LEVOTHYROXINE

Levothyroxine Adverse Events Reported to the FDA Over Time

How are Levothyroxine adverse event reports trending over time?

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

Most Common Levothyroxine Adverse Events Reported to the FDA

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

Fatigue	1224 (2.53%)
Alopecia	842 (1.74%)
Weight Increased	720 (1.49%)
Drug Ineffective	709 (1.47%)
Headache	665 (1.37%)
Blood Thyroid Stimulating Hormone I...	652 (1.35%)
Palpitations	642 (1.33%)
Dizziness	610 (1.26%)
Insomnia	579 (1.2%)
Feeling Abnormal	541 (1.12%)
Dyspnoea	533 (1.1%)
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Nausea	506 (1.05%)
Asthenia	484 (1%)
Malaise	468 (.97%)
Drug Interaction	436 (.9%)
Anxiety	433 (.89%)
Pruritus	430 (.89%)
Diarrhoea	409 (.85%)
Rash	403 (.83%)
Weight Decreased	384 (.79%)
Hypothyroidism	375 (.78%)
Thyroid Function Test Abnormal	373 (.77%)
Hyperthyroidism	333 (.69%)
Tremor	330 (.68%)
Heart Rate Increased	328 (.68%)
Hyperhidrosis	319 (.66%)
Blood Thyroid Stimulating Hormone D...	318 (.66%)
Completed Suicide	288 (.6%)
Blood Pressure Increased	275 (.57%)
Chest Pain	274 (.57%)
Hypersensitivity	267 (.55%)
Blood Thyroid Stimulating Hormone A...	262 (.54%)
Oedema Peripheral	262 (.54%)
Constipation	257 (.53%)
Pain	256 (.53%)
Muscle Spasms	255 (.53%)
Hypertension	252 (.52%)
Urticaria	250 (.52%)
Myalgia	249 (.51%)
Arthralgia	248 (.51%)
Depression	247 (.51%)
Vomiting	243 (.5%)
Nervousness	225 (.47%)
Pain In Extremity	220 (.45%)
Somnolence	220 (.45%)
Product Substitution Issue	196 (.41%)
Fall	193 (.4%)
Muscular Weakness	179 (.37%)
Atrial Fibrillation	177 (.37%)
Overdose	174 (.36%)
Dyspepsia	172 (.36%)
Abdominal Pain Upper	170 (.35%)
Coeliac Disease	168 (.35%)
Gait Disturbance	168 (.35%)
Hypotension	168 (.35%)
Dry Skin	167 (.35%)
Abdominal Pain	161 (.33%)
Paraesthesia	161 (.33%)
Pyrexia	151 (.31%)
Cough	150 (.31%)
Loss Of Consciousness	149 (.31%)
Chest Discomfort	148 (.31%)
Feeling Cold	147 (.3%)
Abdominal Distension	145 (.3%)
Tachycardia	145 (.3%)
Dysgeusia	144 (.3%)
Confusional State	142 (.29%)
Agitation	141 (.29%)
Abdominal Discomfort	140 (.29%)
Hypoaesthesia	138 (.29%)
Swelling Face	138 (.29%)
Oral Discomfort	137 (.28%)
Drug Effect Decreased	134 (.28%)
Irritability	134 (.28%)
Medication Error	134 (.28%)
Erythema	132 (.27%)
Product Quality Issue	132 (.27%)
Memory Impairment	131 (.27%)
Anaemia	129 (.27%)
Decreased Appetite	129 (.27%)
Dysphagia	128 (.26%)
Feeling Jittery	125 (.26%)
Dry Mouth	124 (.26%)
Renal Failure Acute	122 (.25%)
Drug Exposure During Pregnancy	117 (.24%)
Incorrect Dose Administered	117 (.24%)
Thyroid Disorder	117 (.24%)
Flushing	115 (.24%)
Cerebrovascular Accident	114 (.24%)
Drug Dispensing Error	113 (.23%)
Condition Aggravated	111 (.23%)
Death	111 (.23%)
Burning Sensation	108 (.22%)
Convulsion	106 (.22%)
Back Pain	104 (.21%)
Hot Flush	104 (.21%)
Lethargy	104 (.21%)
Blood Glucose Increased	97 (.2%)
Suicide Attempt	97 (.2%)
Cardiac Arrest	96 (.2%)
Dehydration	95 (.2%)

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

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

Neurological	2464 (5.09%)
Epidermal And Dermal Conditions	2197 (4.54%)
Endocrine Investigations	1938 (4.01%)
Gastrointestinal Signs	1893 (3.91%)
Therapeutic And Nontherapeutic Effe...	1633 (3.38%)
Skin Appendage Conditions	1509 (3.12%)
Respiratory	1497 (3.09%)
Physical Examination Topics	1216 (2.51%)
Medication Errors	1092 (2.26%)
Cardiac And Vascular Investigations	1048 (2.17%)
Cardiac Arrhythmias	982 (2.03%)
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Anxiety Disorders	976 (2.02%)
Muscle	959 (1.98%)
Thyroid Gland	916 (1.89%)
Gastrointestinal Motility And Defec...	832 (1.72%)
Sleep Disorders	756 (1.56%)
Headaches	749 (1.55%)
Cardiac Disorder Signs	731 (1.51%)
Infections - Pathogen Unspecified	616 (1.27%)
Movement Disorders	595 (1.23%)
Musculoskeletal And Connective Tiss...	579 (1.2%)
Allergic Conditions	498 (1.03%)
Joint	488 (1.01%)
Injuries	466 (.96%)
Suicidal And Self-injurious Behavio...	442 (.91%)
Product Quality Issues	440 (.91%)
Hematology Investigations	403 (.83%)
Mental Impairment	384 (.79%)
Electrolyte And Fluid Balance Condi...	354 (.73%)
Appetite And General Nutritional	346 (.72%)
Decreased And Nonspecific Blood Pre...	332 (.69%)
Depressed Mood Disorders	330 (.68%)
Renal Disorders	328 (.68%)
Oral Soft Tissue Conditions	315 (.65%)
Angiedema And Urticaria	305 (.63%)
Chemical Injury And Poisoning	303 (.63%)
Vascular	294 (.61%)
Vascular Hypertensive	279 (.58%)
Mood Disorders	272 (.56%)
Vision	254 (.52%)
Central Nervous System Vascular	253 (.52%)
Hepatic And Hepatobiliary	248 (.51%)
Metabolic, Nutritional And Blood Ga...	241 (.5%)
Deliria	216 (.45%)
Urinary Tract Signs	213 (.44%)
Bone Disorders	211 (.44%)
Malabsorption Conditions	204 (.42%)
Eye	200 (.41%)
Hepatobiliary	200 (.41%)
Water, Electrolyte And Mineral	183 (.38%)
Seizures	178 (.37%)
Coronary Artery	176 (.36%)
Upper Respiratory Tract Disorders	176 (.36%)
Toxicology And Therapeutic Drug Mon...	169 (.35%)
Anemias Nonhemolytic And Marrow Dep...	167 (.35%)
Body Temperature Conditions	167 (.35%)
Lifestyle Issues	164 (.34%)
Inner Ear And Viiith Cranial Nerve	159 (.33%)
Psychiatric	154 (.32%)
Fatal Outcomes	153 (.32%)
Bone And Joint Injuries	151 (.31%)
Menstrual Cycle And Uterine Bleedin...	144 (.3%)
Salivary Gland Conditions	136 (.28%)
Disturbances In Thinking	130 (.27%)
Lipid Analyses	129 (.27%)
Bronchial Disorders	128 (.26%)
Gastrointestinal Conditions	128 (.26%)
Glucose Metabolism Disorders	125 (.26%)
Investigations, Imaging And Histopa...	124 (.26%)
White Blood Cell	123 (.25%)
Renal And Urinary Tract Investigati...	121 (.25%)
Personality Disorders	116 (.24%)
Heart Failures	113 (.23%)
Tongue Conditions	111 (.23%)
Cardiac Valve	109 (.23%)
Sleep Disturbances	108 (.22%)
Gastrointestinal Hemorrhages	102 (.21%)
Bacterial Infectious	101 (.21%)
Lower Respiratory Tract Disorders	101 (.21%)
Therapeutic Procedures And Supporti...	97 (.2%)
Enzyme	96 (.2%)
Gastrointestinal Inflammatory Condi...	95 (.2%)
Endocrine Neoplasms Malignant And U...	91 (.19%)
Viral Infectious	89 (.18%)
Arteriosclerosis, Stenosis, Vascula...	86 (.18%)
Vascular Hemorrhagic	86 (.18%)
Dental And Gingival Conditions	82 (.17%)
Ocular Infections, Irritations And ...	82 (.17%)
Breast	79 (.16%)
Skin Vascular Abnormalities	79 (.16%)
Peripheral Neuropathies	78 (.16%)
Neuromuscular	77 (.16%)
Psychiatric And Behavioural Symptom...	73 (.15%)
Acid-base	71 (.15%)
Hearing	71 (.15%)
Myocardial	71 (.15%)
Embolism And Thrombosis	70 (.14%)
Changes In Physical Activity	68 (.14%)
Gastrointestinal Ulceration And Per...	67 (.14%)
Abortions And Stillbirth	64 (.13%)
Platelet	63 (.13%)

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This graph shows the top categories of adverse events submitted to the FDA for Levothyroxine, 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 Levothyroxine 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.