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 48,798 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 50,606 users)

On Jan, 18, 2018

48,798 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
  • pain
  • tremor
  • hypertension
  • urticaria
1 - 6 months:
  • weight decreased
  • malaise
  • paranoia
  • autoimmune hepatitis
  • urinary retention
  • vision blurred
  • vomiting
  • weight increased
  • colonic pseudo-obstruction
  • melaena
6 - 12 months:
  • mouth ulceration
  • urinary tract infection
  • mental status changes
  • pain
  • cognitive disorder
  • maternal exposure during pregnancy
  • mydriasis
  • pregnancy
  • tremor
  • vomiting
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
  • pain
  • sudden death
2 - 5 years:
  • cervix carcinoma stage iii
  • viral infection
  • lung cancer metastatic
  • pneumonia aspiration
  • therapeutic response unexpected
  • urinary tract infection
  • colitis
  • confusional state
  • fall
  • gastrointestinal haemorrhage
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:
  • vomiting
  • brain injury
  • mental status changes
  • therapeutic response unexpected with drug substitution
  • tinnitus
  • acarodermatitis
  • aggression
  • anxiety
  • asthenia
  • dizziness
not specified:
  • urinary tract infection
  • vomiting
  • pain
  • weight decreased
  • weight increased
  • drug ineffective
  • somnolence
  • multiple sclerosis relapse
  • tremor
  • death

Most common side effects by gender *:

female:
  • urinary tract infection
  • vomiting
  • weight decreased
  • pain
  • weight increased
  • multiple sclerosis relapse
  • somnolence
  • drug ineffective
  • tremor
  • nausea
male:
  • urinary tract infection
  • vomiting
  • pain
  • weight decreased
  • drug ineffective
  • somnolence
  • tremor
  • death
  • muscle spasticity
  • therapeutic response decreased

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
  • seizure
  • blood ketone body increased
  • implant site infection
  • withdrawal syndrome
  • pneumonia
  • pneumonia aspiration
  • pyrexia
  • reaction to drug excipients
10-19:
  • vomiting
  • muscle spasticity
  • overdose
  • pyrexia
  • tachycardia
  • seizure
  • suicide attempt
  • withdrawal syndrome
  • completed suicide
  • tremor
20-29:
  • vomiting
  • urinary tract infection
  • muscle spasticity
  • pain
  • pyrexia
  • multiple sclerosis relapse
  • seizure
  • suicide attempt
  • tremor
  • somnolence
30-39:
  • weight decreased
  • vomiting
  • urinary tract infection
  • multiple sclerosis relapse
  • weight increased
  • somnolence
  • tremor
  • pain
  • pyrexia
  • white blood cell count decreased
40-49:
  • vomiting
  • urinary tract infection
  • pain
  • weight decreased
  • weight increased
  • multiple sclerosis relapse
  • completed suicide
  • tremor
  • nausea
  • drug ineffective
50-59:
  • urinary tract infection
  • vomiting
  • weight decreased
  • pain
  • multiple sclerosis relapse
  • weight increased
  • tremor
  • somnolence
  • nausea
  • drug ineffective
60+:
  • urinary tract infection
  • vomiting
  • somnolence
  • pain
  • death
  • weight decreased
  • pneumonia
  • weight increased
  • tremor
  • drug ineffective

* Approximation only. Some reports may have incomplete information.

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

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Baclofen side effects from FDA and eHealthMe reports

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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:

Questions to the study

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User posts to the study

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