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Levothroid (Levothyroxine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Levothroid (Levothyroxine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (33)
Death (5)
Life Threatening Events (5)
Disability (6)

Reports by Reaction Type

Blood Pressure Increased (8)Hypertensive Crisis (7)Drug Ineffective (6)Dyspnoea (6)Labile Hypertension (5)Urinary Incontinence (5)Headache (5)Overdose (5)Completed Suicide (5)Cough (5)Blood Potassium Increased (5)Bronchitis (5)

Below are a few examples of reports where side effects / adverse reactions may be related to Levothroid (Levothyroxine). For a complete list or a specific selection of reports, please use the links above.

Possible Levothroid side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient:

Reactions: Vitamin D Deficiency, Polymyalgia Rheumatica, Femur Fracture, Palpitations, Adverse Event, Cardiac Failure Congestive, Chondropathy, Bowel Movement Irregularity, Pain in Extremity, Anaemia, Coronary Artery Disease, Hallucination, Visual, Aspartate Aminotransferase Increased, Ventricular Tachycardia, Stress Fracture, Drug Ineffective, Restless Legs Syndrome, Fall, Gastric Ulcer, Hypercholesterolaemia, Depression, Acute Myocardial Infarction, RIB Fracture, Decreased Appetite, Supraventricular Extrasystoles, Nausea, Urinary Tract Infection, Hyponatraemia, Post Herpetic Neuralgia, Meniscus Lesion, Anxiety, Feeling Abnormal, Hypertension, Leukocytosis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Fosamax
    Dosage: 70 mg, unk
    Administration route: Oral
    Start date: 2006-02-22
    End date: 2010-06-18

Alendronate Sodium
    Dosage: 70 mg/kg, unk
    Start date: 2009-11-21

Fosamax
    Dosage: 70 mg, unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2001-01-08
    End date: 2004-12-01

Levothroid
    Dosage: unk
    Indication: Hypothyroidism
    Start date: 1950-01-01

Other drugs received by patient: Benicar; Zocor; Sinemet



Possible Levothroid side effects in 78 year old female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 78 year old female, weighing 77.6 kg (170.7 pounds)

Reactions: Basedow's Disease, Pain in Extremity, Breast Disorder, Breast Mass, Osteopenia, Cataract Cortical, Hyperlipidaemia, Osteoarthritis, Hypothyroidism, Thyroid Disorder, Essential Hypertension, Hypertension

Drug(s) suspected as cause:
Aspirin
    Administration route: Oral

Levothyroxine Sodium

Prilosec
    Administration route: Oral

Crestor
    Administration route: Oral

Levothroid

Crestor
    Administration route: Oral

Cardizem CD



Possible Levothroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous, Infertility

Drug(s) suspected as cause:
Levothroid
    Dosage: 50 mcg
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2011-05-01
    End date: 2012-06-01

Levothroid
    Dosage: 150 mcg
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-06-27



Possible Levothroid side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 53 year old female

Reactions: Cardiac Flutter, Amnesia, Lethargy

Drug(s) suspected as cause:
Levothroid
    Dosage: 75 mcg
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2005-01-01

Levothroid
    Dosage: 75 mcg monday-saturday

Other drugs received by patient: Vitamin B-12; Vitamin D; Aspirin; Lisinopril; Ginkgo; M.v.i.; Vitamin E; Fish OIL; Ascorbic Acid



Possible Levothroid side effects in 54 year old male

Reported by a physician from United States on 2012-07-03

Patient: 54 year old male, weighing 95.0 kg (209.0 pounds)

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Cytomel
    Dosage: 100 mcg
    Indication: Generalised Resistance To Thyroid Hormone

Levothroid
    Dosage: 200 mcg
    Indication: Generalised Resistance To Thyroid Hormone

Other drugs received by patient: Albuterol; Verapamil; Theophylline; Terazosin HCL



Possible Levothroid side effects in female

Reported by a pharmacist from United States on 2012-07-02

Patient: female, weighing 62.6 kg (137.7 pounds)

Reactions: Platelet Count Decreased

Drug(s) suspected as cause:
Cardizem CD
    Dosage: 180 mg, daily

Levothroid
    Dosage: 0.075 mg, daily
    Indication: Thyroid Disorder

Aspirin
    Dosage: 81 mg, daily
    Indication: Cardiac Failure Congestive

Xanax
    Dosage: 0.25 mg, as needed
    Indication: Anxiety

Atrovent
    Dosage: 0.5 mg, as needed
    Indication: Chronic Obstructive Pulmonary Disease

Budesonide
    Dosage: 0.25 mg, 2x/day
    Indication: Chronic Obstructive Pulmonary Disease

Zyvox
    Dosage: 600 mg, every 12 hours
    Indication: Pneumonia
    Start date: 2012-06-17

Celexa
    Dosage: 20 mg, daily
    Indication: Depression

Other drugs received by patient: Oxygen



Possible Levothroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: female

Reactions: Dyspnoea, Hyperhidrosis, Tremor, Irritability, Anxiety, Menstrual Disorder, Diarrhoea, Insomnia, Heart Rate Increased, Nervousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levothroid



Possible Levothroid side effects in 70 year old female

Reported by a physician from Spain on 2012-06-12

Patient: 70 year old female

Reactions: Eyelid Oedema, Arthralgia, Oedema Peripheral, Drug Interaction

Drug(s) suspected as cause:
Sycrest (Asenapine / 05706901 / ) 95 MG)
    Dosage: 5 mg; bid; sl, 5 mg; qd; sl
    Indication: Bipolar Disorder
    Start date: 2012-05-01
    End date: 2012-05-01

Levothroid
    Indication: Hypothyroidism

Other drugs received by patient: Simvastatin; Lithium



Possible Levothroid side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-31

Patient: female, weighing 136.0 kg (299.2 pounds)

Reactions: Drug Level Fluctuating, Off Label Use, Thyroid Function Test Abnormal, Cardiac Disorder, Arrhythmia

Drug(s) suspected as cause:
Levothroid



Possible Levothroid side effects in 45 year old female

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: 45 year old female, weighing 79.4 kg (174.6 pounds)

Reactions: Disease Complication, Anxiety, Irritability, Hyperhidrosis, Nervousness

Drug(s) suspected as cause:
Levothroid



Possible Levothroid side effects in female

Reported by a physician from United States on 2012-05-11

Patient: female

Reactions: Bipolar Disorder, Dizziness, Feeling Abnormal

Drug(s) suspected as cause:
Levothroid

Vitamin D

Xanax
    Start date: 2010-01-01

Atrovent

Calcium



Possible Levothroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-24

Patient: female

Reactions: Drug Level Fluctuating, Product Formulation Issue, Product Quality Issue, Arrhythmia

Drug(s) suspected as cause:
Levothroid

Synthroid
    Dosage: 0.150 mg 1 per day ?
    Indication: Autoimmune Thyroiditis



Possible Levothroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-17

Patient: female

Reactions: Bipolar Disorder, Dizziness, Feeling Abnormal

Drug(s) suspected as cause:
Levothroid
    Dosage: unk

Calcium
    Dosage: unk

Vitamin D
    Dosage: unk

Atrovent
    Dosage: unk

Xanax
    Dosage: unk
    Start date: 2010-01-01



Possible Levothroid side effects in 57 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-05

Patient: 57 year old female, weighing 77.6 kg (170.6 pounds)

Reactions: Product Substitution Issue, Liver Function Test Abnormal, Blood Cholesterol Increased, Bradycardia, Thyroid Function Test Abnormal

Drug(s) suspected as cause:
Levothroid



Possible Levothroid side effects in 51 year old male

Reported by a physician from United States on 2012-04-04

Patient: 51 year old male

Reactions: Colon Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clonidine
    Indication: Product Used FOR Unknown Indication

Levothroid
    Indication: Product Used FOR Unknown Indication

Norvasc
    Dosage: 5 mg (5 mg, 1 in 1 d)
    Indication: Product Used FOR Unknown Indication

Trazodone HCL
    Indication: Product Used FOR Unknown Indication

Benazepril Hydrochloride
    Indication: Product Used FOR Unknown Indication

Ambien
    Indication: Product Used FOR Unknown Indication

Pravastatin
    Indication: Product Used FOR Unknown Indication



Possible Levothroid side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: male

Reactions: Colon Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benazepril Hydrochloride

Levothroid
    Dosage: unk

Ambien
    Dosage: unk

Pravastatin

Clonidine
    Dosage: unk

Norvasc
    Dosage: 5 mg, 1x/day (1 tablet daily)

Trazodone HCL
    Dosage: unk



Possible Levothroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-28

Patient: female

Reactions: Blood Pressure Increased, Electrocardiogram Abnormal, Dizziness

Drug(s) suspected as cause:
Levothroid



Possible Levothroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: female, weighing 65.4 kg (143.9 pounds)

Reactions: Blood Pressure Increased, Dyspnoea, Labile Hypertension, Drug Ineffective, Urinary Incontinence, Blood Potassium Increased, Headache, Hypertensive Crisis, Overdose, Bronchitis, Cough, Atrioventricular Block First Degree

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Labetalol
    Dosage: 1 df, qid

Levothroid
    Dosage: 600 ug, unk
    Administration route: Oral

Levothroid
    Dosage: 300 ug, unk
    Administration route: Oral

Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2011-06-06
    End date: 2011-11-04

Labetalol
    Dosage: 1 df, q6h
    Administration route: Oral

Catapres
    Dosage: 0.1 mg, tid (prn)
    Administration route: Oral

Zestril
    Dosage: 10 mg, bid

Labetalol
    Dosage: 900 mg, once/single
    Administration route: Oral

Lopressor
    Dosage: 50 mg, tid
    Administration route: Oral

Catapres
    Dosage: 0.1 mg, tid (prn)
    Administration route: Oral

Cardizem LA
    Dosage: unk ukn, unk
    Indication: Coronary Artery Disease

Other drugs received by patient: Synthroid; Aldactone; Amitiza; Clonidine; Aldactone; Prozac; Prilosec; Vitamin D; Valium; Dyazide; Valium



Possible Levothroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: female, weighing 65.4 kg (143.9 pounds)

Reactions: Blood Pressure Increased, Dyspnoea, Labile Hypertension, Drug Ineffective, Urinary Incontinence, Blood Potassium Increased, Headache, Hypertensive Crisis, Overdose, Bronchitis, Cough, Atrioventricular Block First Degree

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Levothroid
    Dosage: 300 ug, unk
    Administration route: Oral

Levothroid
    Dosage: 600 ug, unk
    Administration route: Oral

Catapres
    Dosage: 0.1 mg, tid (prn)
    Administration route: Oral

Labetalol HCL
    Dosage: 1 df, q6h
    Administration route: Oral

Catapres
    Dosage: 0.1 mg, tid (prn)
    Administration route: Oral

Labetalol HCL
    Dosage: 1 df, qid

Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2011-06-06
    End date: 2011-11-04

Lopressor
    Dosage: 50 mg, tid
    Administration route: Oral

Cardizem LA
    Dosage: unk ukn, unk
    Indication: Coronary Artery Disease

Labetalol HCL
    Dosage: 900 mg, once/single
    Administration route: Oral

Zestril
    Dosage: 10 mg, bid

Other drugs received by patient: Prozac; Vitamin D; Synthroid; Aldactone; Valium; Valium; Prilosec; Clonidine; Aldactone; Dyazide; Amitiza



Possible Levothroid side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-09

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Mental Impairment, Weight Increased, Dysarthria, Gait Disturbance

Drug(s) suspected as cause:
Levothroid
    Start date: 2008-06-01
    End date: 2010-03-01

Synthroid
    Dosage: 75 mcg
    Start date: 2010-03-01

Synthroid
    Dosage: 50 mcg
    Start date: 2008-04-01
    End date: 2008-06-01

Other drugs received by patient: Naproxen; Iron; Lexapro



Possible Levothroid side effects in 51 year old male

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient: 51 year old male

Reactions: Colon Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ambien
    Indication: Product Used FOR Unknown Indication

Norvasc
    Dosage: 5 mg (5 mg, 1 in 1 d)
    Indication: Product Used FOR Unknown Indication

Trazodone HCL
    Indication: Product Used FOR Unknown Indication

Levothroid
    Indication: Product Used FOR Unknown Indication

Pravastatin
    Indication: Product Used FOR Unknown Indication

Benazepril Hydrochloride
    Indication: Product Used FOR Unknown Indication

Clonidine
    Indication: Product Used FOR Unknown Indication



Possible Levothroid side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-10

Patient: male

Reactions: Colon Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ambien
    Dosage: unk

Benazepril Hydrochloride

Norvasc
    Dosage: 5 mg, 1x/day (1 tablet daily)

Pravastatin

Levothroid
    Dosage: unk

Clonidine
    Dosage: unk

Trazodone HCL
    Dosage: unk



Possible Levothroid side effects in 58 year old female

Reported by a physician from United States on 2012-01-17

Patient: 58 year old female

Reactions: Cardio-Respiratory Arrest, Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Antihyperlipidemic (Nos) (Antihyperlipidemic (Nos))

Levothroid

Calcium Antagoinst (Nos) (Calcium Antagonist (Nos))

Cardiac Glycoside (Nos) (Cardiac Glycoside (Nos))

Diphenhydramine HCL

Benzodiazepine (Nos) (Benzoediazepine (Nos)

Carprofen (Carprofen)



Possible Levothroid side effects in 87 year old female

Reported by a physician from United States on 2012-01-17

Patient: 87 year old female

Reactions: Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Nitroglycerin

Colchicine

Metoprolol Succinate Extended Release

Hydralazine HCL

Levothroid

Zolpidem

Alprazolam

Acetaminophen / Propoxyphene (Acetaminophen, Propoxyphene)



Possible Levothroid side effects in 74 year old female

Reported by a physician from United States on 2012-01-17

Patient: 74 year old female

Reactions: Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Risperidone

Levothroid

Simvastatin

Temazepam

Bumetanide

Hypocholorite (Sodium Hypochlorite)

Potassium Chloride

Carvedilol

Clopidogrel

Lisinopril



Possible Levothroid side effects in 51 year old female

Reported by a physician from United States on 2012-01-17

Patient: 51 year old female

Reactions: Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Levothroid

Beta Blocker (Nos) (Beta Blocker (Nos))

Benzodiazepine (Nos) (Benzosiazepine)

Bupropion HCL



Possible Levothroid side effects in 53 year old female

Reported by a physician from United States on 2012-01-13

Patient: 53 year old female

Reactions: Completed Suicide, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Fentanyl
    Dosage: transdermal

Acetaminophen and Oxycodone HCL

Acetaminophen and Hydrocodone Bitartrate

Zolpidem

Carisoprodol

Alprazolam

Levothroid

Tolterodine Tartrate



Possible Levothroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-09

Patient: female, weighing 65.4 kg (143.9 pounds)

Reactions: Blood Pressure Increased, Dyspnoea, Drug Ineffective, Labile Hypertension, Urinary Incontinence, Blood Potassium Increased, Headache, Hypertensive Crisis, Overdose, Bronchitis, Atrioventricular Block First Degree, Cough

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Labetalol HCL
    Dosage: 1 df, qid

Lopressor
    Dosage: 50 mg, tid
    Administration route: Oral

Labetalol HCL
    Dosage: 1 df, q6h
    Administration route: Oral

Catapres
    Dosage: 0.1 mg, tid (prn)
    Administration route: Oral

Zestril
    Dosage: 10 mg, bid

Levothroid
    Dosage: 300 ug, unk
    Administration route: Oral

Cardizem LA
    Dosage: unk ukn, unk
    Indication: Coronary Artery Disease

Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2001-06-06
    End date: 2011-11-04

Labetalol HCL
    Dosage: 900 mg, once/single
    Administration route: Oral

Catapres
    Dosage: 0.1 mg, tid (prn)
    Administration route: Oral

Gilenya
    Indication: Demyelination

Levothroid
    Dosage: 600 ug, unk
    Administration route: Oral

Other drugs received by patient: Synthroid; Valium; Prilosec; Prozac; Aldactone; Amitiza; Valium; Aldactone; Dyazide; Clonidine; Vitamin D



Possible Levothroid side effects in female

Reported by a physician from United States on 2012-01-09

Patient: female, weighing 65.4 kg (143.9 pounds)

Reactions: Blood Pressure Increased, Dyspnoea, Labile Hypertension, Drug Ineffective, Urinary Incontinence, Blood Potassium Increased, Headache, Hypertensive Crisis, Overdose, Bronchitis, Atrioventricular Block First Degree, Cough

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Lopressor
    Dosage: 50 mg, tid
    Administration route: Oral

Labetalol HCL
    Dosage: 1 df, q6h
    Administration route: Oral

Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2001-06-06
    End date: 2011-11-04

Gilenya
    Indication: Demyelination

Levothroid
    Dosage: 600 ug, unk
    Administration route: Oral

Levothroid
    Dosage: 300 ug, unk
    Administration route: Oral

Labetalol HCL
    Dosage: 900 mg, once/single
    Administration route: Oral

Labetalol HCL
    Dosage: 1 df, qid

Cardizem LA
    Dosage: unk ukn, unk
    Indication: Coronary Artery Disease

Clonidine
    Dosage: 0.1 mg, tid (prn)
    Administration route: Oral

Clonidine
    Dosage: 0.1 mg, tid (prn)
    Administration route: Oral

Zestril
    Dosage: 10 mg, bid

Other drugs received by patient: Prozac; Amitiza; Synthroid; Valium; Dyazide; Aldactone; Valium; Prilosec; Clonidine; Vitamin D; Aldactone



Possible Levothroid side effects in female

Reported by a physician from United States on 2012-01-09

Patient: female, weighing 65.4 kg (143.9 pounds)

Reactions: Blood Pressure Increased, Dyspnoea, Labile Hypertension, Drug Ineffective, Urinary Incontinence, Blood Potassium Increased, Headache, Hypertensive Crisis, Overdose, Bronchitis, Atrioventricular Block First Degree, Cough

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Lopressor
    Dosage: 50 mg, tid
    Administration route: Oral

Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2001-06-06
    End date: 2011-11-04

Levothroid
    Dosage: 300 ug, unk
    Administration route: Oral

Labetalol HCL
    Dosage: 900 mg, once/single
    Administration route: Oral

Labetalol HCL
    Dosage: 1 df, qid

Gilenya
    Indication: Demyelination

Labetalol HCL
    Dosage: 1 df, q6h
    Administration route: Oral

Cardizem LA
    Dosage: unk ukn, unk
    Indication: Coronary Artery Disease

Levothroid
    Dosage: 600 ug, unk
    Administration route: Oral

Catapres
    Dosage: 0.1 mg, tid (prn)
    Administration route: Oral

Zestril
    Dosage: 10 mg, bid

Catapres
    Dosage: 0.1 mg, tid (prn)
    Administration route: Oral

Other drugs received by patient: Amitiza; Prozac; Dyazide; Clonidine; Vitamin D; Aldactone; Aldactone; Valium; Synthroid; Valium; Prilosec

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