Ozobax Side Effects

Generic name: baclofen

Medically reviewed by Drugs.com. Last updated on May 30, 2024.

Note: This document provides detailed information about Ozobax Side Effects associated with baclofen. Some dosage forms listed on this page may not apply specifically to the brand name Ozobax.

Applies to baclofen: intrathecal solution.

Other dosage forms:

• oral packet, oral solution, oral suspension, oral tablet

Important warnings This medicine can cause some serious health issues

Intrathecal route (solution)

Do not discontinue abruptly.

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in a condition that includes high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, and in rare cases has led to rhabdomyolysis, multiple organ-system failure, and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms.

Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal.

Special attention should be given to patients at apparent risk (eg, spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).

Consult the technical manual of the implantable infusion system for additional post-implant clinician and patient information.

Serious side effects of Ozobax

Along with its needed effects, baclofen (the active ingredient contained in Ozobax) 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:

More common

• convulsions (seizures)

Less common or rare

• blurred vision or double vision
• fainting
• mental depression
• muscle weakness
• ringing or buzzing in ears
• seeing, hearing, or feeling things that are not there
• shortness of breath or troubled breathing

Symptoms of overdose

• convulsions (seizures)
• dizziness, drowsiness, or lightheadedness
• increased watering of the mouth
• mental confusion
• muscle weakness
• nausea and/or vomiting
• shortness of breath or troubled breathing

Other side effects of Ozobax

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

• constipation
• difficult urination
• dizziness
• headache
• nausea and/or vomiting
• numbness or tingling in hands or feet
• sleepiness

Less common

• clumsiness, unsteadiness, trembling, or other problems with muscle control
• diarrhea
• difficulty sleeping
• dizziness or lightheadedness, especially when getting up from a lying or sitting position
• dry mouth
• frequent urge to urinate
• irritation of the skin at the site where the pump is located
• itching of the skin
• sexual problems
• slurred speech or other speech problems
• swelling of ankles, feet, or lower legs
• trembling or shaking

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:

• convulsions (seizures)
• facial flushing, headache, increased sweating, or slow heartbeat
• increased muscle spasms
• seeing, hearing, or feeling things that are not there

For healthcare professionals

Applies to baclofen: compounding powder, intrathecal solution, oral granule, oral liquid, oral solution, oral suspension, oral tablet.

Cardiovascular

• Common (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^[Ref]

Dermatologic

• Common (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^[Ref]

Endocrine

• Common (1% to 10%): Ovarian cysts are palpable in 4% of women treated with for up to one year^[Ref]

Gastrointestinal

• Very 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^[Ref]

Genitourinary

• Very 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^[Ref]

Hematologic

• Frequency not reported: Leukocytosis, petechial rash^[Ref]

Hepatic

• Rare (less than 0.1%): Disorders of hepatic function (e.g., increased AST)^[Ref]

Immunologic

• Common (1% to 10%): Pneumonia
• Uncommon (0.1% to 1%): Septicemia^[Ref]

Metabolic

• Common (1% to 10%): Decreased appetite
• Frequency not reported: Blood glucose increased^[Ref]

Musculoskeletal

• Very 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^[Ref]

Nervous system

• Very 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)^[Ref]

Other

• Common (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^[Ref]

Ocular

• Common (1% to 10%): Nystagmus, visual impairment, accommodation disorder, blurred vision, double vision, amblyopia^[Ref]

Psychiatric

• Common (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^[Ref]

Renal

• Very rare (less than 0.01%): Kidney calculus^[Ref]

Respiratory

• Common (1% to 10%): Respiratory depression, hypoventilation, dyspnea, bradypnea, feeling of pressure in the chest^[Ref]

Further information

Ozobax side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer