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Synthroid (Levothyroxine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Synthroid (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 (860)
Death (15)
Life Threatening Events (13)
Disability (8)

Reports by Reaction Type

Alopecia (86)Fatigue (83)Headache (57)Drug Ineffective (51)Blood Thyroid Stimulating Hormone Increased (49)Weight Increased (49)Feeling Abnormal (49)Dizziness (47)Palpitations (46)Anxiety (46)Coeliac Disease (44)Insomnia (43)

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

Possible Synthroid side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 52 year old female, weighing 50.8 kg (111.7 pounds)

Reactions: Psychomotor Hyperactivity, Pain, Neck Injury, Fall, Joint Injury, Incorrect Drug Administration Duration, Feeling Abnormal, Hyperthyroidism, Back Injury, RIB Fracture

Drug(s) suspected as cause:
Calcium Carbonate
    Dosage: 1200 mg, 1x/day
    Indication: Mineral Supplementation

Nicotrol
    Dosage: unk
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2011-01-01

Synthroid
    Dosage: unk
    Indication: Hypothyroidism
    End date: 2012-01-01

Synthroid
    Dosage: 88 ug, unk
    Start date: 2012-01-01



Possible Synthroid side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 67 year old female, weighing 78.9 kg (173.6 pounds)

Reactions: Confusional State, Nasopharyngitis, Weight Loss Poor, DRY Skin, Thyroxine Increased, Constipation, Weight Increased, Respiratory Tract Congestion, Mood Altered, TRI-Iodothyronine Decreased, Alopecia, Insomnia, Onychoclasis, Disturbance in Attention, Memory Impairment

Drug(s) suspected as cause:
Levoxyl
    Dosage: 100 ug, daily

Levoxyl
    Dosage: 50 ug, unk
    Indication: Hypothyroidism

Synthroid
    Dosage: unk
    Indication: Hypothyroidism



Possible Synthroid side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-22

Patient: female, weighing 73.0 kg (160.6 pounds)

Reactions: Cataract, Hypersensitivity, Glaucoma, Pain in Extremity, Headache, Femoral Artery Embolism, Peripheral Embolism, Malaise, Skin Discolouration, Heart Rate Increased, DRY Mouth, Blood Cholesterol Increased, Vasodilatation, Feeling Abnormal, Hypertension

Adverse event resulted in: hospitalization

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

Levothyroxine Sodium
    Indication: Product Used FOR Unknown Indication

Synthroid
    Indication: Hypothyroidism

Synthroid
    Administration route: Oral
    Start date: 2007-01-01

Other drugs received by patient: Propafenone HCL; Eparema; Timolol Maleate; Dimethicone; Dramin B6



Possible Synthroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female, weighing 62.7 kg (137.8 pounds)

Reactions: Coeliac Disease, Palpitations, Drug Interaction, Haematoma

Drug(s) suspected as cause:
Synthroid
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2011-01-01

Synthroid
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2011-01-01

Other drugs received by patient possibly interacting with the suspect drug:
Epinephrine
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Synthroid
    Indication: Hypothyroidism
    Start date: 2000-01-01
    End date: 2011-01-01

Other drugs received by patient: Loestrin 1.5 / 30



Possible Synthroid side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 54 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Visual Impairment, Hypothyroidism, Condition Aggravated

Drug(s) suspected as cause:
Estring
    Dosage: unk, once in three months
    Indication: Vulvovaginal Dryness
    Start date: 2011-10-01

Synthroid
    Dosage: 125 ug, 1x/day
    Administration route: Oral
    Start date: 2012-06-01

Synthroid
    Dosage: 112 ug, 1x/day
    Administration route: Oral
    Indication: Hypothyroidism
    End date: 2012-06-01

Other drugs received by patient: Benicar



Possible Synthroid side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 54 year old female

Reactions: Fatigue, Dysphonia, Oropharyngeal Pain, Tremor, Thyroid Function Test Abnormal

Drug(s) suspected as cause:
Liothyronine Sodium
    Dosage: unk
    Indication: Thyroid Hormone Replacement Therapy

Synthroid
    Dosage: unk
    Indication: Thyroid Hormone Replacement Therapy

Xanax
    Dosage: unk
    Indication: Anxiety



Possible Synthroid side effects in 68 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-14

Patient: 68 year old female

Reactions: Meniscus Lesion, Anxiety, Panic Attack, Pain in Extremity, Thyroid Disorder, Breast Cancer Female, Gastrooesophageal Reflux Disease

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

Lexapro

Nexium
    Administration route: Oral

Synthroid

Other drugs received by patient: Arimidex



Possible Synthroid side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: female

Reactions: Multiple Sclerosis

Drug(s) suspected as cause:
Synthroid



Possible Synthroid side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 81 year old female, weighing 61.2 kg (134.6 pounds)

Reactions: Weight Decreased, Pain, Chills, Drug Interaction, Headache, Pyrexia, Abdominal Pain Upper, Malaise, Fatigue, Oedema Peripheral, DRY Mouth, Dizziness, Muscle Spasms, Blood Pressure Increased, Vein Disorder, Nausea, Paraesthesia, Anxiety, Panic Attack, Insomnia, Vision Blurred, Gait Disturbance, Influenza

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin
    Dosage: 81 mg, 1 d
    Indication: Hypertension

Fish OIL (Fish Oil)
    Indication: Product Used FOR Unknown Indication

Hydrocodone Bitartrate
    Dosage: 350 mg, as needed (one or two times)
    Indication: Spinal Cord Disorder

Lisinopril
    Dosage: 30 mg (10 mg, 3 in 1 d)
    Indication: Hypertension

Lovastatin
    Dosage: 20 mg, d
    Indication: Blood Cholesterol

Lyrica
    Dosage: 50 mg, 1 d, oral
    Administration route: Oral
    Indication: Vein Pain
    Start date: 2012-07-26
    End date: 2012-07-28

Multivitamin
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Oxybutynin Chloride
    Dosage: 10 mg
    Indication: Hypertonic Bladder

Rivastigmine Tartrate
    Indication: Dementia

Synthroid
    Dosage: 50 mcg, 1 d
    Indication: Thyroid Disorder

Xanax
    Dosage: 1 mg, as required)
    Indication: Panic Attack



Possible Synthroid side effects in male

Reported by a physician from United States on 2012-08-09

Patient: male

Reactions: Urticaria, Vocal Cord Disorder

Drug(s) suspected as cause:
Revlimid
    Dosage: 15 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2010-01-18

Synthroid
    Dosage: 175 microgram



Possible Synthroid side effects in 48 year old female

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

Patient: 48 year old female, weighing 57.2 kg (125.7 pounds)

Reactions: Product Substitution Issue, Bedridden, Respiratory Disorder, Pain, Autoimmune Thyroiditis, TRI-Iodothyronine Decreased, Fibromyalgia, Intervertebral Disc Disorder, Crying, Product Quality Issue, Inadequate Analgesia, Organ Failure, Heart Rate Increased, Gait Disturbance, Thyroid Neoplasm, Arthritis, Iodine Deficiency

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Levothyroxine Sodium
    Dosage: all 1x day oral
    Administration route: Oral
    Start date: 2007-01-01

Synthroid
    Dosage: all 1x day pill
    Indication: Thyroidectomy
    Start date: 2004-01-01
    End date: 2008-01-01



Possible Synthroid side effects in female

Reported by a physician from United States on 2012-08-07

Patient: female, weighing 65.1 kg (143.2 pounds)

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Synthroid
    End date: 2012-05-31

Synthroid
    Indication: Hypothyroidism
    Start date: 1997-05-01



Possible Synthroid side effects in female

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

Patient: female, weighing 59.0 kg (129.7 pounds)

Reactions: Alopecia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Levothyroxine Sodium
    Dosage: 0.025mg tabs 1 x day by mouth
    Administration route: Oral
    Indication: Hypothyroidism

Synthroid
    Dosage: 0.025mg tabs 1 x day by mouth
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2011-07-16
    End date: 2012-07-16



Possible Synthroid side effects in female

Reported by a pharmacist from United States on 2012-08-06

Patient: female, weighing 77.6 kg (170.7 pounds)

Reactions: Cellulitis, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synthroid

Other drugs received by patient: Mediciation FOR Migraines; Metformin Hydrochloride



Possible Synthroid side effects in female

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

Patient: female, weighing 91.0 kg (200.2 pounds)

Reactions: Lyme Disease

Drug(s) suspected as cause:
Cortef
    Dosage: 20 mg in morning, 5mg at 2pm
    Administration route: Oral
    Indication: Hypopituitarism
    Start date: 2009-01-01

Hydrocortisone
    Dosage: 20 mg in morning and 5mg at 2pm
    Administration route: Oral
    Indication: Hypopituitarism
    Start date: 2009-01-01

Levothyroxine Sodium
    Dosage: 50 ug, 1x/day
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2009-01-01

Synthroid
    Dosage: 50 ug, 1x/day
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2009-01-01

Other drugs received by patient: Calcium Carbonate / Ergocalciferol; Albuterol; Theophylline; Zyrtec; Fluticasone Propionate; Alpha Lipoic Acid; Iron; Coenzyme Q10; Lactobacillus Acidophilus; Diflucan



Possible Synthroid side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-01

Patient: female, weighing 68.5 kg (150.7 pounds)

Reactions: Product Substitution Issue, Laboratory Test Abnormal

Drug(s) suspected as cause:
Synthroid



Possible Synthroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: female, weighing 62.2 kg (136.8 pounds)

Reactions: Brain Neoplasm Benign, Weight Increased, Feeling of Despair, Fatigue, Heart Rate Decreased, Alopecia, Dizziness

Drug(s) suspected as cause:
Synthroid
    End date: 2012-02-01

Synthroid
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-02-01

Synthroid
    Start date: 2012-02-01

Synthroid

Other drugs received by patient: Reclast



Possible Synthroid side effects in female

Reported by a physician from United States on 2012-07-31

Patient: female

Reactions: Breast Cancer, Constipation, Feeling Cold, Anxiety, Irritability, Fatigue, Hypothyroidism, Fluid Retention

Drug(s) suspected as cause:
Synthroid
    Dosage: not reported dose
    Indication: Hypothyroidism
    Start date: 1987-01-01

Synthroid
    Dosage: ^certain pills^ to make 112.5 mcg daily

Synthroid
    Dosage: 1-100mcg tablet + 1/2-25 mcg tablet

Synthroid
    Dosage: ^certain pills^ to make 112.5 mcg daily

Synthroid
    Dosage: ^certain pills^ to make 112.5 mcg daily

Synthroid
    Dosage: 1-100mcg tablet + 1/2-25 mcg tablet



Possible Synthroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Madarosis, Drug Ineffective

Drug(s) suspected as cause:
Latisse
    Dosage: 2 gtt, qhs
    Administration route: Topical
    Indication: Hypotrichosis
    Start date: 2011-08-01

Synthroid
    Dosage: 112 a?g, qd
    Administration route: Oral
    Indication: Thyroid Disorder
    Start date: 2006-01-01



Possible Synthroid side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 47 year old female, weighing 139.7 kg (307.4 pounds)

Reactions: Drug Dose Omission, Product Quality Issue, Blood Thyroid Stimulating Hormone Increased, Paraesthesia, Muscle Spasms

Drug(s) suspected as cause:
Levothyroxine Sodium
    Dosage: 1 tablet daily 2 on sunday po
    Administration route: Oral
    Indication: Thyroid Hormone Replacement Therapy
    Start date: 2012-04-05
    End date: 2012-07-25

Levothyroxine Sodium
    Dosage: 1 tablet daily 2 on sunday po
    Administration route: Oral
    Indication: Thyroidectomy
    Start date: 2012-04-05
    End date: 2012-07-25

Synthroid



Possible Synthroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: female, weighing 82.6 kg (181.8 pounds)

Reactions: Uterine Cancer, Poor Quality Drug Administered

Drug(s) suspected as cause:
Synthroid

Other drugs received by patient: Metformin Hydrochloride



Possible Synthroid side effects in 51 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 51 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Depression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cogentin

Cymbalta

Klonopin

Seroquel XR
    Administration route: Oral
    Indication: Bipolar II Disorder

Seroquel XR
    Administration route: Oral
    Indication: Depression

Synthroid

Wellbutrin



Possible Synthroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: female, weighing 110.3 kg (242.7 pounds)

Reactions: Endometriosis, Blood Thyroid Stimulating Hormone Decreased, Uterine Enlargement, Thyroxine Increased, Thinking Abnormal, Hot Flush, Dizziness, Temperature Intolerance, Asthenia, Polycystic Ovaries

Drug(s) suspected as cause:
Synthroid
    Indication: Thyroidectomy
    Start date: 1971-01-01
    End date: 2012-07-17

Synthroid
    Start date: 2012-07-17

Other drugs received by patient: Unknown Medications



Possible Synthroid side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: 62 year old female

Reactions: Drug Dose Omission, Blood Pressure Abnormal, Memory Impairment

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral

Synthroid



Possible Synthroid side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: female, weighing 58.0 kg (127.7 pounds)

Reactions: Product Quality Issue, Mucous Stools, Constipation

Drug(s) suspected as cause:
Levoxyl
    Dosage: one and a half tablet, 1x/day
    Administration route: Oral
    Indication: Autoimmune Thyroiditis
    Start date: 2011-02-01
    End date: 2012-07-01

Levoxyl
    Dosage: one and a half tablet, 1x/day
    Start date: 2012-04-01

Synthroid
    Dosage: unk
    Start date: 2011-01-01
    End date: 2011-02-01



Possible Synthroid side effects in 38 year old female

Reported by a physician from United Kingdom on 2012-07-25

Patient: 38 year old female

Reactions: Galactorrhoea, Blood Prolactin Increased, Pituitary Tumour Benign

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

Cellcept
    Indication: Product Used FOR Unknown Indication

Elavil
    Indication: Product Used FOR Unknown Indication

Fosamax
    Indication: Product Used FOR Unknown Indication

Neurontin
    Indication: Product Used FOR Unknown Indication

Plaquenil
    Indication: Product Used FOR Unknown Indication

Prednisone
    Indication: Product Used FOR Unknown Indication

Risperidone
    Indication: Depression
    Start date: 2011-09-01

Synthroid
    Indication: Product Used FOR Unknown Indication

Zocor
    Indication: Product Used FOR Unknown Indication



Possible Synthroid side effects in female

Reported by a physician from United States on 2012-07-24

Patient: female

Reactions: Thyroid Cancer, Neoplasm Malignant, Muscle Spasms

Drug(s) suspected as cause:
Gleevec
    Dosage: 300 mg,
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia

Synthroid
    Dosage: 88 mg, daily
    Administration route: Oral
    Indication: Thyroid Disorder

Other drugs received by patient: Ultimate EYE Support; Pantoprazole; Aspirin; Multi-Vitamin; Metamucil-2; Metoprolol Tartrate; Calcium Carbonate



Possible Synthroid side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24

Patient: female

Reactions: Back Pain, Impaired Work Ability

Drug(s) suspected as cause:
Fluoxetine
    Dosage: 20 mg, 1x/day
    Administration route: Oral

Neurontin
    Dosage: 300 mg, 3x/day
    Administration route: Oral

Synthroid
    Dosage: 125 ug, 1x/day
    Administration route: Oral

Valium
    Dosage: 10 mg, 3x/day
    Administration route: Oral



Possible Synthroid side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-24

Patient: female, weighing 64.0 kg (140.8 pounds)

Reactions: Weight Decreased, Abdominal Pain, Blood Cholesterol Abnormal, Vomiting, Pain, Anaemia, Gastrointestinal Carcinoma, Pyrexia, Blood Triglycerides Abnormal, Endometrial Neoplasm, Abdominal Pain Upper, Rash Macular, Diarrhoea, Visual Impairment, Memory Impairment, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chemotherapeutics
    Dosage: every 20 days
    Indication: Gastrointestinal Carcinoma

Chemotherapeutics
    Administration route: Oral

Synthroid
    Dosage: 1 in 1 day, in the morning
    Administration route: Oral
    Indication: Hypothyroidism

Synthroid
    Dosage: 1 in 1 day, in the morning
    Administration route: Oral

Synthroid
    Dosage: 1 in 1 day, in the morning
    Administration route: Oral

Other drugs received by patient: Alendronate Sodium; Aspirin; Caltrate D; Caltrate D



Possible Synthroid side effects in female

Reported by a physician from United States on 2012-07-23

Patient: female

Reactions: Expired Drug Administered, Atrial Fibrillation, Blood Thyroid Stimulating Hormone Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synthroid
    Dosage: 150 mcg daily
    Indication: Product Used FOR Unknown Indication

Synthroid
    Dosage: 125 mcg daily

Synthroid
    Dosage: 175 mcg daily
    Indication: Thyroidectomy

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