Ozobax Side Effects

Generic name: baclofen

Medically reviewed by Drugs.com. Last updated on Jan 5, 2025.

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: oral packet, oral solution, oral suspension, oral tablet.

Other dosage forms:

• intrathecal solution

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not suddenly stop using this medicine without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely. Unwanted side effects (eg, hallucinations, seizures, high fever, rhabdomyolysis) may occur if baclofen (the active ingredient contained in Ozobax) is stopped suddenly.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, other muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using baclofen.

This medicine may cause dizziness, drowsiness, vision problems, or clumsiness or unsteadiness in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see well.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has shakiness or tremors, seizures, or increased muscle tone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common 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:

Serious side effects of Ozobax

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 immediately if any of the following side effects occur while taking baclofen:

Get emergency help immediately if any of the following symptoms of overdose occur while taking baclofen:

Symptoms of overdose

• blurred vision
• dizziness
• drowsiness
• irregular, fast or slow, or shallow breathing
• lightheadedness
• loss of strength or energy
• muscle pain or weakness
• pale or blue lips, fingernails, or skin
• seizures
• sleepiness or unusual drowsiness
• trouble breathing
• unusual weak feeling

For healthcare professionals

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

Cardiovascular adverse events

• 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]

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer