"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
- Clinician Information:
Lioresal Intrathecal Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Lioresal-Intrathecal (baclofen) Injection is a muscle relaxant and antispastic used to treat stiff or rigid muscles (spasticity). This medication is available in generic form. Common side effects include sleepiness, dizziness, nausea, low blood pressure, headache, convulsions, and decreased muscle tone.
Adult and pediatric patients are first given a screening dose of 50 mcg. If a positive effect is observed, the dose will be gradually increased. Lioresal-Intrathecal may interact with morphine. Tell your doctor all medications and supplements you use. During pregnancy, Lioresal-Intrathecal should be taken only if prescribed. Lioresal-Intrathecal passes into breast milk. Effects on a nursing infant are unknown. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.
Our Lioresal-Intrathecal (baclofen) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lioresal Intrathecal FDA Prescribing Information: Side Effects
The most commonly reported adverse events with LIORESAL Intrathecal (baclofen injection) in clinical trials were drowsiness, weakness in the lower extremities, dizziness and seizures.
Adverse drug reactions from clinical trials are listed in the table below according to system organ classes in MedDRA. Within each system organ class, the adverse drug reactions are ranked under headings of frequency, the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each adverse drug reaction: very common ( ≥ 1/10); common ( ≥ 1/100, < 1/10); uncommon ( ≥ 1/1,000, < 1/100); rare ( ≥ 1/10,000, < 1/1,000); very rare ( < 1/10,000), including isolated reports.
Adverse events associated with the delivery system (e.g. mass at the tip of the catheter, catheter dislocation with possible complications, pocket infection, meningitis, overdose due to wrong manipulation of the device) have been reported, whereby in some cases a causal relationship with baclofen cannot be excluded (see WARNINGS). These are in addition to those listed below. In a fatal case of a child (causality with baclofen uncertain), inflammatory signs in the posterior horns and signs of arachnoiditis in proximity of the catheter tip were observed. This corresponds to observations in dogs, where chronic inflammatory reactions to the foreign body of the catheter were observed, independently of baclofen concentration.
Incidence of Most Frequent Adverse Events in US
|Adverse Event||Number of patients reporting events (%)|
|Somnolence||13 (5.3%)||11(5.1%)||18 (8.4%)|
|Weakness, Lower Extremities||1 (0.4%)||11(5.1%)||15 (7.0%)|
|Dizziness||6 (2.4%)||5 (2.3%)||12(5.6%)|
|Convulsion||1 (0.4%)||4 (1.9%)||11 (5.1%)|
|Headache||0 (0%)||3 (1.4%)||9 (4.2%)|
|Nausea/Vomiting||3 (1.2%)||5 (2.3%)||3 (1.4%)|
|Numbness/Itching/Tingling||2 (0.8%)||1 (0.5%)||8 (3.7%)|
|Hypotension||3 (1.2%)||0 (0%)||5 (2.3%)|
|Vision Blurred||0 (0%)||2 (0.9%)||5 (2.3%)|
|Constipation||0 (0%)||2 (0.9%)||5 (2.3%)|
|Hypotonia||2 (0.8%)||3 (1.4%)||2 (0.9%)|
|Dysarthria||0 (0%)||1 (0.5%)||6 (2.8%)|
|Coma (Overdose)||0 (0%)||4 (1.9%)||3 (1.4%)|
|Lethargy||1 (0.4%)||0 (0%)||4 (1.9%)|
|Weakness, Upper Extremities||1 (0.4%)||0 (0%)||4 (1.9%)|
|Hypertension||1 (0.4%)||2 (0.9%)||2 (0.9%)|
|Dyspnea||1 (0.4%)||2 (0.9%)||1 (0.5%)|
In addition to the more common adverse events reported above, the following adverse events were observed during clinical trials elsewhere or reported by clinicians.
Metabolism and nutritional disorders
Common: Depression, anxiety, agitation
Uncommon: Suicide ideation and suicide attempt, hallucinations, paranoia, euphoric mood
Nervous system disorders
Rare: pulmonary embolism.
Uncommon: Deep vein thrombosis, flushing, pallor
Common: Dry mouth, diarrhea, decreased appetite, increased salivation
Respiratory, thoracic and mediastinal disorders
Common: Respiratory depression, pneumonia,
Renal and urinary disorders
Common: urinary incontinence, urinary retention.
Reproduction system and breast disorders
Common: Sexual dysfunction
Skin and subcutaneous tissue disorders
Musculoskeletal and connective tissue disorders
General disorders and administration site conditions
Common: Asthenia, pyrexia, chills, pain
Adverse Drug Reactions From Spontaneous Reports And Literature Cases (frequency not known)
The following adverse drug reactions have been derived from post-marketing experience with LIORESAL Intrathecal via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. Adverse reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness.
Nervous system disorders: dysphoria
Respiratory, thoracic and mediastinal disorders: bradypnea
Read the entire FDA prescribing information for Lioresal Intrathecal (Baclofen Injection) »
Additional Lioresal Intrathecal Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Chronic Pain/Back Pain
Find tips and advances in treatment.