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:

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

Want to find out more about the FDA reports used in the study? You can request them from FDA.

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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.

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