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CODEINE SULFATE

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Codeine Sulfate Adverse Events Reported to the FDA Over Time

How are Codeine Sulfate adverse event reports trending over time?

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

Most Common Codeine Sulfate Adverse Events Reported to the FDA

What are the most common Codeine Sulfate adverse events reported to the FDA?

Completed Suicide
445 (2.27%)
Vomiting
316 (1.61%)
Drug Hypersensitivity
306 (1.56%)
Overdose
300 (1.53%)
Drug Toxicity
258 (1.31%)
Nausea
227 (1.16%)
Drug Interaction
223 (1.14%)
Dyspnoea
194 (.99%)
Somnolence
180 (.92%)
Malaise
177 (.9%)
Multiple Drug Overdose
170 (.87%)
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Cardiac Arrest
161 (.82%)
Death
158 (.81%)
Headache
156 (.79%)
Loss Of Consciousness
153 (.78%)
Respiratory Arrest
148 (.75%)
Abdominal Pain
147 (.75%)
Dizziness
145 (.74%)
Drug Ineffective
143 (.73%)
Multiple Drug Overdose Intentional
136 (.69%)
Pyrexia
136 (.69%)
Constipation
134 (.68%)
Drug Abuse
134 (.68%)
Confusional State
126 (.64%)
Back Pain
121 (.62%)
Hypotension
115 (.59%)
Pain
110 (.56%)
Cardio-respiratory Arrest
108 (.55%)
Drug Exposure During Pregnancy
105 (.54%)
Suicide Attempt
104 (.53%)
Depression
101 (.51%)
Diarrhoea
99 (.5%)
Fatigue
99 (.5%)
Intentional Overdose
99 (.5%)
Intentional Drug Misuse
97 (.49%)
Hallucination
96 (.49%)
Alanine Aminotransferase Increased
94 (.48%)
Asthenia
93 (.47%)
Serotonin Syndrome
92 (.47%)
Fall
86 (.44%)
Cough
84 (.43%)
Pruritus
84 (.43%)
Respiratory Depression
84 (.43%)
Rash
81 (.41%)
Convulsion
80 (.41%)
Feeling Abnormal
77 (.39%)
Medication Error
76 (.39%)
Hyperhidrosis
75 (.38%)
Hypertension
74 (.38%)
Poisoning
74 (.38%)
Accidental Overdose
73 (.37%)
Hypersensitivity
73 (.37%)
Metabolic Acidosis
72 (.37%)
Dehydration
71 (.36%)
Weight Increased
71 (.36%)
Depressed Level Of Consciousness
68 (.35%)
Agitation
67 (.34%)
Coma
64 (.33%)
Tremor
64 (.33%)
Insomnia
63 (.32%)
Renal Failure
63 (.32%)
Renal Failure Acute
63 (.32%)
Abdominal Pain Upper
62 (.32%)
Pulmonary Oedema
62 (.32%)
Tachycardia
61 (.31%)
Heart Rate Increased
60 (.31%)
Drug Dependence
59 (.3%)
Aspartate Aminotransferase Increase...
58 (.3%)
Atrial Fibrillation
57 (.29%)
Pneumonia
57 (.29%)
Lethargy
56 (.29%)
Unresponsive To Stimuli
54 (.28%)
Arthralgia
53 (.27%)
Blood Creatinine Increased
53 (.27%)
Cerebrovascular Accident
53 (.27%)
Anxiety
52 (.26%)
Chest Pain
52 (.26%)
Decreased Appetite
52 (.26%)
Condition Aggravated
51 (.26%)
Urticaria
51 (.26%)
International Normalised Ratio Incr...
49 (.25%)
Jaundice
48 (.24%)
Oedema Peripheral
48 (.24%)
Abdominal Distension
47 (.24%)
Drug Abuser
47 (.24%)
Pancreatitis Acute
47 (.24%)
Substance Abuse
47 (.24%)
Suicidal Ideation
47 (.24%)
Syncope
47 (.24%)
Weight Decreased
47 (.24%)
Blood Pressure Increased
46 (.23%)
Muscle Spasms
46 (.23%)
Myalgia
46 (.23%)
Hypoxia
45 (.23%)
Musculoskeletal Stiffness
45 (.23%)
Delirium
44 (.22%)
Pain In Extremity
44 (.22%)
Miosis
43 (.22%)
Gamma-glutamyltransferase Increased
42 (.21%)
Hepatic Failure
42 (.21%)
Mental Status Changes
42 (.21%)

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

What are the most common Codeine Sulfate adverse events reported to the FDA?

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

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

Pain
2044
Drug Use For Unknown Indication
1806
Product Used For Unknown Indication
1228
Cough
679
Back Pain
419
Migraine
211
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Rheumatoid Arthritis
192
Arthralgia
189
Headache
173
Analgesic Therapy
168
Osteoarthritis
119
Diarrhoea
112
Arthritis
102
Musculoskeletal Pain
72
Abdominal Pain
63
Ill-defined Disorder
61
Pain In Extremity
60
Bronchitis
56
Procedural Pain
53
Fibromyalgia
52
Cancer Pain
48
Neck Pain
45
Analgesia
45
Muscle Spasms
42
Drug Exposure During Pregnancy
41
Sciatica
40
Suicide Attempt
40
Toothache
38
Pain Management
34
Crohns Disease
34
Analgesic Effect
33
Upper Respiratory Tract Infection
33
Bone Pain
32
Antitussive Therapy
28
Chest Pain
28
Neuralgia
27
Breakthrough Pain
27
Foetal Exposure During Pregnancy
26
Nasopharyngitis
25
Symphysiolysis
24
Pharyngitis Streptococcal
23
Pyrexia
19
Postoperative Analgesia
19
Pneumonia
19
Ankylosing Spondylitis
18
Post Herpetic Neuralgia
18
Bronchitis Chronic
18
Prophylaxis
17
Insomnia
17
Intentional Overdose
17
Premedication
15

Drug Labels

LabelLabelerEffective
Codeine SulfatePhysicians Total Care, Inc.22-OCT-09
Codeine SulfateLannett Company, Inc.15-JAN-10
Codeine SulfateTAGI Pharma, Inc.28-MAR-12
Codeine SulfateRoxane Laboratories, Inc27-SEP-12

Codeine Sulfate Case Reports

What Codeine Sulfate 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 Codeine Sulfate. 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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