FLEQSUVY SIDE EFFECTS

  • Generic Name: baclofen oral suspension
  • Brand Name: Fleqsuvy
  • Drug Class: Skeletal Muscle Relaxants
Last updated on MDtodate: 10/03/2022

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Adverse Reactions from Abrupt Withdrawal of FLEQSUVY
  • Neonatal Withdrawal Symptoms
  • Drowsiness and Sedation
  • Poor Tolerability in Stroke Patients
  • Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Exacerbation of Autonomic Dysreflexia
  • Exacerbation of Epilepsy
  • Posture and Balance Effects
  • Ovarian Cysts

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reaction is transient drowsiness. In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions (up to 15%) are dizziness and weakness. Adverse reactions with a frequency of ≥1% are listed in Table 1.

Table 1. Common (≥1%) Adverse Reactions in Patients Treated with Baclofen for Spasticity

ADVERSE REACTION PERCENT
Drowsiness 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%

 

The following adverse reactions not included in Table 1, classified by body system, were also reported:

Neuropsychiatric: euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure

Cardiovascular: dyspnea, palpitation, chest pain, syncope Gastrointestinal: dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool

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

Other: rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion The following laboratory tests have been found to be abnormal in patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

 

SRC: NLM .