitus, Vomiting, Confusional State, Dehydration, Hyperthermia, Blood Potassium Decreased, White Blood Cell Count Increased, C-reactive Protein Increased, Agitation
This Diabetes Mellitus side effect was reported by a physician from FR. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: alcohol use.The patient was prescribed Baclofen (drug dosage: 120 Mg/day), which was initiated on NS. Concurrently used drugs:
  • Alcohol (ethanol) (10 Drinks/day)
.After starting to take Baclofen the consumer reported adverse symptoms, such as: Diabetes Mellitus, Vomiting, Confusional State, Dehydration, Hyperthermia, Blood Potassium Decreased, White Blood Cell Count Increased, C-reactive Protein Increased, AgitationThese side effects may potentially be related to Baclofen. The patient was hospitalized.
Baclofen Side Effect Report#9890974
Confusional State, Hallucination, Visual, Hyperhidrosis, Tremor, Blood Pressure Increased, Sinus Tachycardia, Leukocytosis, Neutrophilia, Hepatocellular Injury
This is a report of a 35-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: alcohol use, who was treated with Baclofen (dosage: 240 Mg/day, start time: NS), combined with:
  • Alcohol (ethanol)
  • Alprazolam (2mg/day)
  • Escitalopram (20mg/day)
  • Amitriptyline (75mg/day)
  • Cannabis
and developed a serious reaction and side effect(s): Confusional State, Hallucination, Visual, Hyperhidrosis, Tremor, Blood Pressure Increased, Sinus Tachycardia, Leukocytosis, Neutrophilia, Hepatocellular Injury after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in male patients, resulting in Confusional State side effect.
Baclofen Side Effect Report#9890965
Suicide Attempt, Lactic Acidosis, Hypoxia, Confusional State, Delirium, Rhabdomyolysis, Alcohol Withdrawal Syndrome, Nervous System Disorder
This report suggests a potential Baclofen Suicide Attempt side effect(s) that can have serious consequences. A 35-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: alcohol use and used Baclofen (dosage: 210 Mg/day) starting NS. After starting Baclofen the patient began experiencing various side effects, including: Suicide Attempt, Lactic Acidosis, Hypoxia, Confusional State, Delirium, Rhabdomyolysis, Alcohol Withdrawal Syndrome, Nervous System DisorderAdditional drugs used concurrently:
  • Alcohol (ethanol)
Although Baclofen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicide Attempt, may still occur.
Baclofen Side Effect Report#9890458
Dyskinesia
This Dyskinesia problem was reported by a health professional from GB. A 82-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 04, 2012 this consumer started treatment with Baclofen (dosage: Unk). The following drugs were being taken at the same time:
  • Amoxicillin (Unk)
  • Aspirin (Unk)
  • Atenolol (Unk)
  • Clonazepam (Unk)
  • Domperidone (Unk)
  • Folic Acid (Unk)
  • Hyoscine Hydrobromide (Unk)
  • Madopar (Unk)
When using Baclofen, the patient experienced the following unwanted symptoms/side effects: DyskinesiaThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyskinesia, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9879150
Euphoric Mood, Memory Impairment, Hypothermia, Delirium, Red Blood Cell Count Decreased, Emotional Distress, Tracheal Haemorrhage, Adverse Event, Blood Pressure Increased
This Euphoric Mood side effect was reported by a consumer or non-health professional from US. A 62-year-old male patient (weight:NA) experienced the following symptoms/conditions: cerebral palsy.The patient was prescribed Baclofen Intrathecal (drug dosage: Unk Ukn, Unk), which was initiated on 201402. Concurrently used drugs: NA..After starting to take Baclofen Intrathecal the consumer reported adverse symptoms, such as: Euphoric Mood, Memory Impairment, Hypothermia, Delirium, Red Blood Cell Count Decreased, Emotional Distress, Tracheal Haemorrhage, Adverse Event, Blood Pressure IncreasedThese side effects may potentially be related to Baclofen Intrathecal.
Baclofen Side Effect Report#9874354
Visual Impairment, Gait Disturbance, Tremor, Dizziness
This is a report of a 38-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Baclofen (dosage: Unk, start time:
Feb 13, 2013), combined with:
  • Flomax (Unk)
  • Tamsulosin Hydrochloride (0.4 Mg, Unk)
  • Ampyra (10 Mg, Bid)
and developed a serious reaction and side effect(s): Visual Impairment, Gait Disturbance, Tremor, Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in male patients, resulting in Visual Impairment side effect.
Baclofen Side Effect Report#9870832
Poisoning, Completed Suicide, Unresponsive To Stimuli, Tremor, Incorrect Dose Administered, Blood Pressure Systolic Increased, Grand Mal Convulsion, Hypotension, Intentional Overdose
This report suggests a potential Baclofen Poisoning side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Baclofen (dosage: NA) starting 2012. After starting Baclofen the patient began experiencing various side effects, including: Poisoning, Completed Suicide, Unresponsive To Stimuli, Tremor, Incorrect Dose Administered, Blood Pressure Systolic Increased, Grand Mal Convulsion, Hypotension, Intentional OverdoseAdditional drugs used concurrently: NA.The patient was hospitalized. Although Baclofen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning, may still occur.
Baclofen Side Effect Report#9870685
Grand Mal Convulsion, Hypotension
This Grand Mal Convulsion problem was reported by a pharmacist from US. A 57-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2012 this consumer started treatment with Baclofen (dosage: Not The Prescribed Dose). The following drugs were being taken at the same time: NA. When using Baclofen, the patient experienced the following unwanted symptoms/side effects: Grand Mal Convulsion, HypotensionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Grand Mal Convulsion, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9870676
Completed Suicide
This Completed Suicide side effect was reported by a health professional from US. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Baclofen (drug dosage: Df), which was initiated on NS. Concurrently used drugs: NA..After starting to take Baclofen the consumer reported adverse symptoms, such as: Completed SuicideThese side effects may potentially be related to Baclofen.
Baclofen Side Effect Report#9870668
Poisoning, Exposure Via Ingestion, Completed Suicide
This is a report of a 45-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Baclofen (dosage: Df Oral, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Poisoning, Exposure Via Ingestion, Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in female patients, resulting in Poisoning side effect.


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The appearance of Baclofen on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Baclofen Side Effects for Women?

Women Side EffectsReports
Overdose 87
Coma 75
Completed Suicide 66
Fatigue 56
Pain 55
Convulsion 48
Poisoning 46
Fall 45
Muscle Spasms 45
Pneumonia 45

What are common Baclofen Side Effects for Men?

Men Side EffectsReports
Overdose 92
Muscle Spasticity 80
Confusional State 56
Coma 50
Mental Status Changes 49
Muscle Spasms 48
Convulsion 44
Hypotension 44
Agitation 41
Pain 41

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Baclofen reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Baclofen Safety Alerts, Active Ingredients, Usage Information

    NDC0172-4096
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameBaclofen
    NameBaclofen
    Dosage FormTABLET
    RouteORAL
    On market since19880721
    LabelerIVAX Pharmaceuticals, Inc.
    Active Ingredient(s)BACLOFEN
    Strength(s)10
    Unit(s)mg/1
    Pharma ClassGABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]

    Baclofen Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2241

    Baclofen safety alerts: 2002

    Reported deaths: 304

    Reported hospitalizations: 1029

    Latest Baclofen clinical trials