Fleqsuvy side effects

Generic name: baclofen
Dosage form: oral suspension

Medically reviewed by A Ras MD.  Updated March 28, 2022

What is Fleqsuvy

Fleqsuvy (baclofen oral suspension) is a gamma-aminobutyric acid (GABA-ergic) agonist available as 25 mg per 5 mL (5 mg/mL) suspension for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid and its structural formula is:Fleqsuvy side effects

Molecular formula is C10H12C1NO2.
Molecular Weight is 213.66 g/mol.

Baclofen USP is a white to off-white, odorless, or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform.

The Fleqsuvy (baclofen oral suspension) inactive ingredients are artificial grape flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, hydroxyethyl cellulose, propylene glycol, purified water, simethicone emulsion, sodium benzoate, and sucralose.

Warnings and precautions

Negative Reactions resulting from the abrupt Retraction of Fleqsuvy

The abrupt withdrawal of baclofen regardless of reason can cause negative reactions such as seizures, hallucinations, and hallucinations. They also have hyper-ever and altered mental state, hyper-intense rebound spasticity, and rigidity of the muscles, which in some cases, has led to rhabdomyolysis and multiple organ system failures, and even death. Therefore, lower the dosage gradually after Fleqsuvy is stopped unless the medical situation requires a fast withdrawal.

Neonatal withdrawal symptoms

In neonates, withdrawal symptoms who had mothers treated with baclofen in the course of pregnancy have been observed from hours to days after the delivery. The signs of withdrawal among these infants have included an increase in muscles, tremors as well as jitteriness, and seizures. If the benefits of the treatment outweigh the risks to the fetus and Fleqsuvy is used throughout pregnancy, slowly reduce the dose and cease Fleqsuvy prior to birth. If a gradual withdrawal isn’t possible, notify the caregivers or parents of the neonate who is exposed to the potential for withdrawal of the neonate.

Sedation and Drowsiness

Sedation and drowsiness have been observed in as high as 60% of those who take baclofen which is the main ingredient of Fleqsuvy. Patients should stay clear of motor vehicles, or other hazardous machinery as well as activities that are a risk due to reduced alertness after taking Fleqsuvy, or increasing their dose until they are aware of how the drug affects them.

Be aware to be aware that central nervous system depressant effects of Fleqsuvy could be in addition to the effects of alcohol and other CNS depressants.

Insufficient Tolerability for Stroke Patients

Fleqsuvy must be taken with caution by patients who have suffered a stroke. Baclofen is not a significant benefit to stroke sufferers. Patients with stroke have also demonstrated low tolerance to the drug.

Exacerbation of Schizophrenia, Psychotic Disorders, or Confusional State

Fleqsuvy is recommended to be used with caution when treating those suffering from schizophrenia, psychotic disorders, or states of confusion. In the event of treatment with Fleqsuvy, such patients must be monitored closely since exacerbations of these disorders were observed following the administration of baclofen via the oral route.

Exacerbation of Autonomic Dysreflexia

Fleqsuvy is to be used cautiously in patients with an autonomic dysreflexia history. The presence of stimuli that cause nociceptive or sudden removal of Fleqsuvy can trigger an autonomic dysreflexia episode.

The exacerbation Epilepsy

Fleqsuvy must be administered with caution for patients suffering from epilepsy. A decrease in seizure control has been documented in patients who take baclofen.

The effects of posture and balance

Fleqsuvy must be utilized with caution when patients are suffering from spasticity is used to maintain an upright posture and maintain balance during the course of movement, or when spasticity is employed to gain more function.

Ovarian Cysts

An increase in the frequency of ovarian cysts has been observed in female rats who were treated with oral baclofen. Ovarian cysts have been identified through palpation in around 4 percent of the MS patients treated with oral baclofen for up to a year. Most of the time the cysts disappear on their own as patients continued to receive the medication. Ovarian cysts can be present in about 10% up to 5 percent of a typical female.

Fleqsuvy Side effects

Fleqsuvy side effects are unwanted reactions that may accompany with the use of this drug.

For consumer

A drug may have some undesired side effects in addition to its intended effects. Although not all of these side effects are likely to occur, if they do, medical treatment may be required.

If any of the following side effects develop, contact your doctor right away:

Less common or rare

  • Bloody or dark urine
  • chest pain
  • clumsiness, unsteadiness, trembling, or other problems with muscle control
  • fainting
  • false sense of well-being
  • mental depression or other mood changes
  • pounding heartbeat
  • ringing or buzzing in the ears
  • seeing or hearing things that are not there
  • skin rash or itching
  • slurred speech or other speech problems
  • swelling of the ankles
  • unexplained muscle stiffness
  • unusual excitement

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

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

There may be certain adverse effects that may not require medical treatment. As your body responds to the drug, these side effects may fade away during treatment. In addition, your health care provider may be able to advise you on how to avoid or mitigate some of these adverse effects. If any of the following side effects persist or become troublesome, or if you have any questions about them, consult your doctor:

More common

  • Confusion
  • constipation
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • headache
  • increased need to urinate
  • nausea
  • passing urine more often
  • sweating
  • trouble sleeping
  • unusual tiredness or weakness

Less common or rare

  • Diarrhea
  • loss of appetite
  • muscle or joint pain
  • numbness or tingling in the hands or feet
  • stomach pain or discomfort
  • stuffy nose
  • weight gain

For Medical Professionals

This applies to baclofen: compounding powder, intrathecal solution, oral liquid, 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 reportedBradycardia, orthostatic hypotension

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

Endocrine

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

Gastrointestinal

  • Very common (10% or more): Nausea (especially at the 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

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

Hematologic

Hepatic

Rare (less than 0.1%): Disorders of hepatic function (e.g., increased AST)

Immunologic

  • Common (1% to 10%): Pneumonia
  • Uncommon (0.1% to 1%): Septicemia

Metabolic

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

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

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 a sudden interruption of drug delivery)

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

Ocular

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

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

Renal

  • Very rare (less than 0.01%): Kidney calculus

Respiratory

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

 

Experiences in Clinical Trials

Since the clinical trials take place in diverse conditions, the rates of adverse reactions found in the clinical trials for a drug are not directly comparable to rates observed in trials conducted for another drug. They may not accurately reflect the actual rates in actual use.

The most frequent adverse reaction is temporary Drowsiness. In a controlled study of 175 participants, transient sleepiness was reported in 63% of the patients taking baclofen in comparison to 36% who were in the control group. Other adverse reactions that are common (up to 15 percent) include dizziness and weakness. Reactions that cause adverse reactions with more than 1% frequency are described in Table 1.

Table 1. Common (>=1 percent) Adverse Reactions among Patients who are treated by Baclofen for Spasticity
ADVERSE REACTION Percentage
Drool 10-63%
Dizziness 5-15%
Weakness 5-15%
Nausea 4-12%
Confusion 1-11%
Hypotension 0-9%
Headache 4-8%
Insomnia 2-7%
Constipation 2-6%
Urinary Frequency 2-6%
Fatigue 2-4%

Some adverse reactions, not included in Table 1 classified by a system of the body were also reported

Neuropsychiatric symptoms include euphoria, enthusiasm depression, hallucinations muscles pain, paresthesia as well as tinnitus, slurred speaking, coordination disorders stiffness, dystonia ataxia, blurred sight, strabismus, nystagmus diplopia, mydriasis dysarthria, epileptic seizures

Cardiovascular: dyspnea, palpitation, chest pain, syncope

Gastrointestinal: dry mouth anorexia, a taste disorder nausea, abdominal pain as well as diarrhea. a positive test for blood occult in the stool

Genitourinary: enuresis and dysuria, urinary retention, inability to ejaculate, impotence and nocturia, hematuria, and enuresis.

Other symptoms: rash, psoriasis, and ankle edema. Excessive weight gain, perspiration nasal congestion

The following tests in the laboratory have been identified as abnormal for patients taking baclofen increased SGOT as well as elevated alkaline-phosphatase and an increase in blood sugar.

 

How supplied/storage

how supplied

Fleqsuvy (baclofen oral suspension) has 25 mg of 5 milliliters (5 mg/mL) baclofen. This is an extremely concentrated orange-to yellow-colored grape-flavored suspension that is available in high-density polyethylene (HDPE) bottles that are white, polypropylene, and child-resistant closures that have an inner seal made of foam and a heat-induction-layered seal inside.

120 milliliters NDC 52652-6001-1

300 milliliters, NDC 52652-6001-2

Storing and handling

Keep at 20degC- 25degC (68degF to 77degF) The permitted range of excursions is 15deg to 30deg (59deg and 86deg F) (see USP Controlled Room Temperature).

Throw away any portion that is not used 2 months following the first opening.

 

Label

  • NDC 52652-60001-1
  • Rx Only
  • FLEQSUVY™ (baclofen oral suspension)
  • 25 mg per 5 mL (5 mg/mL) Concentrated Formulation

 

Fleqsuvy side effects

 

 

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