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)

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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#9995828
Loss Of Consciousness, Somnolence
This is a report of a 52-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Baclofen (dosage: NA, start time: NS), combined with:
  • Gabapentin
and developed a serious reaction and side effect(s): Loss Of Consciousness, Somnolence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in male patients, resulting in Loss Of Consciousness side effect. The patient was hospitalized.
Baclofen Side Effect Report#9993378
Meningitis Bacterial, Coma, Confusional State, Electroencephalogram Abnormal, Encephalopathy, Hypertension, Hypotension, Trismus, Muscle Spasms
This report suggests a potential Baclofen Meningitis Bacterial side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: tetanus,muscle spasms and used Baclofen (dosage: 20 Mg, Tid) starting NS. After starting Baclofen the patient began experiencing various side effects, including: Meningitis Bacterial, Coma, Confusional State, Electroencephalogram Abnormal, Encephalopathy, Hypertension, Hypotension, Trismus, Muscle SpasmsAdditional drugs used concurrently: NA.The patient was hospitalized. Although Baclofen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Meningitis Bacterial, may still occur.
Baclofen Side Effect Report#9989754
No Therapeutic Response, Pain, Back Pain, Lethargy, Insomnia, Memory Impairment, Breakthrough Pain
This No Therapeutic Response problem was reported by a consumer or non-health professional from US. A 52-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. 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: No Therapeutic Response, Pain, Back Pain, Lethargy, Insomnia, Memory Impairment, Breakthrough PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as No Therapeutic Response, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9989629
Convulsion
This Convulsion side effect was reported by a pharmacist from US. A 48-year-old male patient (weight:NA) experienced the following symptoms/conditions: convulsion.The patient was prescribed Baclofen (drug dosage: NA), which was initiated on
Sep 10, 2013. Concurrently used drugs:
  • Keppra
  • Eraxis
  • Xanax
  • Cymbalta
.After starting to take Baclofen the consumer reported adverse symptoms, such as: ConvulsionThese side effects may potentially be related to Baclofen. The patient was hospitalized.
Baclofen Side Effect Report#9988797
Respiratory Arrest, Device Failure, Overdose, Respiratory Failure, Pain
This is a report of a 60-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: muscle spasticity, who was treated with Baclofen (dosage: NA, start time: NS), combined with:
  • Morphine
  • Bupivacaine
  • Clonidine
and developed a serious reaction and side effect(s): Respiratory Arrest, Device Failure, Overdose, Respiratory Failure, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in male patients, resulting in Respiratory Arrest side effect. The patient was hospitalized.
Baclofen Side Effect Report#9988715
Feeling Cold, Feeling Hot, Sudden Onset Of Sleep, Overdose, Local Swelling, Local Swelling, Pain, Muscle Spasms
This report suggests a potential Baclofen Intrathecal Feeling Cold side effect(s) that can have serious consequences. A 47-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Baclofen Intrathecal (dosage: NA) starting NS. After starting Baclofen Intrathecal the patient began experiencing various side effects, including: Feeling Cold, Feeling Hot, Sudden Onset Of Sleep, Overdose, Local Swelling, Local Swelling, Pain, Muscle SpasmsAdditional drugs used concurrently:
  • Dilaudid (hydromorphone)
  • Bupivacaine Intrathecal
Although Baclofen Intrathecal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Feeling Cold, may still occur.
Baclofen Side Effect Report#9981304
Withdrawal Syndrome, Pain, Medical Device Complication, Hyperhidrosis, Complex Regional Pain Syndrome, Condition Aggravated
This Withdrawal Syndrome problem was reported by a consumer or non-health professional from US. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On NS this consumer started treatment with Baclofen (dosage: NA). The following drugs were being taken at the same time:
  • Dilaudid
  • Clonidine
  • Bupivacaine
When using Baclofen, the patient experienced the following unwanted symptoms/side effects: Withdrawal Syndrome, Pain, Medical Device Complication, Hyperhidrosis, Complex Regional Pain Syndrome, Condition AggravatedThe 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 Withdrawal Syndrome, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9971515
Withdrawal Syndrome, Dystonia
This Withdrawal Syndrome side effect was reported by a consumer or non-health professional from US. A 60-year-old female patient (weight:NA) experienced the following symptoms/conditions: pain.The patient was prescribed Baclofen (drug dosage: See B5), which was initiated on NS. Concurrently used drugs:
  • Morphine (See B5)
  • Fentanyl (19.457 Mcg/day (concentration Not Specified))
.After starting to take Baclofen the consumer reported adverse symptoms, such as: Withdrawal Syndrome, DystoniaThese side effects may potentially be related to Baclofen.
Baclofen Side Effect Report#9970243
Coma, Hypertension, Agitation, Poisoning
This is a report of a 25-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: alcoholism, who was treated with Baclofen (dosage: NA, start time: NS), combined with:
  • Alcohol (ethanol)
and developed a serious reaction and side effect(s): Coma, Hypertension, Agitation, Poisoning after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in female patients, resulting in Coma side effect. The patient was hospitalized.
Baclofen Side Effect Report#9969997
Miosis, Depressed Level Of Consciousness
This report suggests a potential Baclofen Miosis side effect(s) that can have serious consequences. A 45-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: alcoholism,anxiety disorder and used Baclofen (dosage: NA) starting NS. After starting Baclofen the patient began experiencing various side effects, including: Miosis, Depressed Level Of ConsciousnessAdditional drugs used concurrently:
  • Diazepam
The patient was hospitalized. Although Baclofen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Miosis, may still occur.
Baclofen Side Effect Report#9969994
Hypertension, Mydriasis
This Hypertension problem was reported by a consumer or non-health professional from FR. A 25-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: alcoholism. On NS this consumer started treatment with Baclofen (dosage: Day). The following drugs were being taken at the same time: NA. When using Baclofen, the patient experienced the following unwanted symptoms/side effects: Hypertension, MydriasisThe 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 Hypertension, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9969985
Somnolence
This Somnolence side effect was reported by a consumer or non-health professional from FR. A 28-year-old female patient (weight:NA) experienced the following symptoms/conditions: alcoholism.The patient was prescribed Baclofen (drug dosage: Day), which was initiated on NS. Concurrently used drugs:
  • Alcohol (ethanol)
.After starting to take Baclofen the consumer reported adverse symptoms, such as: SomnolenceThese side effects may potentially be related to Baclofen. The patient was hospitalized.
Baclofen Side Effect Report#9969983
Somnolence, Overdose
This is a report of a 40-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: alcoholism, who was treated with Baclofen (dosage: Day, start time: NS), combined with:
  • Alcohol (ethanol)
and developed a serious reaction and side effect(s): Somnolence, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in female patients, resulting in Somnolence side effect. The patient was hospitalized.
Baclofen Side Effect Report#9969972
Somnolence, Miosis
This report suggests a potential Baclofen Somnolence side effect(s) that can have serious consequences. A 46-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: alcoholism and used Baclofen (dosage: NA) starting NS. After starting Baclofen the patient began experiencing various side effects, including: Somnolence, MiosisAdditional drugs used concurrently:
  • Benzodiazepines
The patient was hospitalized. Although Baclofen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Somnolence, may still occur.
Baclofen Side Effect Report#9964933
Urinary Tract Infection, Implant Site Pain, Muscle Spasms, Muscle Tightness, Musculoskeletal Stiffness, Therapeutic Response Decreased
This Urinary Tract Infection problem was reported by a consumer or non-health professional from US. A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: muscle spasms. On
Jul 28, 2009 this consumer started treatment with Baclofen Intrathecal (dosage: 357.4 Ug/day). The following drugs were being taken at the same time: NA. When using Baclofen Intrathecal, the patient experienced the following unwanted symptoms/side effects: Urinary Tract Infection, Implant Site Pain, Muscle Spasms, Muscle Tightness, Musculoskeletal Stiffness, Therapeutic Response DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Urinary Tract Infection, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9963968
Liver Function Test Abnormal, White Blood Cell Count Abnormal
This Liver Function Test Abnormal side effect was reported by a health professional from GB. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Baclofen (drug dosage: 5 Mg, Qid), which was initiated on 201311. Concurrently used drugs:
  • Lansoprazole (15 Mg, Qd In The Morning.)
  • Mirtazapine (45 Mg, Qd At Night.)
  • Mirtazapine (30 Mg, Qd At Night.)
.After starting to take Baclofen the consumer reported adverse symptoms, such as: Liver Function Test Abnormal, White Blood Cell Count AbnormalThese side effects may potentially be related to Baclofen. The patient was hospitalized.
Baclofen Side Effect Report#9960070
Skin Disorder
This is a report of a 16-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: muscle spasticity, who was treated with Baclofen Intrathecal (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Skin Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen Intrathecal treatment in male patients, resulting in Skin Disorder side effect.
Baclofen Side Effect Report#9959869
Electroencephalogram Abnormal, Coma, Autonomic Nervous System Imbalance, Hypotension, Hypertension, Tachycardia, Atrial Fibrillation, Meningitis, Encephalopathy
This report suggests a potential Baclofen Intrathecal Electroencephalogram Abnormal side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: tetanus and used Baclofen Intrathecal (dosage: See B.5) starting NS. After starting Baclofen Intrathecal the patient began experiencing various side effects, including: Electroencephalogram Abnormal, Coma, Autonomic Nervous System Imbalance, Hypotension, Hypertension, Tachycardia, Atrial Fibrillation, Meningitis, EncephalopathyAdditional drugs used concurrently: NA.The patient was hospitalized. Although Baclofen Intrathecal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Electroencephalogram Abnormal, may still occur.
Baclofen Side Effect Report#9959472
Urosepsis, Septic Shock, Disease Recurrence, Multiple Sclerosis, Terminal State
This Urosepsis problem was reported by a consumer or non-health professional from US. A 68-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: muscle spasticity. On NS this consumer started treatment with Baclofen Intrathecal (dosage: NA). The following drugs were being taken at the same time:
  • Bupivacaine Intrathecal
When using Baclofen Intrathecal, the patient experienced the following unwanted symptoms/side effects: Urosepsis, Septic Shock, Disease Recurrence, Multiple Sclerosis, Terminal StateAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Urosepsis, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9958696
Convulsion, Gastrointestinal Disorder
This Convulsion side effect was reported by a consumer or non-health professional from US. A 58-year-old male patient (weight:NA) experienced the following symptoms/conditions: muscle spasticity.The patient was prescribed Baclofen Intrathecal (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Baclofen Intrathecal the consumer reported adverse symptoms, such as: Convulsion, Gastrointestinal DisorderThese side effects may potentially be related to Baclofen Intrathecal. The patient was hospitalized.
Baclofen Side Effect Report#9958637
Implant Site Discharge, Wound Dehiscence, Cerebrospinal Fluid Leakage, Headache, Pain
This is a report of a 12-year-old patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Baclofen (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Implant Site Discharge, Wound Dehiscence, Cerebrospinal Fluid Leakage, Headache, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in patients, resulting in Implant Site Discharge side effect.
Baclofen Side Effect Report#9925106
Localised Infection, Erythema, Feeling Hot
This report suggests a potential Baclofen Intrathecal Localised Infection side effect(s) that can have serious consequences. A 74-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cerebrovascular accident and used Baclofen Intrathecal (dosage: 33 Or 31^) starting NS. After starting Baclofen Intrathecal the patient began experiencing various side effects, including: Localised Infection, Erythema, Feeling HotAdditional drugs used concurrently: NA. Although Baclofen Intrathecal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Localised Infection, may still occur.
Baclofen Side Effect Report#9924367
Toxicity To Various Agents, Mental Status Changes, Toxic Encephalopathy
This Toxicity To Various Agents problem was reported by a physician from US. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Baclofen (dosage: 10 Mg, Tid). The following drugs were being taken at the same time:
  • Percocet Tablet (1 Df, Qid)
When using Baclofen, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Mental Status Changes, Toxic EncephalopathyThe 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 Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Baclofen Side Effect Report#9924364
Fall, Back Injury, Device Malfunction
This Fall side effect was reported by a consumer or non-health professional from US. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: pain.The patient was prescribed Baclofen (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Dilaudid (hydromorphone)
.After starting to take Baclofen the consumer reported adverse symptoms, such as: Fall, Back Injury, Device MalfunctionThese side effects may potentially be related to Baclofen.
Baclofen Side Effect Report#9915976
Somnolence, Somnolence, Chills, Convulsion
This is a report of a 51-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: muscle spasms, who was treated with Baclofen (dosage: NA, start time:
Jan 20, 2010), combined with: NA. and developed a serious reaction and side effect(s): Somnolence, Somnolence, Chills, Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Baclofen treatment in female patients, resulting in Somnolence side effect. The patient was hospitalized.


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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 Effects Reports
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 Effects Reports
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.

    Discuss Baclofen Side Effects

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    Baclofen Safety Alerts, Active Ingredients, Usage Information

    NDC 0172-4096
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Baclofen
    Name Baclofen
    Dosage Form TABLET
    Route ORAL
    On market since 19880721
    Labeler IVAX Pharmaceuticals, Inc.
    Active Ingredient(s) BACLOFEN
    Strength(s) 10
    Unit(s) mg/1
    Pharma Class GABA 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

    Lioresal Intrathecal (baclofen injection)

    Audience: Neurologists, Neurosurgeons, and other healthcare professionals

    Medtronic and FDA added a BOXED WARNING and strengthened the WARNINGS sections of the prescribing information of Lioresal Intrathecal, indicated for use in the management of severe spasticity of cerebral and spinal origin. The warnings inform healthcare professionals about rare cases of intrathecal baclofen withdrawal that can lead to life threatening sequelae and/or death in patients who abruptly discontinue therapy.

    [April 2002 - Letter - Medtronic]

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