STADOL

Adverse Events

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Stadol Adverse Events Reported to the FDA Over Time

How are Stadol adverse event reports trending over time?

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

Most Common Stadol Adverse Events Reported to the FDA

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

Dependence	269 (27.25%)
Drug Withdrawal Syndrome	70 (7.09%)
Drug Ineffective	41 (4.15%)
Nausea	21 (2.13%)
Dizziness	16 (1.62%)
Anxiety	12 (1.22%)
Vomiting	11 (1.11%)
Feeling Abnormal	10 (1.01%)
Headache	10 (1.01%)
Depression	9 (.91%)
Dyspnoea	9 (.91%)
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Pregnancy	9 (.91%)
Product Quality Issue	9 (.91%)
Product Taste Abnormal	9 (.91%)
Drug Dependence	8 (.81%)
Drug Hypersensitivity	8 (.81%)
Dysgeusia	7 (.71%)
Hallucination	7 (.71%)
Hyperhidrosis	7 (.71%)
Pruritus	7 (.71%)
Somnolence	7 (.71%)
Abnormal Behaviour	6 (.61%)
Heart Rate Increased	6 (.61%)
Nasal Discomfort	6 (.61%)
Product Odour Abnormal	6 (.61%)
Dental Caries	5 (.51%)
Drug Abuse	5 (.51%)
Dysarthria	5 (.51%)
Tooth Abscess	5 (.51%)
Vision Blurred	5 (.51%)
Blood Pressure Increased	4 (.41%)
Drug Exposure During Pregnancy	4 (.41%)
Drug Screen False Positive	4 (.41%)
Gait Disturbance	4 (.41%)
Muscular Weakness	4 (.41%)
Normal Newborn	4 (.41%)
Overdose	4 (.41%)
Tremor	4 (.41%)
Anaphylactic Shock	3 (.3%)
Angina Pectoris	3 (.3%)
Blood Pressure Decreased	3 (.3%)
Cardiac Disorder	3 (.3%)
Chest Pain	3 (.3%)
Cough	3 (.3%)
Drug Interaction	3 (.3%)
Fatigue	3 (.3%)
Feeling Hot	3 (.3%)
Flushing	3 (.3%)
Hypersensitivity	3 (.3%)
Hypertension	3 (.3%)
Hypoventilation	3 (.3%)
Injury	3 (.3%)
Nasal Congestion	3 (.3%)
Pain	3 (.3%)
Paranoia	3 (.3%)
Paraplegia	3 (.3%)
Partner Stress	3 (.3%)
Prostatic Disorder	3 (.3%)
Pulse Absent	3 (.3%)
Rash	3 (.3%)
Respiratory Depression	3 (.3%)
Rhinalgia	3 (.3%)
Sinusitis	3 (.3%)
Throat Irritation	3 (.3%)
Tinnitus	3 (.3%)
Tooth Loss	3 (.3%)
Abdominal Discomfort	2 (.2%)
Agitation	2 (.2%)
Asthenia	2 (.2%)
Atelectasis	2 (.2%)
Back Injury	2 (.2%)
Blood Glucose Increased	2 (.2%)
Burning Sensation	2 (.2%)
Cleft Lip And Palate	2 (.2%)
Cold Sweat	2 (.2%)
Condition Aggravated	2 (.2%)
Confusional State	2 (.2%)
Cyanosis	2 (.2%)
Death	2 (.2%)
Decreased Appetite	2 (.2%)
Depressed Level Of Consciousness	2 (.2%)
Device Malfunction	2 (.2%)
Disorientation	2 (.2%)
Drug Abuser	2 (.2%)
Dry Mouth	2 (.2%)
Ectopic Pregnancy	2 (.2%)
Emotional Disorder	2 (.2%)
Epistaxis	2 (.2%)
Euphoric Mood	2 (.2%)
Hypertelorism Of Orbit	2 (.2%)
Hypertonia	2 (.2%)
Inadequate Analgesia	2 (.2%)
Increased Upper Airway Secretion	2 (.2%)
Influenza Like Illness	2 (.2%)
Lacrimation Increased	2 (.2%)
Malaise	2 (.2%)
Maternal Drugs Affecting Foetus	2 (.2%)
Medication Error	2 (.2%)
Medication Residue	2 (.2%)
Microencephaly	2 (.2%)
Migraine	2 (.2%)

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

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

Psychiatric	284 (28.77%)
Therapeutic And Nontherapeutic Effe...	115 (11.65%)
Neurological	58 (5.88%)
Product Quality Issues	42 (4.26%)
Respiratory	38 (3.85%)
Gastrointestinal Signs	37 (3.75%)
Cardiac And Vascular Investigations	20 (2.03%)
Infections - Pathogen Unspecified	16 (1.62%)
Allergic Conditions	15 (1.52%)
Anxiety Disorders	15 (1.52%)
Medication Errors	15 (1.52%)
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Epidermal And Dermal Conditions	14 (1.42%)
Headaches	13 (1.32%)
Pregnancy, Labour, Delivery And Pos...	13 (1.32%)
Movement Disorders	10 (1.01%)
Muscle	10 (1.01%)
Skin Appendage Conditions	10 (1.01%)
Depressed Mood Disorders	9 (.91%)
Upper Respiratory Tract Disorders	9 (.91%)
Dental And Gingival Conditions	8 (.81%)
Injuries	8 (.81%)
Cardiac Disorder Signs	7 (.71%)
Disturbances In Thinking	7 (.71%)
Mood Disorders	7 (.71%)
Toxicology And Therapeutic Drug Mon...	7 (.71%)
Chemical Injury And Poisoning	6 (.61%)
Inner Ear And Viiith Cranial Nerve	6 (.61%)
Psychiatric And Behavioural Symptom...	6 (.61%)
Vision	6 (.61%)
Procedural And Device Related Injur...	5 (.51%)
Vascular	5 (.51%)
Administration Site Reactions	4 (.41%)
Cardiac Arrhythmias	4 (.41%)
Deliria	4 (.41%)
Lifestyle Issues	4 (.41%)
Personality Disorders	4 (.41%)
Physical Examination Topics	4 (.41%)
Suicidal And Self-injurious Behavio...	4 (.41%)
Coronary Artery	3 (.3%)
Decreased And Nonspecific Blood Pre...	3 (.3%)
Eye	3 (.3%)
Family Issues	3 (.3%)
Maternal Complications Of Pregnancy	3 (.3%)
Mental Impairment	3 (.3%)
Metabolic, Nutritional And Blood Ga...	3 (.3%)
Ocular Neuromuscular	3 (.3%)
Prostatic Disorders	3 (.3%)
Salivary Gland Conditions	3 (.3%)
Seizures	3 (.3%)
Vascular Hypertensive	3 (.3%)
Appetite And General Nutritional	2 (.2%)
Bone Disorders	2 (.2%)
Fatal Outcomes	2 (.2%)
Gastrointestinal Tract Disorders Co...	2 (.2%)
Glucose Metabolism Disorders	2 (.2%)
Hearing	2 (.2%)
Lower Respiratory Tract Disorders	2 (.2%)
Musculoskeletal And Connective Tiss...	2 (.2%)
Musculoskeletal And Connective Tiss...	2 (.2%)
Musculoskeletal And Connective Tiss...	2 (.2%)
Neonatal And Perinatal Conditions	2 (.2%)
Neurological Disorders Congenital	2 (.2%)
Neuromuscular	2 (.2%)
Sexual Function And Fertility	2 (.2%)
Sleep Disorders	2 (.2%)
Tissue	2 (.2%)
Urinary Tract Signs	2 (.2%)
Angiedema And Urticaria	1 (.1%)
Aural	1 (.1%)
Bronchial Disorders	1 (.1%)
Central Nervous System Vascular	1 (.1%)
Changes In Physical Activity	1 (.1%)
Chromosomal Abnormalities And Abnor...	1 (.1%)
Communication Disorders	1 (.1%)
Congenital And Hereditary	1 (.1%)
Cranial Nerve Disorders	1 (.1%)
Electrolyte And Fluid Balance Condi...	1 (.1%)
Endocrine Investigations	1 (.1%)
Exocrine Pancreas Conditions	1 (.1%)
Fetal Complications	1 (.1%)
Gastrointestinal Motility And Defec...	1 (.1%)
Joint	1 (.1%)
Neonatal Respiratory	1 (.1%)
Obstetric And Gynecological Therape...	1 (.1%)
Ocular Sensory Symptoms	1 (.1%)
Oral Soft Tissue Conditions	1 (.1%)
Renal And Urinary Tract Investigati...	1 (.1%)
Renal Disorders	1 (.1%)
Sleep Disturbances	1 (.1%)
Vascular Hemorrhagic	1 (.1%)

Share/Embed Graph Export Data

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

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

Migraine	484
Pain	117
Headache	115
Back Pain	30
Abdominal Pain	17
Product Used For Unknown Indication	9
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Labour Pain	8
Sinus Disorder	6
Sedation	6
Drug Use For Unknown Indication	5
Insomnia	5
Induction Of Anaesthesia	5
Pruritus	4
Migraine Without Aura	4
Analgesia	4
Tension Headache	4
Sickle Cell Anaemia	3
Analgesic Therapy	3
Anaesthesia Procedure	3
Anaesthesia	3
Neck Pain	3
Surgery	3
Articular Disc Disorder	2
Head Injury	2
Myalgia	2
Pain In Extremity	2
Flank Pain	2
Premature Labour	2
Back Disorder	2
Epidural Anaesthesia	2
Pancreatitis Chronic	2
Back Injury	2
Sinus Headache	2
Migraine Prophylaxis	2
Facial Pain	2
Foetal Exposure During Pregnancy	2
Drug Withdrawal Syndrome	1
Arthralgia	1
Fibromyalgia	1
Muscle Spasms	1
Crohns Disease	1
Systemic Lupus Erythematosus	1
Chest Wall Pain	1
Postoperative Analgesia	1
Haematuria	1
Injury	1
Spinal Fusion Surgery	1
Dyskinesia Oesophageal	1
Analgesic Effect	1
Anxiety	1
Trigeminal Neuralgia	1

Stadol Case Reports

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

About Results

This report contains aggregated drug side effects and adverse events for Stadol. 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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