Baclofen side effects - from FDA reports


In this review, we analyze Baclofen side effects by the time on the drug, gender and age of the people who have side effects while taking Baclofen. The review is based on 62,094 people who have side effects while taking the drug from FDA, and is updated regularly.

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Baclofen

Baclofen has active ingredients of baclofen. It is often used in muscle spasms. (latest outcomes from Baclofen 63,904 users)


On Jan, 10, 2019

62,094 people who take Baclofen are studied.


Number of reports submitted per year:

Baclofen side effects.

Most common side effects over time *:

< 1 month:
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Vomiting
  • Mental status changes (general changes in brain function, such as confusion, amnesia (memory loss), loss of alertness, loss of orientation)
  • Unresponsive to stimuli
  • Confusional state
  • Sedation
  • Vision blurred
  • Hypertension (high blood pressure)
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Urticaria (rash of round, red welts on the skin that itch intensely)
1 - 6 months:
  • Pneumonia
  • Autoimmune hepatitis
  • Mental status changes (general changes in brain function, such as confusion, amnesia (memory loss), loss of alertness, loss of orientation)
  • Weight increased
  • Colonic pseudo-obstruction (severe impairment in the ability of the intestines to push food through)
  • Hallucination (an experience involving the perception of something not present)
  • Hepatocellular injury (liver injury)
  • Melaena (the passage of black, tarry stools)
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Stress
6 - 12 months:
  • Urinary tract infection
  • Mouth ulceration (mouth ulcers)
  • Maternal exposure during pregnancy (use of substance during pregnancy)
  • Mental status changes (general changes in brain function, such as confusion, amnesia (memory loss), loss of alertness, loss of orientation)
  • Pain
  • Pregnancy
  • Sleep apnoea syndrome (a sleep-related disorder in which the effort to breathe is diminished or absent)
  • Suicidal ideation
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Vomiting
1 - 2 years:
  • Wound dehiscence
  • Abasia (inability to walk)
  • Multiple sclerosis relapse (reoccurrence of a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath)
  • Creatinine renal clearance decreased
  • Maternal exposure during pregnancy (use of substance during pregnancy)
  • Renal failure (kidney dysfunction)
  • Completed suicide (act of taking one's own life)
  • Mental status changes (general changes in brain function, such as confusion, amnesia (memory loss), loss of alertness, loss of orientation)
  • Pain
  • Pruritus (severe itching of the skin)
2 - 5 years:
  • Cervix carcinoma stage iii (cancer has spread to the lower third of the vagina, and/or to the pelvic wall)
  • Lung cancer metastatic (lung cancer spreads to other parts)
  • Pneumonia aspiration (bronchopneumonia that develops due to the entrance of foreign materials into the bronchial tree)
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Suicidal ideation
  • Therapeutic response unexpected
  • Urinary tract infection
  • Colitis (inflammation of colon)
  • Confusional state
  • Fall
5 - 10 years:
  • Staphylococcal infection (an infection with staphylococcus bacteria)
  • Adverse drug reaction
  • Mental status changes (general changes in brain function, such as confusion, amnesia (memory loss), loss of alertness, loss of orientation)
  • Pneumonia
  • Acute myocardial infarction (acute heart attack)
  • Chronic kidney disease
  • Kidney infection
  • Renal cancer (cancer of kidney)
  • Serotonin syndrome (occurs when two drugs that affect the body's level of serotonin are taken together at the same time)
  • Visual impairment
10+ years:
  • Vomiting
  • Brain injury
  • Disability
  • Dizziness
  • Drug administration error
  • Fall
  • Feeling abnormal
  • Hypersomnia (excessive daytime sleepiness (eds))
  • Implant site infection
  • Influenza
not specified:
  • Urinary tract infection
  • Vomiting
  • Pain
  • Weight decreased
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Multiple sclerosis relapse (reoccurrence of a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath)
  • Drug ineffective
  • Weight increased
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Death

Most common side effects by gender *:

female:
  • Urinary tract infection
  • Vomiting
  • Pain
  • Weight decreased
  • Multiple sclerosis relapse (reoccurrence of a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath)
  • Weight increased
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Drug ineffective
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Nausea (feeling of having an urge to vomit)
male:
  • Urinary tract infection
  • Pain
  • Pyrexia (fever)
  • Withdrawal syndrome (a discontinuation syndrome is a set of symptoms occurred due to discontinuation of substance)
  • Multiple sclerosis relapse (reoccurrence of a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath)
  • Pneumonia
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Overdose
  • Vomiting
  • Weight decreased

Most common side effects by age *:

0-1:
  • Premature baby
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Unresponsive to stimuli
  • Vomiting
  • Seizure (abnormal excessive or synchronous neuronal activity in the brain)
  • Bradycardia neonatal (sinus rhythm with a heart rate below the normal limit in newborn)
  • Foetal exposure during pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect)
  • Low birth weight baby
  • Maternal drugs affecting foetus (chemical affecting the baby before birth taken by mother)
  • Respiratory failure (inadequate gas exchange by the respiratory system)
2-9:
  • Death
  • Vomiting
  • Seizure (abnormal excessive or synchronous neuronal activity in the brain)
  • Blood ketone body increased
  • Thrombocytopenia (decrease of platelets in blood)
  • Withdrawal syndrome (a discontinuation syndrome is a set of symptoms occurred due to discontinuation of substance)
  • Implant site infection
  • Pneumonia
  • Pneumonia aspiration (bronchopneumonia that develops due to the entrance of foreign materials into the bronchial tree)
  • Pyrexia (fever)
10-19:
  • Vomiting
  • Muscle spasticity (tight or stiff muscles and an inability to control those muscles)
  • Overdose
  • Drug withdrawal syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation)
  • Pyrexia (fever)
  • Seizure (abnormal excessive or synchronous neuronal activity in the brain)
  • Withdrawal syndrome (a discontinuation syndrome is a set of symptoms occurred due to discontinuation of substance)
  • Death
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Wound dehiscence
20-29:
  • Suicide attempt
  • Weight decreased
  • Vomiting
  • Urinary tract infection
  • Muscle spasticity (tight or stiff muscles and an inability to control those muscles)
  • Status epilepticus (a life-threatening condition in which the brain is in a state of persistent seizure)
  • Pyrexia (fever)
  • Pain
  • Unresponsive to stimuli
  • Multiple sclerosis relapse (reoccurrence of a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath)
30-39:
  • Weight decreased
  • Vomiting
  • Urinary tract infection
  • Multiple sclerosis relapse (reoccurrence of a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath)
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Weight increased
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Pain
  • White blood cell count decreased
  • Nausea (feeling of having an urge to vomit)
40-49:
  • Urinary tract infection
  • Vomiting
  • Pain
  • Weight decreased
  • Weight increased
  • Multiple sclerosis relapse (reoccurrence of a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath)
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Completed suicide (act of taking one's own life)
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Nausea (feeling of having an urge to vomit)
50-59:
  • Urinary tract infection
  • Vomiting
  • Pain
  • Weight decreased
  • Multiple sclerosis relapse (reoccurrence of a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath)
  • Weight increased
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • White blood cell count decreased
  • Nausea (feeling of having an urge to vomit)
60+:
  • Urinary tract infection
  • Vomiting
  • Somnolence (a state of near-sleep, a strong desire for sleep)
  • Pain
  • Death
  • Weight decreased
  • Pneumonia
  • Weight increased
  • Tremor (trembling or shaking movements in one or more parts of your body)
  • Drug ineffective

* Approximation only. Some reports may have incomplete information.

FDA reports used in this study

You are not alone:

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All Baclofen side effects from A to Z

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On eHealthMe, Baclofen (baclofen) is often used to treat muscle spasticity. Find out below the conditions the drugs are used for and how effective they are.

What is the drug used for and how effecitve is it:


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NOTE: The study is based on active ingredients and brand name. Other drugs that have the same active ingredients (e.g. generic drugs) are NOT considered.

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