LORTAB

Adverse Events

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Lortab Adverse Events Reported to the FDA Over Time

How are Lortab adverse event reports trending over time?

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

Most Common Lortab Adverse Events Reported to the FDA

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

Completed Suicide	3163 (10.83%)
Cardiac Arrest	1147 (3.93%)
Cardio-respiratory Arrest	1116 (3.82%)
Respiratory Arrest	1110 (3.8%)
Intentional Drug Misuse	680 (2.33%)
Death	566 (1.94%)
Drug Abuse	544 (1.86%)
Drug Toxicity	464 (1.59%)
Multiple Drug Overdose	421 (1.44%)
Nausea	371 (1.27%)
Drug Ineffective	369 (1.26%)
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Vomiting	320 (1.1%)
Poisoning	299 (1.02%)
Overdose	291 (1%)
Somnolence	250 (.86%)
Pain	232 (.79%)
Multiple Drug Overdose Intentional	223 (.76%)
Confusional State	197 (.67%)
Headache	190 (.65%)
Depression	173 (.59%)
Dizziness	173 (.59%)
Constipation	172 (.59%)
Anxiety	168 (.58%)
Fall	168 (.58%)
Medication Error	160 (.55%)
Dyspnoea	152 (.52%)
Insomnia	143 (.49%)
Hypotension	140 (.48%)
Loss Of Consciousness	134 (.46%)
Malaise	133 (.46%)
Mental Status Changes	130 (.45%)
Drug Abuser	124 (.42%)
Feeling Abnormal	123 (.42%)
Abdominal Pain	119 (.41%)
Pruritus	119 (.41%)
Coma	118 (.4%)
Drug Interaction	117 (.4%)
Hallucination	114 (.39%)
Unresponsive To Stimuli	114 (.39%)
Drug Dependence	112 (.38%)
Intentional Overdose	107 (.37%)
Asthenia	103 (.35%)
Diarrhoea	101 (.35%)
Aspartate Aminotransferase Increase...	100 (.34%)
Drug Screen Positive	100 (.34%)
Fatigue	100 (.34%)
Lethargy	97 (.33%)
Back Pain	96 (.33%)
Pain In Extremity	96 (.33%)
Agitation	94 (.32%)
Chest Pain	94 (.32%)
Suicidal Ideation	94 (.32%)
Convulsion	90 (.31%)
Alanine Aminotransferase Increased	89 (.3%)
Memory Impairment	89 (.3%)
Heart Rate Increased	87 (.3%)
Accidental Overdose	86 (.29%)
Incorrect Dose Administered	86 (.29%)
Abdominal Pain Upper	83 (.28%)
Depressed Level Of Consciousness	83 (.28%)
Pulmonary Oedema	81 (.28%)
Hypertension	80 (.27%)
Drug Hypersensitivity	77 (.26%)
Rash	77 (.26%)
Pneumonia	74 (.25%)
Arthralgia	73 (.25%)
Drug Effect Decreased	73 (.25%)
Suicide Attempt	71 (.24%)
Hyperhidrosis	69 (.24%)
Multiple Drug Overdose Accidental	69 (.24%)
Nervousness	69 (.24%)
Product Substitution Issue	68 (.23%)
Amnesia	67 (.23%)
Oedema Peripheral	64 (.22%)
Blood Glucose Increased	62 (.21%)
Tremor	62 (.21%)
Drug Withdrawal Syndrome	61 (.21%)
Weight Decreased	61 (.21%)
Accidental Death	59 (.2%)
Dehydration	59 (.2%)
Pyrexia	58 (.2%)
Respiratory Depression	58 (.2%)
Gait Disturbance	57 (.2%)
Product Quality Issue	56 (.19%)
Pulmonary Congestion	56 (.19%)
Blood Pressure Decreased	55 (.19%)
Condition Aggravated	54 (.18%)
Wrong Technique In Drug Usage Proce...	54 (.18%)
Disorientation	51 (.17%)
Muscle Spasms	51 (.17%)
Road Traffic Accident	51 (.17%)
Abnormal Dreams	50 (.17%)
Dysuria	50 (.17%)
Urinary Tract Infection	50 (.17%)
Decreased Appetite	49 (.17%)
Sedation	49 (.17%)
Hypoaesthesia	47 (.16%)
Tachycardia	47 (.16%)
Withdrawal Syndrome	47 (.16%)
Delirium	46 (.16%)
Pneumonia Aspiration	46 (.16%)

Share/Embed Graph Export Data

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

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

Suicidal And Self-injurious Behavio...	3360 (11.5%)
Cardiac Arrhythmias	2505 (8.58%)
Medication Errors	1702 (5.83%)
Respiratory	1670 (5.72%)
Psychiatric	1605 (5.49%)
Neurological	1493 (5.11%)
Gastrointestinal Signs	1095 (3.75%)
Chemical Injury And Poisoning	875 (3%)
Therapeutic And Nontherapeutic Effe...	791 (2.71%)
Fatal Outcomes	666 (2.28%)
Injuries	509 (1.74%)
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Anxiety Disorders	400 (1.37%)
Infections - Pathogen Unspecified	361 (1.24%)
Epidermal And Dermal Conditions	349 (1.19%)
Cardiac And Vascular Investigations	322 (1.1%)
Gastrointestinal Motility And Defec...	312 (1.07%)
Musculoskeletal And Connective Tiss...	305 (1.04%)
Lifestyle Issues	301 (1.03%)
Deliria	295 (1.01%)
Hepatobiliary	294 (1.01%)
Sleep Disorders	275 (.94%)
Mental Impairment	255 (.87%)
Lower Respiratory Tract Disorders	234 (.8%)
Metabolic, Nutritional And Blood Ga...	233 (.8%)
Headaches	231 (.79%)
Hepatic And Hepatobiliary	217 (.74%)
Disturbances In Thinking	215 (.74%)
Depressed Mood Disorders	211 (.72%)
Hematology Investigations	208 (.71%)
Physical Examination Topics	194 (.66%)
Toxicology And Therapeutic Drug Mon...	193 (.66%)
Muscle	190 (.65%)
Joint	179 (.61%)
Urinary Tract Signs	171 (.59%)
Decreased And Nonspecific Blood Pre...	167 (.57%)
Product Quality Issues	158 (.54%)
Water, Electrolyte And Mineral	153 (.52%)
Electrolyte And Fluid Balance Condi...	142 (.49%)
Allergic Conditions	140 (.48%)
Appetite And General Nutritional	132 (.45%)
Renal Disorders	121 (.41%)
Mood Disorders	117 (.4%)
Skin Appendage Conditions	115 (.39%)
Renal And Urinary Tract Investigati...	111 (.38%)
Personality Disorders	110 (.38%)
Cardiac Disorder Signs	108 (.37%)
Procedural And Device Related Injur...	105 (.36%)
Bone And Joint Injuries	101 (.35%)
Movement Disorders	101 (.35%)
Seizures	101 (.35%)
Central Nervous System Vascular	98 (.34%)
Bacterial Infectious	91 (.31%)
Vision	91 (.31%)
Ocular Neuromuscular	90 (.31%)
Enzyme	89 (.3%)
Vascular Hypertensive	87 (.3%)
Coronary Artery	83 (.28%)
Encephalopathies	82 (.28%)
Gastrointestinal Hemorrhages	78 (.27%)
Body Temperature Conditions	75 (.26%)
Myocardial	72 (.25%)
Musculoskeletal And Connective Tiss...	67 (.23%)
Angiedema And Urticaria	66 (.23%)
Bronchial Disorders	62 (.21%)
Acid-base	59 (.2%)
Dental And Gingival Conditions	57 (.2%)
Legal Issues	57 (.2%)
Lipid Analyses	53 (.18%)
Upper Respiratory Tract Disorders	51 (.17%)
Coagulopathies And Bleeding Diathes...	48 (.16%)
Therapeutic Procedures And Supporti...	48 (.16%)
Oral Soft Tissue Conditions	47 (.16%)
Peripheral Neuropathies	47 (.16%)
Embolism And Thrombosis	45 (.15%)
Gastrointestinal Conditions	44 (.15%)
Gastrointestinal Stenosis And Obstr...	44 (.15%)
Administration Site Reactions	43 (.15%)
Glucose Metabolism Disorders	43 (.15%)
Inner Ear And Viiith Cranial Nerve	43 (.15%)
Arteriosclerosis, Stenosis, Vascula...	42 (.14%)
Psychiatric And Behavioural Symptom...	42 (.14%)
Viral Infectious	42 (.14%)
Salivary Gland Conditions	41 (.14%)
Bone Disorders	40 (.14%)
Heart Failures	39 (.13%)
Pleural	39 (.13%)
Anemias Nonhemolytic And Marrow Dep...	38 (.13%)
Pulmonary Vascular	38 (.13%)
Changes In Physical Activity	37 (.13%)
Increased Intracranial Pressure And...	35 (.12%)
Demyelinating	33 (.11%)
Gallbladder	33 (.11%)
Sleep Disturbances	32 (.11%)
Hearing	31 (.11%)
Tissue	31 (.11%)
Exocrine Pancreas Conditions	30 (.1%)
Ovarian And Fallopian Tube	29 (.1%)
Vascular	29 (.1%)
Eye	28 (.1%)
Adrenal Gland	27 (.09%)
Fungal Infectious	27 (.09%)

Share/Embed Graph Export Data

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

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

Pain	6274
Drug Use For Unknown Indication	2730
Product Used For Unknown Indication	2661
Back Pain	937
Breakthrough Pain	436
Arthralgia	355
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Arthritis	205
Rheumatoid Arthritis	179
Fibromyalgia	177
Pain In Extremity	164
Headache	142
Analgesic Therapy	142
Migraine	124
Abdominal Pain	117
Pain Management	110
Neck Pain	110
Ill-defined Disorder	96
Osteoarthritis	92
Musculoskeletal Pain	91
Suicide Attempt	90
Back Disorder	62
Cough	59
Procedural Pain	56
Analgesic Effect	44
Neuralgia	38
Intervertebral Disc Protrusion	36
Completed Suicide	33
Cancer Pain	32
Intervertebral Disc Degeneration	31
Bone Pain	30
Back Injury	30
Myalgia	29
Crohns Disease	28
Joint Injury	27
Neuropathy Peripheral	27
Drug Abuse	21
Toothache	21
Sciatica	19
Foetal Exposure During Pregnancy	18
Intentional Drug Misuse	17
Abdominal Pain Upper	17
Spinal Column Stenosis	16
Dental Operation	16
Postoperative Analgesia	15
Herpes Zoster	15
Dysmenorrhoea	15
Pain In Jaw	15
Nasopharyngitis	14
Musculoskeletal Chest Pain	14
Muscle Spasms	13
Sleep Disorder	13

Drug Labels

Label	Labeler	Effective
Lortab	STAT RX USA LLC	21-JUL-10
Lortab	Cardinal Health	07-DEC-10
Lortab	Physicians Total Care, Inc.	07-DEC-10
Lortab	Cardinal Health	07-DEC-10
Lortab	Physicians Total Care, Inc.	07-DEC-10
Lortab	Physicians Total Care, Inc.	07-DEC-10
Lortab	Physicians Total Care, Inc.	25-MAR-11
Lortab	UCB, Inc.	14-JUL-11
Lortab	UCB, Inc.	15-JUL-11
Lortab	UCB, Inc.	19-JUL-11
Lortab	UCB, Inc.	19-JUL-11
Lortab	Cardinal Health	19-APR-12
Lortab	A-S Medication Solutions LLC	27-FEB-13
Lortab	A-S Medication Solutions LLC	02-MAR-13

Lortab Case Reports

What Lortab 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 Lortab. 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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