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Subutex Adverse Events Reported to the FDA Over Time

How are Subutex adverse event reports trending over time?

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

Most Common Subutex Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
778 (5.08%)
Drug Withdrawal Syndrome Neonatal
262 (1.71%)
Substance Abuse
251 (1.64%)
Intentional Drug Misuse
239 (1.56%)
Drug Withdrawal Syndrome
230 (1.5%)
Vomiting
216 (1.41%)
Anxiety
209 (1.36%)
Nausea
193 (1.26%)
Suicidal Ideation
185 (1.21%)
Abortion Spontaneous
182 (1.19%)
Incorrect Route Of Drug Administrat...
160 (1.04%)
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Convulsion
154 (1%)
Death
149 (.97%)
Premature Baby
131 (.85%)
Somnolence
124 (.81%)
Depression
122 (.8%)
Headache
112 (.73%)
Hallucination
105 (.68%)
Overdose
105 (.68%)
Hyperhidrosis
101 (.66%)
Pain
101 (.66%)
Withdrawal Syndrome
101 (.66%)
Dyspnoea
96 (.63%)
Drug Dependence
95 (.62%)
Constipation
94 (.61%)
Oedema Peripheral
94 (.61%)
Insomnia
92 (.6%)
Loss Of Consciousness
91 (.59%)
Drug Interaction
89 (.58%)
Dizziness
87 (.57%)
Fatigue
86 (.56%)
Pyrexia
85 (.55%)
Weight Decreased
82 (.53%)
Asthenia
76 (.5%)
Premature Labour
75 (.49%)
Hospitalisation
74 (.48%)
Drug Abuse
72 (.47%)
Abortion Induced
70 (.46%)
Confusional State
70 (.46%)
Diarrhoea
68 (.44%)
Drug Ineffective
66 (.43%)
Endocarditis
64 (.42%)
Tremor
63 (.41%)
Pregnancy
62 (.4%)
Back Pain
61 (.4%)
Completed Suicide
61 (.4%)
Malaise
61 (.4%)
Wrong Technique In Drug Usage Proce...
61 (.4%)
Agitation
58 (.38%)
Coma
55 (.36%)
Respiratory Depression
54 (.35%)
Maternal Drugs Affecting Foetus
53 (.35%)
Intra-uterine Death
52 (.34%)
Decreased Appetite
51 (.33%)
Pneumonia
51 (.33%)
Suicide Attempt
48 (.31%)
Respiratory Arrest
47 (.31%)
Cardiac Arrest
46 (.3%)
Fall
46 (.3%)
Drug Toxicity
43 (.28%)
Feeling Abnormal
43 (.28%)
Abdominal Pain
42 (.27%)
Irritability
42 (.27%)
Respiratory Disorder
42 (.27%)
Sepsis
42 (.27%)
Muscle Spasms
41 (.27%)
Tension
41 (.27%)
Chills
38 (.25%)
Myocardial Infarction
38 (.25%)
Off Label Use
38 (.25%)
Abscess
37 (.24%)
Disorientation
37 (.24%)
Syncope
37 (.24%)
Tachycardia
37 (.24%)
Pulmonary Oedema
36 (.23%)
Abdominal Pain Upper
35 (.23%)
Delirium
35 (.23%)
Hypertension
35 (.23%)
Condition Aggravated
34 (.22%)
Abnormal Behaviour
33 (.22%)
Drug Abuser
33 (.22%)
Hypersensitivity
33 (.22%)
Hypotension
33 (.22%)
Restlessness
33 (.22%)
Oedema
32 (.21%)
Chest Pain
31 (.2%)
Drug Exposure Via Breast Milk
31 (.2%)
Epilepsy
31 (.2%)
Inflammation
31 (.2%)
Injection Site Abscess
31 (.2%)
Miosis
31 (.2%)
Septic Shock
31 (.2%)
Cardiac Failure
30 (.2%)
Drug Diversion
30 (.2%)
Hepatic Failure
30 (.2%)
Pruritus
30 (.2%)
Pulmonary Embolism
29 (.19%)
Sleep Disorder
29 (.19%)
Cardio-respiratory Arrest
28 (.18%)
Hepatitis C
28 (.18%)
Hypoglycaemia
28 (.18%)

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

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

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

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

Drug Dependence
1069
Drug Use For Unknown Indication
867
Product Used For Unknown Indication
558
Pain
297
Back Pain
77
Drug Therapy
56
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Drug Withdrawal Maintenance Therapy
45
Analgesic Therapy
40
Drug Abuse
34
Drug Withdrawal Syndrome
30
Drug Abuser
28
Pain Management
25
Electrolyte Substitution Therapy
23
Detoxification
19
Cancer Pain
18
Drug Detoxification
17
Drug Exposure During Pregnancy
17
Pain In Extremity
16
Osteoarthritis
16
Symphysiolysis
15
Arthralgia
14
Dependence
14
Polysubstance Dependence
13
Substance Abuse
10
Depression
10
Decubitus Ulcer
9
Abdominal Pain
9
Spinal Fracture
9
Analgesia
9
Withdrawal Syndrome
9
Epidural Anaesthesia
8
Ill-defined Disorder
8
Sedative Therapy
8
Multiple Drug Overdose
7
Accidental Exposure
7
Arthritis
6
Spinal Compression Fracture
6
Mental Disorder
5
Humerus Fracture
5
Neuralgia
5
Suicide Attempt
5
Accidental Drug Intake By Child
5
Postoperative Care
5
Spinal Osteoarthritis
4
Chest Pain
4
Drug Level
4
Bone Pain
4
Tumour Pain
4
Drug Therapy Changed
4
Spinal Column Stenosis
4
Anaesthesia
4

Subutex Case Reports

What Subutex 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 Subutex. 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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