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Baclofen is a muscle relaxer and an antispasmodic agent.
Baclofen is used to treat muscle symptoms; such as spasm, pain and stiffness; caused by multiple sclerosis, spinal cord injuries, or other spinal cord disorders. It is given intrathecally (directly into the spinal cord) or orally (by mouth).
Do not use baclofen at a time when you need muscle tone for safe balance and movement during certain activities. Do not drive or operate heavy machinery until you know how baclofen affects you.
Do not stop using baclofen suddenly, or you could have unpleasant withdrawal symptoms.
You should not use baclofen if you are allergic to it.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
kidney disease;
ulcers;
epilepsy or other seizure disorder;
Parkinson’s disease, cerebral palsy, or rheumatoid disorders;
mental disorders such as schizophrenia or bipolar disorder;
diabetes;
hypertension;
a stroke or blood clot; or
if you also use a narcotic (opioid) medication.
Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your specific risk.
Baclofen has not been studied in pregnant women. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.
It is not known whether baclofen passes into breast milk or if it could harm a nursing baby. Tell your doctor you are breastfeeding before using baclofen.
Baclofen is not approved for use by anyone younger than 12 years old.
Take baclofen exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (do no use a kitchen spoon).
Call your doctor if your muscle symptoms do not improve, or if they get worse.
Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms such as hallucinations or a seizure. Ask your doctor how to safely stop using this medicine.
Store at room temperature away from moisture and heat.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include muscle weakness, vomiting, drowsiness, dilated or pinpoint pupils, weak or shallow breathing, seizure, or coma.
Do not use baclofen at a time when you need muscle tone for safe balance and movement during certain activities. In some situations, it may be dangerous for you to have reduced muscle tone.
Drinking alcohol with this medicine can cause side effects.
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Get emergency medical help if you have signs of an allergic reaction to baclofen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
weak or shallow breathing;
confusion, hallucinations; or
a seizure (convulsions).
Common baclofen side effects may include:
drowsiness, dizziness, weakness, tired feeling;
headache;
sleep problems (insomnia);
nausea, constipation; or
urinating more often than usual.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Taking baclofen with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death.
Tell your physician if you are taking any of the following medications:
ul>Other drugs may interact with baclofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use baclofen only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Baclofen (www.drugs.com/baclofen.html).
Commonly reported side effects of baclofen include: drowsiness. Other side effects include: asthenia, dizziness, headache, and nausea. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to baclofen: oral powder for suspension, oral tablet
Other dosage forms:
Along with its needed effects, baclofen may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur while taking baclofen:
Less common or rare
Symptoms of overdose
Some side effects of baclofen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common or rare
After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
For Healthcare Professionals
Applies to baclofen: compounding powder, intrathecal solution, oral suspension, oral tablet
CardiovascularCommon (1% to 10%): Cardiac output decreased, hypotension, hypertension, diminished cardiovascular functions, peripheral edema
Rare (less than 0.1%): Arrhythmias, palpitations, chest pain
Frequency not reported: Bradycardia, orthostatic hypotension
DermatologicCommon (1% to 10%): Rash, hyperhidrosis, urticaria/pruritus, facial edema
Uncommon (0.1% to 1%): Alopecia, diaphoresis
Frequency not reported: Rash, sweating, contact dermatitis, skin ulcer
EndocrineCommon (1% to 10%): Ovarian cysts are palpable in 4% of women treated with for up to one year
GastrointestinalVery common (10% or more): Nausea (especially at start of therapy) (up to 11%)
Common (1% to 10%): Dry mouth, GI disorder/disturbance, constipation, diarrhea, retching, vomiting, increased salivation
Uncommon (0.1% to 1%): Dysphagia, dehydration, ileus, decreased taste sensation
Rare (less than 0.1%): Colicky abdominal pain, anorexia
Frequency not reported: GI hemorrhage
GenitourinaryVery common (10% or more): Urinary retention (up to 12%)
Common (1% to 10%): Urinary incontinence, urination impaired, sexual dysfunction, urinary frequency, enuresis, dysuria
Rare (less than 0.1%): Erectile dysfunction
Frequency not reported: Dysuria, abnormal ejaculation, oliguria, vaginitis
HematologicFrequency not reported: Leukocytosis, petechial rash
HepaticRare (less than 0.1%): Disorders of hepatic function (e.g., increased AST)
ImmunologicCommon (1% to 10%): Pneumonia
Uncommon (0.1% to 1%): Septicemia
MetabolicCommon (1% to 10%): Decreased appetite
Frequency not reported: Blood glucose increased
MusculoskeletalVery common (10% or more): Hypotonia (up to 52%), lower extremity weakness (up to 15%), disturbances of gait and balance
Common (1% to 10%): Muscular weakness, myalgia, upper extremity weakness, back pain, muscular hypertonia
Nervous systemVery common (10% or more): Somnolence (up to 28%), drowsiness (up to 18%), headache (up to 16%), seizures (especially on discontinuation of therapy) (up to 15%), sedation, dizziness (up to 12%)
Common (1% to 10%): Fatigue, ataxia, tremor, lightheadedness, lassitude, exhaustion, numbness/itching/tingling, slurred speech, lethargy, hypertonia, paresthesia
Rare (less than 0.1%): Dysarthria, dysgeusia, syncope, dyskinesia, coma, potentially life-threatening withdrawal symptoms (as a result of sudden interruption of drug delivery)
OtherCommon (1% to 10%): Tinnitus, pain, asthenia
Uncommon (0.1% to 1%): Accidental injury, weight loss
Very rare (less than 0.01%): Hypothermia
Frequency not reported: Drug withdrawal syndrome
Uncommon (0.1% to 1%): Subdural hemorrhage, accidental injury, weight loss
OcularCommon (1% to 10%): Nystagmus, visual impairment, accommodation disorder, blurred vision, double vision, amblyopia
PsychiatricCommon (1% to 10%): Confusional state, hallucination, depression, insomnia, euphoric mood, nightmare, personality changes
Uncommon (0.1% to 1%): Memory loss/impairment, suicidal ideation, attempted suicide
Rare (less than 0.1%): Excitement
RenalVery rare (less than 0.01%): Kidney calculus
RespiratoryCommon (1% to 10%): Respiratory depression, hypoventilation, dyspnea, bradypnea, feeling of pressure in the chest
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Baclofen (www.drugs.com/baclofen.html).
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