PatientsVille.com Logo

Thyroid Side Effects

PatientsVille

Common Thyroid Side Effects


The most commonly reported Thyroid side effects (click to view or check a box to report):

Fatigue (47)
Hypothyroidism (38)
Alopecia (37)
Product Formulation Issue (23)
Headache (23)
Palpitations (22)
Dizziness (21)
Diarrhoea (21)
Dyspnoea (21)
Feeling Abnormal (21)
Product Substitution Issue (20)
Chest Pain (20)
Pain (20)
Asthenia (19)
Weight Increased (19)
Product Quality Issue (18)
Blood Thyroid Stimulating Hormone Increased (17)
Depression (17)
Heart Rate Increased (17)
Insomnia (17)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Thyroid Side Effects Reported to FDA



Thyroid Side Effect Report#8937102
Muscular Weakness, Myalgia, Paralysis, Viral Infection, Myopathy Endocrine
This is a report of a 41-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: hypothyroidism, who was treated with Thyroid, Porcine (dosage: 1 Pill Daily Po, start time:
Jun 01, 2009), combined with: NA. and developed a serious reaction and side effect(s): Muscular Weakness, Myalgia, Paralysis, Viral Infection, Myopathy Endocrine after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Thyroid, Porcine treatment in female patients, resulting in Muscular Weakness side effect. The patient was hospitalized.
Thyroid Side Effect Report#8896444
Dermatitis Herpetiformis, Blister
This report suggests a potential Thyroid Dermatitis Herpetiformis side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Thyroid (dosage: 1 Tablet Daily Po) starting
Sep 02, 2012. After starting Thyroid the patient began experiencing various side effects, including: Dermatitis Herpetiformis, BlisterAdditional drugs used concurrently: NA. Although Thyroid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dermatitis Herpetiformis, may still occur.
Thyroid Side Effect Report#8879058
No Adverse Event
This No Adverse Event problem was reported by a health professional from US. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypothyroidism. On NS this consumer started treatment with Thyroid (dosage: NA). The following drugs were being taken at the same time: NA. When using Thyroid, the patient experienced the following unwanted symptoms/side effects: No Adverse EventAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as No Adverse Event, may become evident only after a product is in use by the general population.
Thyroid Side Effect Report#8494069-5
Hallucination, Psychotic Disorder
This Hallucination side effect was reported by a physician from United States. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Thyroid Tab (drug dosage: NA), which was initiated on
Apr 01, 2012. Concurrently used drugs:
  • Carbamazepine
  • Tamsulosin Hcl
  • Ampyra (10 Mg, Bid, Oral)
  • Sertraline Hydrochloride
.After starting to take Thyroid Tab the consumer reported adverse symptoms, such as: Hallucination, Psychotic DisorderThese side effects may potentially be related to Thyroid Tab.
Thyroid Side Effect Report#8470536-5
Deep Vein Thrombosis
This is a report of a 75-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Thyroid Tab (dosage: NA, start time:
Sep 01, 2011), combined with:
  • Acyclovir
  • Calcium Carbonate
  • Fish Oil (fish Oil)
  • Hydrocodone Bitartrate
  • Aspirin
  • Miralax
  • Revlimid (5 Mg, 1 In 1 D, Po)
and developed a serious reaction and side effect(s): Deep Vein Thrombosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Thyroid Tab treatment in female patients, resulting in Deep Vein Thrombosis side effect.
Thyroid Side Effect Report#8429805-7
Constipation, Fatigue, Alopecia, Blood Thyroid Stimulating Hormone Increased
This report suggests a potential Thyroid Tab Constipation side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: hypothyroidism,migraine and used Thyroid Tab (dosage: 60-90 Mg Daily) starting
Feb 16, 2011. After starting Thyroid Tab the patient began experiencing various side effects, including: Constipation, Fatigue, Alopecia, Blood Thyroid Stimulating Hormone IncreasedAdditional drugs used concurrently:
  • Imitrex (As Needed)
  • M.v.i.
  • Albuterol (As Needed)
  • Fish Oil
  • Calcium
  • Losartan
Although Thyroid Tab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Constipation, may still occur.
Thyroid Side Effect Report#8428719-6
Limb Asymmetry, Atypical Femur Fracture, Fracture Displacement, Groin Pain, Stress Fracture, Intervertebral Disc Protrusion, Pulmonary Embolism, Fall, Deep Vein Thrombosis
This Limb Asymmetry problem was reported by a health professional from United States. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Thyroid Tab (dosage: NA). The following drugs were being taken at the same time:
  • Actonel
  • Aspirin
  • Verapamil
  • Vitamin D
  • Vitamin E
When using Thyroid Tab, the patient experienced the following unwanted symptoms/side effects: Limb Asymmetry, Atypical Femur Fracture, Fracture Displacement, Groin Pain, Stress Fracture, Intervertebral Disc Protrusion, Pulmonary Embolism, Fall, Deep Vein ThrombosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Limb Asymmetry, may become evident only after a product is in use by the general population.
Thyroid Side Effect Report#8427925-4
Off Label Use, Bronchitis, Cough
This Off Label Use side effect was reported by a consumer or non-health professional from United States. A 83-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Thyroid Pill (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Acid Reflux Pill
  • Paxil
  • Atenolol
  • Symbicort (80/4.5 Mcg, 2 Puffs, Two Times A Day)
  • Vitamin Tab
.After starting to take Thyroid Pill the consumer reported adverse symptoms, such as: Off Label Use, Bronchitis, CoughThese side effects may potentially be related to Thyroid Pill.
Thyroid Side Effect Report#8424277-0
Malaise, Dyspnoea, Off Label Use
This is a report of a 72-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Thyroid Pill (dosage: NA, start time:
Jan 01, 2005), combined with:
  • Xotnex Haf
  • Pulmicort Flexhaler (180 Mcg Two Puffs Two Times A Day)
  • Lipitor
  • Pulmicort Flexhaler (180 Mcg One Puff Daily)
and developed a serious reaction and side effect(s): Malaise, Dyspnoea, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Thyroid Pill treatment in female patients, resulting in Malaise side effect.
Thyroid Side Effect Report#8417982-3
Hypoxia, Breast Cancer In Situ, Fibrosis, Fatigue, Exercise Tolerance Decreased, Atrial Septal Defect
This report suggests a potential Thyroid Tab Hypoxia side effect(s) that can have serious consequences. A 42-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Thyroid Tab (dosage: NA) starting NS. After starting Thyroid Tab the patient began experiencing various side effects, including: Hypoxia, Breast Cancer In Situ, Fibrosis, Fatigue, Exercise Tolerance Decreased, Atrial Septal DefectAdditional drugs used concurrently:
  • Mustargen
  • Lexapro (escitalopram Ocalate)
  • Calcium/vitamin D (lekovit Ca)
  • Levothyroxine Sodium
Although Thyroid Tab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypoxia, may still occur.
Thyroid Side Effect Report#8414028-8
Heart Rate Increased, Feeling Abnormal, Thinking Abnormal, Alopecia, Dry Skin, Contusion, Condition Aggravated, Blood Thyroid Stimulating Hormone Increased, Heart Rate Irregular
This Heart Rate Increased problem was reported by a health professional from United States. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 01, 2011 this consumer started treatment with Thyroid Tab (dosage: 90 Mg, Unk). The following drugs were being taken at the same time: NA. When using Thyroid Tab, the patient experienced the following unwanted symptoms/side effects: Heart Rate Increased, Feeling Abnormal, Thinking Abnormal, Alopecia, Dry Skin, Contusion, Condition Aggravated, Blood Thyroid Stimulating Hormone Increased, Heart Rate IrregularAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Heart Rate Increased, may become evident only after a product is in use by the general population.
Thyroid Side Effect Report#8397077-8
Blood Pressure Increased, Insomnia, Palpitations, Thyroid Function Test Abnormal, Hyperhidrosis, Hot Flush
This Blood Pressure Increased side effect was reported by a consumer or non-health professional from United States. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Thyroid Tab (drug dosage: 60 Mg), which was initiated on
Jan 01, 2009. Concurrently used drugs:
  • Simvastatin
.After starting to take Thyroid Tab the consumer reported adverse symptoms, such as: Blood Pressure Increased, Insomnia, Palpitations, Thyroid Function Test Abnormal, Hyperhidrosis, Hot FlushThese side effects may potentially be related to Thyroid Tab.
Thyroid Side Effect Report#8390782-9
Visual Impairment, Malaise, Eyelid Ptosis, Headache, Pain, Abdominal Discomfort, Diarrhoea, Diplopia
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: hypothyroidism,anxiety,panic attack, who was treated with Thyroid Tab (dosage: Unk, start time:
Oct 01, 2010), combined with:
  • Alprazolam (0.5 Mg, As Needed)
  • Alprazolam
and developed a serious reaction and side effect(s): Visual Impairment, Malaise, Eyelid Ptosis, Headache, Pain, Abdominal Discomfort, Diarrhoea, Diplopia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Thyroid Tab treatment in female patients, resulting in Visual Impairment side effect.
Thyroid Side Effect Report#8389567-9
Abdominal Discomfort, Diarrhoea
This report suggests a potential Thyroid Abdominal Discomfort side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Thyroid (dosage: NA) starting
May 13, 2012. After starting Thyroid the patient began experiencing various side effects, including: Abdominal Discomfort, DiarrhoeaAdditional drugs used concurrently:
  • Vitamins Nos
  • Naproxen Sodium (Prn)
Although Thyroid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Discomfort, may still occur.
Thyroid Side Effect Report#8374824-2
Thyroid Neoplasm, Dysphagia, Blood Thyroid Stimulating Hormone Increased
This Thyroid Neoplasm problem was reported by a consumer or non-health professional from United States. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 02, 2012 this consumer started treatment with Thyroid Tab (dosage: 15 Mg). The following drugs were being taken at the same time: NA. When using Thyroid Tab, the patient experienced the following unwanted symptoms/side effects: Thyroid Neoplasm, Dysphagia, Blood Thyroid Stimulating Hormone IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thyroid Neoplasm, may become evident only after a product is in use by the general population.
Thyroid Side Effect Report#8367370-3
Gallbladder Disorder, Autoimmune Thyroiditis, Weight Decreased, Depression, Back Disorder, Decreased Appetite, Blood Cholesterol Increased, Joint Range Of Motion Decreased, Alopecia
This Gallbladder Disorder side effect was reported by a consumer or non-health professional from United States. A female patient (weight:NA) experienced the following symptoms/conditions: thyroid disorder.The patient was prescribed Thyroid Tab (drug dosage: Unk), which was initiated on
May 03, 2012. Concurrently used drugs:
  • Effexor (Unk)
  • Zyprexa (5 Mg, Daily)
  • Effexor (75 Mg, Daily)
  • Pristiq (Unk)
  • Prozac (10 Mg, Daily)
  • Effexor (50 Mg, Daily)
  • Clonazepam (0.5 Mg One In Morning And Two At Night, 2x/day)
  • Cozaar (50 Mg, Daily)
.After starting to take Thyroid Tab the consumer reported adverse symptoms, such as: Gallbladder Disorder, Autoimmune Thyroiditis, Weight Decreased, Depression, Back Disorder, Decreased Appetite, Blood Cholesterol Increased, Joint Range Of Motion Decreased, AlopeciaThese side effects may potentially be related to Thyroid Tab. The patient was hospitalized.
Thyroid Side Effect Report#8366667-0
White Blood Cell Count Decreased, Platelet Count Decreased
This is a report of a 71-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Thyroid Tab (dosage: NA, start time:
Aug 05, 2011), combined with:
  • Prilosec
  • Cranberry (cranberry Berco)
  • Multivitamin
  • Benicar Hct
  • Femara
  • Neurontin
  • Revlimid (25 Mg, Daily X21 Days, Po ; 25 Mg, Daily X21 Days, Po ; 10 Mg, 1 In 1 D, Po)
  • Revlimid (25 Mg, Daily X21 Days, Po ; 25 Mg, Daily X21 Days, Po ; 10 Mg, 1 In 1 D, Po)
and developed a serious reaction and side effect(s): White Blood Cell Count Decreased, Platelet Count Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Thyroid Tab treatment in female patients, resulting in White Blood Cell Count Decreased side effect.
Thyroid Side Effect Report#8350166-6
Gastrointestinal Disorder, Urticaria, Weight Decreased
This report suggests a potential Thyroid Preparation Gastrointestinal Disorder side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Thyroid Preparation (dosage: NA) starting
Dec 01, 2010. After starting Thyroid Preparation the patient began experiencing various side effects, including: Gastrointestinal Disorder, Urticaria, Weight DecreasedAdditional drugs used concurrently:
  • Cyclobenzaprine
  • Lorazepam
Although Thyroid Preparation demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gastrointestinal Disorder, may still occur.
Thyroid Side Effect Report#8349423-9
Malaise, Heart Rate Increased, Blood Pressure Increased, Dyspnoea
This Malaise problem was reported by a consumer or non-health professional from United States. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypothyroidism,sleep apnoea syndrome. On
Aug 18, 2010 this consumer started treatment with Thyroid Tab (dosage: NA). The following drugs were being taken at the same time:
  • Nuvigil (150 Milligram;)
When using Thyroid Tab, the patient experienced the following unwanted symptoms/side effects: Malaise, Heart Rate Increased, Blood Pressure Increased, DyspnoeaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Malaise, may become evident only after a product is in use by the general population.
Thyroid Side Effect Report#8342163-1
Fatigue, Migraine, Gastric Disorder, Depressed Mood, Autoimmune Thyroiditis, Fibromyalgia, Irritable Bowel Syndrome, Rash, Erythema
This Fatigue side effect was reported by a consumer or non-health professional from United States. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Thyroid (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Excedrin Extra Strength Tablets (2 Df, Prn)
.After starting to take Thyroid the consumer reported adverse symptoms, such as: Fatigue, Migraine, Gastric Disorder, Depressed Mood, Autoimmune Thyroiditis, Fibromyalgia, Irritable Bowel Syndrome, Rash, ErythemaThese side effects may potentially be related to Thyroid.
Thyroid Side Effect Report#8336731-0
Unevaluable Event
This is a report of a male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: thyroid disorder,fatigue,agitation, who was treated with Thyroid Tab (dosage: NA, start time:
Jan 01, 2008), combined with:
  • Nuvigil (125 Milligram;)
  • Alprazolam
and developed a serious reaction and side effect(s): Unevaluable Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Thyroid Tab treatment in male patients, resulting in Unevaluable Event side effect.
Thyroid Side Effect Report#8330024-3
Cerebrovascular Accident, Injury
This report suggests a potential Thyroid Cerebrovascular Accident side effect(s) that can have serious consequences. A 39-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Thyroid (dosage: 2 Grains) starting
Feb 20, 2007. After starting Thyroid the patient began experiencing various side effects, including: Cerebrovascular Accident, InjuryAdditional drugs used concurrently:
  • Metformin Hcl (500 Mg, Qd)
  • Adderall 5 (20 Mg, Unk)
  • Glucophage (500 Mg, Bid)
  • Inderal
  • Yasmin (Unk)
  • Zoloft (1 ? Tablets)
  • Hydrochlorothiazide (12.5 Mg, Qd)
  • Thyroid Tab (120 Mg, Unk)
The patient was hospitalized. Although Thyroid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebrovascular Accident, may still occur.
Thyroid Side Effect Report#8324355-0
Dyspnoea, Fatigue, Headache, Hunger, Burning Sensation
This Dyspnoea problem was reported by a consumer or non-health professional from United States. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
May 13, 2011 this consumer started treatment with Thyroid Tab (dosage: NA). The following drugs were being taken at the same time:
  • Gilenya (0.5 Mg, Daily, Oral)
When using Thyroid Tab, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, Fatigue, Headache, Hunger, Burning SensationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspnoea, may become evident only after a product is in use by the general population.
Thyroid Side Effect Report#8322607-1
Dyspnoea, Palpitations, Hypothyroidism, Feeling Abnormal, Dizziness, Suicidal Ideation
This Dyspnoea side effect was reported by a consumer or non-health professional from United States. A 85-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Thyroid Tab (drug dosage: 30 Mg), which was initiated on
Apr 01, 2012. Concurrently used drugs: NA..After starting to take Thyroid Tab the consumer reported adverse symptoms, such as: Dyspnoea, Palpitations, Hypothyroidism, Feeling Abnormal, Dizziness, Suicidal IdeationThese side effects may potentially be related to Thyroid Tab.
Thyroid Side Effect Report#8319065-X
Cerebrovascular Accident
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: thyroid disorder, who was treated with Thyroid (dosage: Unk 2x/day, start time: NS), combined with:
  • Acetylsalicylic Acid (81 Mg,daily)
  • Preparation H Hemorrhoidal Suppositories (Unk As Needed)
and developed a serious reaction and side effect(s): Cerebrovascular Accident after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Thyroid treatment in female patients, resulting in Cerebrovascular Accident side effect. The patient was hospitalized.


1 of 15 


The appearance of Thyroid on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Thyroid Side Effects for Women?

Women Side EffectsReports
Fatigue 44
Hypothyroidism 37
Alopecia 34
Palpitations 22
Headache 21
Product Formulation Issue 21
Chest Pain 20
Feeling Abnormal 20
Diarrhoea 19
Dizziness 19

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Thyroid reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Thyroid Side Effects

    Did You Have a Thyroid Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Thyroid for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Thyroid Safety Alerts, Active Ingredients, Usage Information

    NDC0456-0457
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameArmour Thyroid THYROID, PORCINE
    NameTABLET
    Dosage FormORAL
    Route19960401
    On market sinceForest Laboratories, Inc
    LabelerTHYROID, PORCINE
    Active Ingredient(s)15
    Strength(s)mg/1
    Unit(s)
    Pharma Class

    More About Thyroid

    Side Effects reported to FDA: 373

    Thyroid safety alerts: 2011

    Reported deaths: 4

    Reported hospitalizations: 72

    Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis

    [Posted 06/13/2011]

    AUDIENCE: Endocrinology, Family Practice

    ISSUE: Novo Nordisk reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy (REMS). The letter is being sent because a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza.

    Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Additionally, in clinical trials studying Victoza, there were more cases of pancreatitis in patients treated with Victoza than in patients treated with comparators.

    BACKGROUND: FDA may require a REMS for newly or already approved prescription drug product when FDA determines that a REMS is necessary to ensure the benefits of a drug outweigh the risks of the drug. Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

    RECOMMENDATION: Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation.

    After initiation of Victoza, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting).

    Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


    [June 2011 - Dear Healthcare Professional Letter - Novo Nordisk]

    [May 2011 - Prescribing Information - Novo Nordisk]

    Latest Thyroid clinical trials