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Baclofen Adverse Events Reported to the FDA Over Time

How are Baclofen adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Baclofen, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Baclofen is flagged as the suspect drug causing the adverse event.

Most Common Baclofen Adverse Events Reported to the FDA

What are the most common Baclofen adverse events reported to the FDA?

Completed Suicide
226 (1.84%)
Overdose
204 (1.66%)
Coma
197 (1.6%)
Convulsion
155 (1.26%)
Confusional State
147 (1.2%)
Muscle Spasticity
132 (1.07%)
Somnolence
127 (1.03%)
Muscle Spasms
122 (.99%)
Drug Withdrawal Syndrome
121 (.98%)
Hypotension
118 (.96%)
Cardiac Arrest
115 (.94%)
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Suicide Attempt
114 (.93%)
Drug Ineffective
111 (.9%)
Loss Of Consciousness
106 (.86%)
Pyrexia
106 (.86%)
Vomiting
106 (.86%)
Death
102 (.83%)
Condition Aggravated
99 (.81%)
Pain
97 (.79%)
Nausea
94 (.77%)
Bradycardia
93 (.76%)
Hypertension
92 (.75%)
Intentional Overdose
92 (.75%)
Delirium
90 (.73%)
Headache
90 (.73%)
Dizziness
88 (.72%)
Hallucination
83 (.68%)
Pneumonia
83 (.68%)
Urinary Tract Infection
83 (.68%)
Fatigue
82 (.67%)
Asthenia
81 (.66%)
Disorientation
81 (.66%)
Respiratory Arrest
79 (.64%)
Implant Site Effusion
74 (.6%)
Mental Status Changes
72 (.59%)
Poisoning
72 (.59%)
Agitation
70 (.57%)
Drug Toxicity
70 (.57%)
Fall
68 (.55%)
Hyperhidrosis
66 (.54%)
Neurotoxicity
65 (.53%)
Tachycardia
63 (.51%)
Depressed Level Of Consciousness
62 (.5%)
Drug Interaction
60 (.49%)
Tremor
60 (.49%)
Withdrawal Syndrome
56 (.46%)
Blood Creatine Phosphokinase Increa...
55 (.45%)
Hypotonia
55 (.45%)
Respiratory Failure
55 (.45%)
Unresponsive To Stimuli
55 (.45%)
Medical Device Complication
52 (.42%)
Diarrhoea
47 (.38%)
Anxiety
46 (.37%)
Depression
45 (.37%)
Muscular Weakness
44 (.36%)
Dysarthria
43 (.35%)
Multiple Drug Overdose
43 (.35%)
Pain In Extremity
42 (.34%)
Respiratory Depression
40 (.33%)
Cardio-respiratory Arrest
39 (.32%)
Hypertonia
39 (.32%)
Back Pain
38 (.31%)
Dyspnoea
38 (.31%)
Sedation
38 (.31%)
Aspartate Aminotransferase Increase...
36 (.29%)
Insomnia
36 (.29%)
Intracranial Hypotension
36 (.29%)
Lethargy
36 (.29%)
Multiple Sclerosis
36 (.29%)
Malaise
35 (.28%)
Paranoia
35 (.28%)
Respiratory Distress
35 (.28%)
Sinus Bradycardia
35 (.28%)
Hyponatraemia
34 (.28%)
Hypothermia
34 (.28%)
Multiple Drug Overdose Intentional
34 (.28%)
Abdominal Pain
33 (.27%)
Constipation
33 (.27%)
Drug Effect Decreased
33 (.27%)
Encephalopathy
33 (.27%)
Gait Disturbance
33 (.27%)
Grand Mal Convulsion
33 (.27%)
Ataxia
32 (.26%)
Device Breakage
32 (.26%)
Alanine Aminotransferase Increased
31 (.25%)
Altered State Of Consciousness
31 (.25%)
Disturbance In Attention
31 (.25%)
Dysphagia
31 (.25%)
Renal Failure Acute
31 (.25%)
Heart Rate Increased
30 (.24%)
Drug Exposure During Pregnancy
29 (.24%)
Fibromyalgia
29 (.24%)
Haemoglobin Decreased
29 (.24%)
Hypoaesthesia
29 (.24%)
Paraesthesia
29 (.24%)
Pneumonia Aspiration
29 (.24%)
Syncope
29 (.24%)
Balance Disorder
28 (.23%)
Blood Pressure Decreased
28 (.23%)
Blood Pressure Increased
28 (.23%)
Infection
28 (.23%)

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This graph shows the top adverse events submitted to the FDA for Baclofen, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Baclofen is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Baclofen

What are the most common Baclofen adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Baclofen, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Baclofen is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Baclofen According to Those Reporting Adverse Events

Why are people taking Baclofen, according to those reporting adverse events to the FDA?

Muscle Spasticity
1374
Muscle Spasms
1021
Product Used For Unknown Indication
566
Drug Use For Unknown Indication
498
Multiple Sclerosis
334
Pain
250
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Muscle Relaxant Therapy
177
Cerebral Palsy
82
Back Pain
80
Hiccups
53
Musculoskeletal Stiffness
49
Spinal Cord Injury
44
Pain In Extremity
39
Restless Legs Syndrome
37
Suicide Attempt
34
Overdose
34
Alcoholism
31
Myalgia
29
Trigeminal Neuralgia
27
Fibromyalgia
24
Tremor
24
Post Laminectomy Syndrome
22
Neuralgia
22
Dystonia
17
Muscle Tightness
15
Hypotonia
15
Cerebrovascular Accident
15
Muscular Weakness
14
Spinal Cord Disorder
13
Ill-defined Disorder
12
Complex Regional Pain Syndrome
12
Brain Injury
12
Migraine
11
Neuropathy Peripheral
11
Headache
11
Cancer Pain
11
Muscle Disorder
11
Back Disorder
10
Paresis
10
Craniocerebral Injury
10
Multiple Drug Overdose
10
Arthritis
10
Autonomic Nervous System Imbalance
10
Bladder Disorder
9
Dyskinesia
9
Muscle Rigidity
9
Arthralgia
8
Quadriplegia
8
Abdominal Pain
8
Rheumatoid Arthritis
8
Myelitis Transverse
7

Drug Labels

LabelLabelerEffective
BaclofenBryant Ranch Rrepack01-JUL-07
BaclofenMcKesson Packaging Services Business Unit of McKesson Corporation01-DEC-09
BaclofenRebel Distributors Corp.01-DEC-09
BaclofenUDL Laboratories, Inc.22-JUN-10
BaclofenSTAT RX USA LLC29-JUN-10
BaclofenUnit Dose Services15-JUL-10
BaclofenUnit Dose Services15-JUL-10
BaclofenPD-Rx Pharmaceuticals, Inc.15-JUL-10
BaclofenMed Health Pharma, LLC01-JAN-11
BaclofenLannett Company, Inc.18-JAN-11
BaclofenMcKesson Packaging Services Business Unit of McKesson Corporation28-MAR-11
BaclofenREMEDYREPACK INC. 04-APR-11
BaclofenAmerican Health Packaging21-APR-11
Baclofen Preferred Pharmaceuticals, Inc06-JUN-11
BaclofenPD-Rx Pharmaceuticals, Inc.01-AUG-11
BaclofenCardinal Health30-SEP-11
BaclofenREMEDYREPACK INC. 10-OCT-11
Baclofen Lake Erie Medical DBA Quality Care Products LLC10-NOV-11
BaclofenLake Erie Medical DBA Quality Care Products LLC10-NOV-11
BaclofenH.J. Harkins Company, Inc.13-DEC-11
BaclofenMcKesson Contract Packaging20-DEC-11
BaclofenRebel Distributors Corp27-DEC-11
BaclofenMylan Pharmaceuticals Inc.01-FEB-12
BaclofenNCS HealthCare of KY, Inc dba Vangard Labs21-FEB-12
BaclofenREMEDYREPACK INC. 13-MAR-12
BaclofenREMEDYREPACK INC. 15-MAR-12
BaclofenPreferred Pharmaceuticals, Inc28-MAR-12
BaclofenUpsher-Smith Laboratories, Inc.19-JUN-12
BaclofenMajor Pharmaceuticals02-AUG-12
BaclofenCardinal Health07-AUG-12
BaclofenLake Erie Medical & Surgical Supply DBA Quality Care Products LLC08-AUG-12
BaclofenPhysicians Total Care, Inc.05-SEP-12
BaclofenAmerican Health Packaging06-SEP-12
BaclofenPreferred Pharmaceuticals, Inc17-OCT-12
BaclofenQualitest Pharmaceuticals28-NOV-12
BaclofenNorthstar RxLLC15-JAN-13
BaclofenREMEDYREPACK INC. 11-FEB-13
BaclofenIVAX Pharmaceuticals, Inc.14-FEB-13
GablofenCNS Therapeutics, Inc.26-MAR-13

Baclofen Case Reports

What Baclofen safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Baclofen. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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