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METHADOSE

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Methadose Adverse Events Reported to the FDA Over Time

How are Methadose adverse event reports trending over time?

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

Most Common Methadose Adverse Events Reported to the FDA

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

Cardiac Arrest
1060 (4.03%)
Respiratory Arrest
1020 (3.87%)
Completed Suicide
1019 (3.87%)
Cardio-respiratory Arrest
595 (2.26%)
Drug Withdrawal Syndrome Neonatal
589 (2.24%)
Overdose
585 (2.22%)
Drug Toxicity
580 (2.2%)
Death
472 (1.79%)
Drug Interaction
398 (1.51%)
Drug Abuse
385 (1.46%)
Multiple Drug Overdose
339 (1.29%)
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Electrocardiogram Qt Prolonged
296 (1.12%)
Drug Exposure During Pregnancy
291 (1.11%)
Somnolence
280 (1.06%)
Respiratory Depression
239 (.91%)
Drug Ineffective
229 (.87%)
Intentional Drug Misuse
228 (.87%)
Poisoning
225 (.85%)
Torsade De Pointes
209 (.79%)
Accidental Overdose
203 (.77%)
Vomiting
197 (.75%)
Loss Of Consciousness
180 (.68%)
Premature Baby
172 (.65%)
Drug Abuser
171 (.65%)
Drug Withdrawal Syndrome
165 (.63%)
Nausea
159 (.6%)
Pulmonary Oedema
151 (.57%)
Convulsion
147 (.56%)
Multiple Drug Overdose Intentional
145 (.55%)
Nystagmus
139 (.53%)
Pain
137 (.52%)
Coma
133 (.51%)
Confusional State
124 (.47%)
Premature Labour
116 (.44%)
Hypotension
115 (.44%)
Dyspnoea
109 (.41%)
Headache
109 (.41%)
Intentional Overdose
109 (.41%)
Pneumonia
109 (.41%)
Strabismus
108 (.41%)
Fall
106 (.4%)
Unresponsive To Stimuli
106 (.4%)
Dizziness
105 (.4%)
Hyperhidrosis
105 (.4%)
Fatigue
104 (.4%)
Malaise
104 (.4%)
Developmental Delay
101 (.38%)
Pulmonary Congestion
98 (.37%)
Depressed Level Of Consciousness
97 (.37%)
Serotonin Syndrome
95 (.36%)
Agitation
94 (.36%)
Syncope
94 (.36%)
Visual Acuity Reduced
94 (.36%)
Congenital Nystagmus
92 (.35%)
Drug Screen Positive
91 (.35%)
Sedation
89 (.34%)
Drug Dependence
87 (.33%)
Constipation
85 (.32%)
Mental Status Changes
84 (.32%)
Respiratory Failure
82 (.31%)
Withdrawal Syndrome
82 (.31%)
Insomnia
80 (.3%)
Ventricular Tachycardia
80 (.3%)
Lethargy
77 (.29%)
Multiple Drug Overdose Accidental
77 (.29%)
Therapeutic Agent Toxicity
76 (.29%)
Anxiety
75 (.28%)
Substance Abuse
75 (.28%)
Feeling Abnormal
72 (.27%)
Asthenia
71 (.27%)
Drug Diversion
70 (.27%)
Maternal Drugs Affecting Foetus
70 (.27%)
Medication Error
70 (.27%)
Arrhythmia
69 (.26%)
Aspiration
69 (.26%)
Miosis
68 (.26%)
Oedema Peripheral
68 (.26%)
Tremor
64 (.24%)
Accidental Poisoning
63 (.24%)
Pneumonia Aspiration
61 (.23%)
Depression
60 (.23%)
Pain In Extremity
60 (.23%)
Diarrhoea
58 (.22%)
Pyrexia
58 (.22%)
Rhabdomyolysis
56 (.21%)
Blood Potassium Decreased
55 (.21%)
Heart Rate Increased
55 (.21%)
Accidental Death
54 (.21%)
Bronchopneumonia
54 (.21%)
Abnormal Behaviour
53 (.2%)
Brain Oedema
52 (.2%)
Disorientation
52 (.2%)
Chest Pain
50 (.19%)
Delirium
50 (.19%)
Hypokalaemia
50 (.19%)
Self-medication
50 (.19%)
Weight Decreased
50 (.19%)
Abdominal Pain
49 (.19%)
Hallucination
49 (.19%)
Cardiomegaly
48 (.18%)
Dysarthria
47 (.18%)

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This graph shows the top adverse events submitted to the FDA for Methadose, 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 Methadose 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 Methadose

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

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This graph shows the top categories of adverse events submitted to the FDA for Methadose, 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 Methadose 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 Methadose According to Those Reporting Adverse Events

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

Pain
1380
Drug Use For Unknown Indication
972
Product Used For Unknown Indication
915
Drug Dependence
546
Back Pain
328
Drug Withdrawal Maintenance Therapy
283
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Cancer Pain
100
Drug Abuse
86
Dependence
79
Drug Abuser
75
Ill-defined Disorder
73
Pain Management
66
Drug Exposure During Pregnancy
50
Fibromyalgia
43
Neck Pain
36
Breakthrough Pain
34
Foetal Exposure During Pregnancy
33
Drug Withdrawal Syndrome
32
Arthralgia
31
Abnormal Behaviour
29
Neuralgia
28
Mental Disorder
27
Substance Abuse
25
Bone Pain
24
Abdominal Pain
24
Pain In Extremity
23
Suicide Attempt
21
Neuropathy Peripheral
21
Detoxification
21
Musculoskeletal Pain
18
Analgesic Therapy
18
Drug Detoxification
17
Migraine
14
Back Disorder
14
Back Injury
14
Polysubstance Dependence
13
Drug Rehabilitation
13
Arthritis
12
Intervertebral Disc Protrusion
12
Headache
12
Cough
11
Complex Regional Pain Syndrome
10
Pelvic Pain
10
Abdominal Pain Upper
10
Drug Therapy
10
Rheumatoid Arthritis
10
Analgesic Effect
9
Withdrawal Syndrome
9
Intervertebral Disc Degeneration
9
Completed Suicide
8
Procedural Pain
8

Drug Labels

LabelLabelerEffective
Methadose DispersibleMallinckrodt Inc.24-AUG-09
Methadone HydrochlorideMallinckrodt Inc.24-AUG-09
MethadoseMallinckrodt, Inc.28-JAN-11
Methadose Sugar-freeMallinckrodt, Inc.28-JAN-11
MethadoseMallinckrodt, Inc.01-JUL-12

Methadose Case Reports

What Methadose 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 Methadose. 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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