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Tirosint (Levothyroxine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tirosint (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 (14)

Reports by Reaction Type

Heart Rate Increased (4)Abdominal Discomfort (3)Malaise (3)Feeling Abnormal (3)Asthenia (3)Abdominal Pain (2)Thirst (2)Palpitations (2)Coeliac Disease (2)Chest Pain (2)Abdominal Distension (2)Dizziness (2)

Possible Tirosint side effects in 57 year old female

Reported by a physician from United States on 2012-07-20

Patient: 57 year old female

Reactions: Malaise, Polymedication, Chest Pain, Heart Rate Increased, Atrial Fibrillation, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tirosint
    Dosage: 100mcg capsule nightly, oral
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2012-06-26
    End date: 2012-06-30

Tirosint
    Dosage: 100mcg capsule nightly, oral
    Administration route: Oral
    Indication: Basedow's Disease
    Start date: 2012-06-26
    End date: 2012-06-30

Tirosint
    Dosage: 100mcg capsule nightly, oral
    Administration route: Oral
    Indication: Radioactive Iodine Therapy
    Start date: 2012-06-26
    End date: 2012-06-30

Other drugs received by patient: Furosemide; Unspecified Vitamins; Xanax; Unspecified EYE Drops; Lyrica



Possible Tirosint side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: female, weighing 50.8 kg (111.7 pounds)

Reactions: Abdominal Discomfort

Drug(s) suspected as cause:
Levoxyl
    Dosage: taking half of a 25mcg tablet a day
    Indication: Hypothyroidism
    Start date: 2012-01-01
    End date: 2012-01-01

Tirosint
    Dosage: 13 ug, 1x/day
    Indication: Hypothyroidism



Possible Tirosint side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-07-10

Patient: 57 year old female

Reactions: Malaise, Chest Pain, Heart Rate Increased, Incorrect Dose Administered, Atrial Fibrillation, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tirosint
    Dosage: 100mcg capsule nightly, oral
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2012-06-26
    End date: 2012-06-30

Tirosint
    Dosage: 100mcg capsule nightly, oral
    Administration route: Oral
    Indication: Basedow's Disease
    Start date: 2012-06-26
    End date: 2012-06-30

Tirosint
    Dosage: 100mcg capsule nightly, oral
    Administration route: Oral
    Indication: Radioactive Iodine Therapy
    Start date: 2012-06-26
    End date: 2012-06-30

Other drugs received by patient: Furosemide; Unspecified EYE Drops; Lyrics (Pregabalin); Xanax; Unspecified Vitamins



Possible Tirosint side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: 77 year old female

Reactions: Autoimmune Disorder, Heart Rate Increased, Knee Arthroplasty, Thyroxine Increased, Candidiasis, Arrhythmia, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tirosint

Other drugs received by patient: Cytomel; Diovan; Cardizem



Possible Tirosint side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-15

Patient: female, weighing 67.6 kg (148.7 pounds)

Reactions: Dysgeusia, Abdominal Discomfort, Abdominal Pain, Abdominal Distension, Thirst

Drug(s) suspected as cause:
Levoxyl
    Dosage: 25 ug, 1x/day
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2011-10-01
    End date: 2011-10-01

Synthroid
    Dosage: 25 ug, unk
    Administration route: Oral
    Indication: Autoimmune Thyroiditis
    Start date: 2011-01-01
    End date: 2011-10-13

Tirosint
    Dosage: 25 ug, unk
    Start date: 2011-11-03



Possible Tirosint side effects in 49 year old female

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

Patient: 49 year old female

Reactions: Dyspnoea, Oedema Peripheral, Dehydration, Heart Rate Increased, Hypotension, Drug Interaction, Blood Thyroid Stimulating Hormone Decreased

Drug(s) suspected as cause:
Tirosint

Tirosint
    Dosage: 112 mcg for 5 days weekly/125 mcg for 2 days weekly, oral
    Administration route: Oral
    Indication: Basedow's Disease

Tirosint
    Dosage: 112 mcg for 5 days weekly/125 mcg for 2 days weekly, oral
    Administration route: Oral
    Indication: Radioactive Iodine Therapy



Possible Tirosint side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-16

Patient: female, weighing 54.0 kg (118.8 pounds)

Reactions: Palpitations, Insomnia, Hypertension, Hyperthyroidism

Drug(s) suspected as cause:
Cytomel
    Dosage: unk
    Indication: Hypothyroidism
    End date: 2012-01-06

Tirosint
    Dosage: 63 ug, alternate day
    Indication: Hypothyroidism
    Start date: 2011-04-01



Possible Tirosint side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-13

Patient: female

Reactions: Abdominal Discomfort, Dysgeusia, Abdominal Pain, Abdominal Distension, Thirst

Drug(s) suspected as cause:
Levoxyl
    Dosage: 25 ug, 1x/day
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2011-10-01
    End date: 2011-10-01

Synthroid
    Dosage: 25 ug, unk
    Indication: Autoimmune Thyroiditis
    Start date: 2011-01-01
    End date: 2011-11-02

Tirosint
    Dosage: 25 ug, unk
    Start date: 2011-11-03



Possible Tirosint side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-05

Patient: female

Reactions: Coeliac Disease, Tremor

Drug(s) suspected as cause:
Synthroid
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2003-01-01

Tirosint
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-02-01
    End date: 2011-02-01



Possible Tirosint side effects in female

Reported by a physician from United States on 2012-01-05

Patient: female, weighing 84.9 kg (186.8 pounds)

Reactions: Flushing, Coeliac Disease, Erythema, Paraesthesia

Drug(s) suspected as cause:
Synthroid
    Indication: Hypothyroidism
    Start date: 2011-02-21

Synthroid
    Start date: 2011-03-01
    End date: 2011-03-03

Synthroid

Tirosint
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2011-02-22
    End date: 2011-02-28

Tirosint
    Start date: 2011-03-03
    End date: 2011-03-07

Other drugs received by patient: Allegra; Crestor



Possible Tirosint side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-05

Patient: female

Reactions: Agitation, Anxiety, Malaise, Palpitations, Blood Thyroid Stimulating Hormone Decreased, Headache, Feeling Abnormal, Paraesthesia

Drug(s) suspected as cause:
Synthroid
    Dosage: half of 88mcg plus half of 100mcg daily
    Indication: Autoimmune Thyroiditis
    Start date: 2011-05-01
    End date: 2011-06-01

Synthroid
    Dosage: 88mcg for 5 days, 100mcg for 2 days/week
    End date: 2011-05-01

Tirosint
    Dosage: 88mcg for 5 days, 100mcg for 2 days/week
    Indication: Autoimmune Thyroiditis
    Start date: 2011-06-07



Possible Tirosint side effects in 70 year old female

Reported by a consumer/non-health professional from United States on 2011-12-21

Patient: 70 year old female, weighing 74.8 kg (164.7 pounds)

Reactions: Hallucination, Visual, Vision Blurred, Dizziness, Asthenia, Derealisation

Drug(s) suspected as cause:
Tirosint



Possible Tirosint side effects in female

Reported by a individual with unspecified qualification from United States on 2011-12-06

Patient: female

Reactions: Back Pain, Glossodynia, Nausea, Eye Irritation, Condition Aggravated, Toxicity To Various Agents, Eye Pain, Burning Sensation, Visual Impairment, Dizziness, Metabolic Disorder, Feeling Abnormal

Drug(s) suspected as cause:
Thyroid TAB
    Dosage: 3 pills, 5gr, 3 times a week; 2 pills, 5gr, twice a week

Tirosint
    Dosage: 13 mcg, once daily, oral
    Administration route: Oral



Possible Tirosint side effects in 48 year old female

Reported by a physician from United States on 2011-10-03

Patient: 48 year old female

Reactions: Ventricular Extrasystoles, Drug Intolerance, Hyperhidrosis, Tremor, Hot Flush, Sleep Disorder, Alopecia, Insomnia, Feeling Abnormal

Drug(s) suspected as cause:
Synthroid
    Dosage: 50mcg daily
    Indication: Hypothyroidism
    Start date: 2009-01-01
    End date: 2011-08-10

Tirosint
    Dosage: one capsule daily, oral
    Administration route: Oral
    Indication: Goitre
    Start date: 2011-08-11
    End date: 2011-08-22

Tirosint
    Dosage: one capsule daily, oral
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2011-08-11
    End date: 2011-08-22

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