SYNTHROID

Synthroid Adverse Events Reported to the FDA Over Time

How are Synthroid adverse event reports trending over time?

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

Most Common Synthroid Adverse Events Reported to the FDA

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

Fatigue	866 (2.36%)
Alopecia	592 (1.62%)
Blood Thyroid Stimulating Hormone I...	513 (1.4%)
Headache	503 (1.37%)
Dizziness	467 (1.28%)
Palpitations	464 (1.27%)
Weight Increased	448 (1.22%)
Drug Ineffective	420 (1.15%)
Nausea	392 (1.07%)
Insomnia	385 (1.05%)
Dyspnoea	384 (1.05%)
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Feeling Abnormal	373 (1.02%)
Drug Interaction	368 (1%)
Asthenia	355 (.97%)
Malaise	321 (.88%)
Pruritus	313 (.85%)
Anxiety	311 (.85%)
Diarrhoea	299 (.82%)
Rash	291 (.79%)
Hypothyroidism	268 (.73%)
Weight Decreased	265 (.72%)
Completed Suicide	242 (.66%)
Tremor	242 (.66%)
Thyroid Function Test Abnormal	238 (.65%)
Hyperhidrosis	219 (.6%)
Hypertension	218 (.6%)
Heart Rate Increased	208 (.57%)
Blood Thyroid Stimulating Hormone A...	207 (.57%)
Chest Pain	207 (.57%)
Hyperthyroidism	201 (.55%)
Depression	200 (.55%)
Pain	196 (.54%)
Vomiting	192 (.52%)
Blood Thyroid Stimulating Hormone D...	190 (.52%)
Blood Pressure Increased	188 (.51%)
Urticaria	183 (.5%)
Muscle Spasms	181 (.49%)
Product Substitution Issue	179 (.49%)
Oedema Peripheral	178 (.49%)
Pain In Extremity	177 (.48%)
Constipation	175 (.48%)
Arthralgia	174 (.48%)
Fall	173 (.47%)
Myalgia	166 (.45%)
Somnolence	165 (.45%)
Hypersensitivity	155 (.42%)
Atrial Fibrillation	151 (.41%)
Overdose	151 (.41%)
Nervousness	149 (.41%)
Hypotension	143 (.39%)
Coeliac Disease	141 (.38%)
Pyrexia	134 (.37%)
Abdominal Pain Upper	127 (.35%)
Muscular Weakness	127 (.35%)
Abdominal Pain	126 (.34%)
Loss Of Consciousness	124 (.34%)
Renal Failure Acute	120 (.33%)
Gait Disturbance	119 (.32%)
Confusional State	118 (.32%)
Product Quality Issue	118 (.32%)
Cough	111 (.3%)
Dry Skin	110 (.3%)
Cerebrovascular Accident	109 (.3%)
Death	109 (.3%)
Tachycardia	109 (.3%)
Dyspepsia	108 (.29%)
Paraesthesia	108 (.29%)
Abdominal Discomfort	107 (.29%)
Medication Error	106 (.29%)
Decreased Appetite	105 (.29%)
Anaemia	101 (.28%)
Dysgeusia	100 (.27%)
Chest Discomfort	99 (.27%)
Drug Exposure During Pregnancy	99 (.27%)
Incorrect Dose Administered	98 (.27%)
Irritability	98 (.27%)
Abdominal Distension	95 (.26%)
Agitation	95 (.26%)
Hypoaesthesia	92 (.25%)
Drug Effect Decreased	88 (.24%)
Dry Mouth	88 (.24%)
Condition Aggravated	85 (.23%)
Feeling Cold	85 (.23%)
Therapeutic Response Unexpected Wit...	85 (.23%)
Thyroid Disorder	85 (.23%)
Erythema	83 (.23%)
Blood Glucose Increased	82 (.22%)
Dehydration	82 (.22%)
Drug Dispensing Error	82 (.22%)
Convulsion	81 (.22%)
Cardiac Arrest	80 (.22%)
Memory Impairment	80 (.22%)
Suicide Attempt	79 (.22%)
Hot Flush	77 (.21%)
Renal Failure	76 (.21%)
Syncope	76 (.21%)
Flushing	74 (.2%)
Back Pain	73 (.2%)
International Normalised Ratio Incr...	73 (.2%)
Swelling Face	73 (.2%)
Burning Sensation	72 (.2%)

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

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

Neurological	1837 (5.02%)
Epidermal And Dermal Conditions	1599 (4.37%)
Endocrine Investigations	1375 (3.75%)
Gastrointestinal Signs	1365 (3.73%)
Therapeutic And Nontherapeutic Effe...	1154 (3.15%)
Respiratory	1051 (2.87%)
Skin Appendage Conditions	1037 (2.83%)
Medication Errors	899 (2.45%)
Cardiac Arrhythmias	822 (2.24%)
Physical Examination Topics	796 (2.17%)
Cardiac And Vascular Investigations	765 (2.09%)
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Muscle	705 (1.92%)
Anxiety Disorders	696 (1.9%)
Thyroid Gland	634 (1.73%)
Gastrointestinal Motility And Defec...	588 (1.61%)
Headaches	570 (1.56%)
Infections - Pathogen Unspecified	543 (1.48%)
Cardiac Disorder Signs	528 (1.44%)
Sleep Disorders	498 (1.36%)
Movement Disorders	427 (1.17%)
Musculoskeletal And Connective Tiss...	427 (1.17%)
Injuries	410 (1.12%)
Product Quality Issues	388 (1.06%)
Suicidal And Self-injurious Behavio...	368 (1%)
Hematology Investigations	362 (.99%)
Joint	359 (.98%)
Allergic Conditions	340 (.93%)
Electrolyte And Fluid Balance Condi...	302 (.82%)
Renal Disorders	300 (.82%)
Decreased And Nonspecific Blood Pre...	288 (.79%)
Appetite And General Nutritional	264 (.72%)
Chemical Injury And Poisoning	258 (.7%)
Depressed Mood Disorders	258 (.7%)
Central Nervous System Vascular	241 (.66%)
Mental Impairment	234 (.64%)
Angiedema And Urticaria	233 (.64%)
Vascular Hypertensive	231 (.63%)
Hepatic And Hepatobiliary	220 (.6%)
Mood Disorders	216 (.59%)
Metabolic, Nutritional And Blood Ga...	208 (.57%)
Vascular	205 (.56%)
Deliria	187 (.51%)
Vision	185 (.51%)
Hepatobiliary	171 (.47%)
Malabsorption Conditions	171 (.47%)
Bone Disorders	166 (.45%)
Coronary Artery	155 (.42%)
Water, Electrolyte And Mineral	153 (.42%)
Toxicology And Therapeutic Drug Mon...	152 (.42%)
Body Temperature Conditions	148 (.4%)
Fatal Outcomes	148 (.4%)
Seizures	147 (.4%)
Oral Soft Tissue Conditions	146 (.4%)
Urinary Tract Signs	145 (.4%)
Anemias Nonhemolytic And Marrow Dep...	136 (.37%)
Bone And Joint Injuries	134 (.37%)
Psychiatric	134 (.37%)
Upper Respiratory Tract Disorders	131 (.36%)
Lifestyle Issues	125 (.34%)
White Blood Cell	120 (.33%)
Glucose Metabolism Disorders	116 (.32%)
Eye	112 (.31%)
Renal And Urinary Tract Investigati...	109 (.3%)
Inner Ear And Viiith Cranial Nerve	105 (.29%)
Lipid Analyses	104 (.28%)
Heart Failures	103 (.28%)
Cardiac Valve	99 (.27%)
Gastrointestinal Conditions	96 (.26%)
Salivary Gland Conditions	96 (.26%)
Bacterial Infectious	94 (.26%)
Disturbances In Thinking	93 (.25%)
Enzyme	93 (.25%)
Lower Respiratory Tract Disorders	93 (.25%)
Bronchial Disorders	90 (.25%)
Gastrointestinal Hemorrhages	88 (.24%)
Therapeutic Procedures And Supporti...	88 (.24%)
Menstrual Cycle And Uterine Bleedin...	86 (.23%)
Personality Disorders	86 (.23%)
Endocrine Neoplasms Malignant And U...	82 (.22%)
Gastrointestinal Inflammatory Condi...	82 (.22%)
Investigations, Imaging And Histopa...	82 (.22%)
Vascular Hemorrhagic	78 (.21%)
Tongue Conditions	73 (.2%)
Dental And Gingival Conditions	72 (.2%)
Skin Vascular Abnormalities	70 (.19%)
Arteriosclerosis, Stenosis, Vascula...	69 (.19%)
Breast	69 (.19%)
Embolism And Thrombosis	69 (.19%)
Peripheral Neuropathies	69 (.19%)
Acid-base	65 (.18%)
Myocardial	65 (.18%)
Viral Infectious	65 (.18%)
Hearing	64 (.17%)
Neuromuscular	64 (.17%)
Platelet	61 (.17%)
Psychiatric And Behavioural Symptom...	60 (.16%)
Breast Neoplasms Malignant And Unsp...	59 (.16%)
Ocular Infections, Irritations And ...	59 (.16%)
Neonatal And Perinatal Conditions	56 (.15%)
Sleep Disturbances	56 (.15%)
Abortions And Stillbirth	55 (.15%)

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