Baclofen

Common brands: Baclofen (Intrathecal), Lioresal (Baclofen), Ozobax Ds, Fleqsuvy, Lyvispah

Top reporter: Maia Pharmaceuticals, Inc.

gamma-Aminobutyric Acid-ergic Agonist [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Benzodiazepine [EPC]Provitamin D2 Compound [EPC]Corticosteroid [EPC]
84,539
Total Reports
26,678
Serious Reports
6,362
Death Reports
30
Reported Reactions
Death Report Ratio: High (7.53%)

Patient Demographics

Male
26,412
Female
52,222

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Baclofen.

# Reaction Reports % of Total
1 FATIGUE 6,212
6.2%
2 PAIN 5,689
5.7%
3 DRUG INEFFECTIVE 5,531
5.6%
4 FALL 5,456
5.5%
5 NAUSEA 4,648
4.7%
6 HEADACHE 4,393
4.4%
7 GAIT DISTURBANCE 4,130
4.1%
8 OFF LABEL USE 3,730
3.7%
9 DIZZINESS 3,582
3.6%
10 URINARY TRACT INFECTION 3,512
3.5%
11 ASTHENIA 3,432
3.4%
12 MULTIPLE SCLEROSIS RELAPSE 3,406
3.4%
13 MUSCLE SPASMS 3,337
3.4%
14 DIARRHOEA 3,086
3.1%
15 VOMITING 2,860
2.9%
16 SOMNOLENCE 2,737
2.7%
17 INSOMNIA 2,678
2.7%
18 DYSPNOEA 2,661
2.7%
19 PAIN IN EXTREMITY 2,648
2.7%
20 BACK PAIN 2,462
2.5%
21 DEPRESSION 2,456
2.5%
22 MALAISE 2,432
2.4%
23 CONDITION AGGRAVATED 2,367
2.4%
24 HYPOAESTHESIA 2,359
2.4%
25 MUSCULAR WEAKNESS 2,340
2.4%
26 MUSCLE SPASTICITY 2,324
2.3%
27 MULTIPLE SCLEROSIS 2,323
2.3%
28 ARTHRALGIA 2,300
2.3%
29 PNEUMONIA 2,280
2.3%
30 PYREXIA 2,169
2.2%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.