Baclofen side effects - from FDA reports


Summary

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 46,049 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 47,818 users)

On Jul, 17, 2017

46,049 people who take Baclofen are studied.


Number of reports submitted per year:

Baclofen side effects.

Most common side effects over time *:

< 1 month:
  • somnolence
  • vomiting
  • mental status changes
  • confusional state
  • sedation
  • unresponsive to stimuli
  • hypertension
  • tremor
  • urticaria
  • withdrawal syndrome
1 - 6 months:
  • weight decreased
  • malaise
  • paranoia
  • autoimmune hepatitis
  • urinary retention
  • vision blurred
  • vomiting
  • colonic pseudo-obstruction
  • melaena
  • suicidal ideation
6 - 12 months:
  • mouth ulceration
  • urinary tract infection
  • mental status changes
  • cognitive disorder
  • maternal exposure during pregnancy
  • mydriasis
  • tremor
  • vomiting
  • abdominal pain
  • abortion spontaneous
1 - 2 years:
  • wound dehiscence
  • abasia
  • acute respiratory distress syndrome
  • creatinine renal clearance decreased
  • maternal exposure during pregnancy
  • mental status changes
  • multiple sclerosis relapse
  • normal newborn
  • sudden death
  • syncope
2 - 5 years:
  • cervix carcinoma stage iii
  • lung cancer metastatic
  • pneumonia aspiration
  • urinary tract infection
  • viral infection
  • colitis
  • confusional state
  • gastrointestinal haemorrhage
  • psychotic disorder
  • respiratory failure
5 - 10 years:
  • staphylococcal infection
  • mental status changes
  • adverse drug reaction
  • acute myocardial infarction
  • renal cancer
  • serotonin syndrome
  • surgery
  • visual impairment
  • weight decreased
  • withdrawal syndrome
10+ years:
  • brain injury
  • vomiting
  • mental status changes
  • therapeutic response unexpected with drug substitution
  • tinnitus
  • acarodermatitis
  • aggression
  • asthenia
  • dizziness
  • drug administration error
not specified:
  • urinary tract infection
  • vomiting
  • weight decreased
  • weight increased
  • somnolence
  • drug ineffective
  • tremor
  • death
  • multiple sclerosis relapse
  • nausea

Most common side effects by gender *:

female:
  • urinary tract infection
  • vomiting
  • weight decreased
  • weight increased
  • multiple sclerosis relapse
  • somnolence
  • drug ineffective
  • tremor
  • nausea
  • white blood cell count decreased
male:
  • urinary tract infection
  • vomiting
  • weight decreased
  • somnolence
  • tremor
  • drug ineffective
  • death
  • therapeutic response decreased
  • pyrexia
  • overdose

Most common side effects by age *:

0-1:
  • premature baby
  • tremor
  • unresponsive to stimuli
  • bradycardia neonatal
  • foetal exposure during pregnancy
  • low birth weight baby
  • maternal drugs affecting foetus
  • respiratory failure
  • vomiting
  • cardio-respiratory arrest
2-9:
  • vomiting
  • death
  • blood ketone body increased
  • seizure
  • pneumonia aspiration
  • pyrexia
  • reaction to drug excipients
  • renal failure
  • weight decreased
  • implant site infection
10-19:
  • vomiting
  • overdose
  • pyrexia
  • tachycardia
  • seizure
  • suicide attempt
  • completed suicide
  • tremor
  • withdrawal syndrome
  • wound dehiscence
20-29:
  • vomiting
  • urinary tract infection
  • pyrexia
  • seizure
  • multiple sclerosis relapse
  • suicide attempt
  • tremor
  • weight decreased
  • death
  • overdose
30-39:
  • weight decreased
  • vomiting
  • urinary tract infection
  • multiple sclerosis relapse
  • weight increased
  • somnolence
  • tremor
  • pyrexia
  • white blood cell count decreased
  • nausea
40-49:
  • vomiting
  • urinary tract infection
  • weight decreased
  • weight increased
  • multiple sclerosis relapse
  • tremor
  • nausea
  • pyrexia
  • somnolence
  • completed suicide
50-59:
  • urinary tract infection
  • vomiting
  • weight decreased
  • multiple sclerosis relapse
  • weight increased
  • tremor
  • somnolence
  • nausea
  • drug ineffective
  • pyrexia
60+:
  • urinary tract infection
  • vomiting
  • somnolence
  • death
  • weight decreased
  • pneumonia
  • weight increased
  • tremor
  • drug ineffective
  • pain in extremity

* Approximation only. Some reports may have incomplete information.

How to use the study: print a copy of the study and bring it to your health teams to ensure drug risks and benefits are fully discussed and understood.

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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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