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Simvastatin Side Effects

Common Simvastatin Side Effects

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

Rhabdomyolysis (1122)
Myalgia (992)
Renal Failure Acute (459)
Blood Creatine Phosphokinase Increased (458)
Fatigue (445)
Pain In Extremity (403)
Muscular Weakness (399)
Asthenia (367)
Arthralgia (352)
Muscle Spasms (301)
Pain (282)
Dyspnoea (268)
Dizziness (261)
Nausea (236)
Diarrhoea (221)
Fall (217)
Alanine Aminotransferase Increased (217)
Gait Disturbance (195)
Headache (194)
Myositis (193)

➢ 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.

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.

Simvastatin Side Effects Reported to FDA

The following Simvastatin 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.


The appearance of Simvastatin 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.
Pain In Extremity, Back Pain, Asthenia, Fatigue, Inflammation, Hypoaesthesia
on Mar 12, 2014 Female from GB , 54 years of age, weighting 180.0 lb, was diagnosed with and was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: pain in extremity, back pain, asthenia, fatigue, inflammation, hypoaesthesia. Simvastatin dosage: 40mg. Dose Increased In 2008.
Associated medications used:
  • Starflower Oil
Patient was hospitalized and became disabled.

Completed Suicide
Patient was taking Simvastatin. Patient felt the following Simvastatin side effects: completed suicide on Feb 24, 2014 from US Additional patient health information: Male , 34 years of age, . Simvastatin dosage: N/A.
Multiple prescriptions taken:
  • Carvedilol
Patient was hospitalized.

Sexual Dysfunction, Decreased Appetite, Fatigue, Insomnia, Myalgia
Adverse event was reported on Mar 19, 2014 by a Male taking Simvastatin (Dosage: 20 Mg, 1 /1 Day) was diagnosed with and. Location: GB , 76 years of age, weighting 220.0 lb, After Simvastatin was administered, patient encountered several Simvastatin side effects: sexual dysfunction, decreased appetite, fatigue, insomnia, myalgia.
Multiple concurrent drugs taken:
  • Aspirin
  • Ramipril


Parkinson^s Disease, Blood Pressure Increased
on Mar 11, 2014 Male from BR , weighting 185.2 lb, was diagnosed with and was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: parkinson^s disease, blood pressure increased. Simvastatin dosage: 1 Df, Qd Once In The Morning (20 Mg).
Associated medications used:
  • Clopidogrel (1 Df, Qd Once During Lunch)
  • Clopidogrel
  • Procoralan (Unk Ukn, Unk)
  • Vastarel (Unk Ukn, Unk)
  • Monocordil (Unk Ukn, Unk)
  • Monocordil
  • Omeprazole (Unk Ukn, Unk)
  • Prolopa (Unk Ukn, Unk)



Myalgia, Muscular Weakness
on Mar 11, 2014 Male from SE , 49 years of age, was treated with Simvastatin Arrow. Patient felt the following Simvastatin side effects: myalgia, muscular weakness. Simvastatin Arrow dosage: Unk.

Muscle Spasms
Patient was taking Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: muscle spasms on Mar 07, 2014 from US Additional patient health information: Female , 62 years of age, weighting 180.0 lb, was diagnosed with and. Simvastatin dosage: By Mouth.
Multiple concurrent drugs taken:
  • Inhaler
  • Alkaseler Cold Medicine
  • Zoloft


Hepatitis, Myalgia, Weight Decreased, Lethargy, Asthenia
Adverse event was reported on Mar 06, 2014 by a Male taking Simvastatin (Dosage: N/A) was diagnosed with and. Location: GB , 82 years of age, weighting 163.1 lb, Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: hepatitis, myalgia, weight decreased, lethargy, asthenia.
Associated medications used:
  • Allopurinol (allopurinol)
  • Aspirin (acetylsalicylic Acid)
  • Perindopril (perindopril)


Back Pain, Inflammation, Pain In Extremity, Hypoaesthesia, Fatigue, Asthenia
on Mar 11, 2014 Female from GB , 54 years of age, weighting 180.0 lb, was diagnosed with and was treated with Simvastatin. Patient felt the following Simvastatin side effects: back pain, inflammation, pain in extremity, hypoaesthesia, fatigue, asthenia. Simvastatin dosage: Unk.
Multiple prescriptions taken:
  • Borage Oil
Patient was hospitalized and became disabled.

Myalgia, Asthenia, Muscle Spasms, Pain, Abnormal Dreams
on Mar 10, 2014 Male from SE , 69 years of age, weighting 156.5 lb, was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: myalgia, asthenia, muscle spasms, pain, abnormal dreams. Simvastatin dosage: Unk.

Aspartate Aminotransferase Increased
Patient was taking Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: aspartate aminotransferase increased on Mar 07, 2014 from US Additional patient health information: Female , 55 years of age, weighting 171.1 lb, was diagnosed with and. Simvastatin dosage: N/A.
Associated medications used:
  • Citalopram
  • Clozapine
  • Co
  • Ferrous Sulfate
  • Lorazepam
  • Metoprolol
  • Oxybutynin
  • Miralax


Liver Function Test Abnormal, Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
Adverse event was reported on Mar 07, 2014 by a Female taking Simvastatin (Dosage: Simvastatin 40mg Tablet Po 8:30) was diagnosed with and. Location: US , 35 years of age, weighting 124.0 lb, Patient felt the following Simvastatin side effects: liver function test abnormal, blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased.
Multiple prescriptions taken:
  • Acetaminophen
  • Benzotropine
  • Duloxetine
  • Omeprazole
Patient was hospitalized.

Lethargy, Weight Decreased, Hepatitis, Myalgia, Asthenia
on Mar 10, 2014 Male from GB , 82 years of age, weighting 163.1 lb, was diagnosed with and was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: lethargy, weight decreased, hepatitis, myalgia, asthenia. Simvastatin dosage: N/A.
Multiple concurrent drugs taken:
  • Allopurinol
  • Aspirin
  • Perindopril


Head Injury, Fall, Victim Of Spousal Abuse, Contusion, Psoriasis, Rash, Dizziness, Amnesia
on Mar 07, 2014 Female from AU , 79 years of age, was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: head injury, fall, victim of spousal abuse, contusion, psoriasis, rash, dizziness, amnesia. Simvastatin dosage: Unk.
Associated medications used:
  • Cartia /00002701/ (Unk)
  • Tenormin (Unk)
  • Tritace (Unk)
  • Thyroxine (Unk)
  • Atacand (Unk)


Dementia, Fear, Product Substitution Issue, Memory Impairment
Patient was taking Simvastatin 40 Mg. Patient felt the following Simvastatin side effects: dementia, fear, product substitution issue, memory impairment on Mar 06, 2014 from US Additional patient health information: Female , 73 years of age, weighting 175.0 lb, was diagnosed with and. Simvastatin 40 Mg dosage: N/A.

Myalgia, Nasopharyngitis, Dizziness, Constipation, Dyspepsia, Headache, Pain
Adverse event was reported on Mar 05, 2014 by a Male taking Simvastatin (Dosage: N/A) was diagnosed with and. Location: GB , 75 years of age, weighting 224.0 lb, After Simvastatin was administered, patient encountered several Simvastatin side effects: myalgia, nasopharyngitis, dizziness, constipation, dyspepsia, headache, pain.
Multiple concurrent drugs taken:
  • Warfarin
Patient was hospitalized.

Abdominal Distension
on Mar 05, 2014 Male from GB , 67 years of age, weighting 207.0 lb, was treated with Simvastatin (simvastatin). Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: abdominal distension. Simvastatin (simvastatin) dosage: N/A.
Associated medications used:
  • Atorvastatin
  • Levothyroxine


Hepatitis, Myalgia, Lethargy, Asthenia, Weight Decreased
on Mar 07, 2014 Male from GB , 82 years of age, weighting 163.1 lb, was diagnosed with and was treated with Simvastatin. Patient felt the following Simvastatin side effects: hepatitis, myalgia, lethargy, asthenia, weight decreased. Simvastatin dosage: Unk.
Multiple prescriptions taken:
  • Allopurinol
  • Aspirin
  • Perindopril


Abdominal Distension
Patient was taking Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: abdominal distension on Mar 06, 2014 from GB Additional patient health information: Male , 67 years of age, weighting 207.0 lb, . Simvastatin dosage: N/A.
Multiple concurrent drugs taken:
  • Atorvastatin
  • Levothyroxine


Blood Glucose Increased, Muscle Spasms, Myopathy, Neuropathy Peripheral, Sleep Disorder
Adverse event was reported on Mar 06, 2014 by a Male taking Simvastatin (Dosage: N/A) . Location: GB , 48 years of age, weighting 123.5 lb, Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: blood glucose increased, muscle spasms, myopathy, neuropathy peripheral, sleep disorder.
Associated medications used:
  • Atorvastatin Calcium
  • Pravastatin Sodium
  • Aspirin
  • Lantus
  • Novorapid


Muscle Rupture, Fall, Atrial Fibrillation
on Mar 06, 2014 Male from FR , 63 years of age, was treated with Simvastatin. Patient felt the following Simvastatin side effects: muscle rupture, fall, atrial fibrillation. Simvastatin dosage: 20 Mg, Daily.
Multiple prescriptions taken:
  • Cordarone (200 Mg, (per Day, 5 Days Per Week))
  • Cordarone (200 Mg, Daily)
  • Xarelto (20 Mg, Daily)
  • Nisisco (1 Df, Daily)
  • Mediatensyl (120 Mg, Daily)
  • Hemigoxine Nativelle (0.125 Mg, Daily)
  • Stagid (2100 Mg, Daily)
  • Januvia (1 Df, Daily)


Hypersensitivity, Arthritis, Muscle Spasms, Tenderness, Arthralgia, Gait Disturbance, Paraesthesia, Fear
on Mar 05, 2014 Female from US , 59 years of age, weighting 155.0 lb, was diagnosed with and was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: hypersensitivity, arthritis, muscle spasms, tenderness, arthralgia, gait disturbance, paraesthesia, fear. Simvastatin dosage: Taken By Mouth.

Muscle Spasms, Pain, Toxicity To Various Agents
Patient was taking Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: muscle spasms, pain, toxicity to various agents on Mar 05, 2014 from US Additional patient health information: Male , 57 years of age, weighting 218.0 lb, was diagnosed with and. Simvastatin dosage: 1 Pill Once Daily Taken By Mouth.

Abdominal Distension
Adverse event was reported on Mar 06, 2014 by a Male taking Simvastatin (Dosage: N/A) . Location: GB , 67 years of age, weighting 207.0 lb, Patient felt the following Simvastatin side effects: abdominal distension.
Multiple prescriptions taken:
  • Atorvastatin
  • Levothyroxine


Myalgia, Lethargy, Asthenia, Weight Decreased, Hepatitis
on Mar 06, 2014 Male from GB , 82 years of age, weighting 163.1 lb, was diagnosed with and was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: myalgia, lethargy, asthenia, weight decreased, hepatitis. Simvastatin dosage: N/A.
Multiple concurrent drugs taken:
  • Aspirin
  • Allopurinol
  • Perindopril/perindopril Erbumine


Nasopharyngitis, Myalgia, Headache, Constipation, Dyspepsia, Dizziness
on Mar 06, 2014 Male from GB , 75 years of age, weighting 224.0 lb, was diagnosed with and was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: nasopharyngitis, myalgia, headache, constipation, dyspepsia, dizziness. Simvastatin dosage: N/A.
Associated medications used:
  • Warfarin
Patient was hospitalized.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Simvastatin Side Effects

    Did You Have a Simvastatin Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Simvastatin for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative SIMVASTATIN Names:SIMVASTAT

    Active Ingredient: SIMVASTAT

    Simvastatin Dosage, Warnings, Usage.

    Side Effects reported to FDA: 8348

    Simvastatin safety alerts: 2011 2010 2008

    Reported deaths: 559

    Reported hospitalizations: 3020

    Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations

    Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor


     

    [UPDATED 12/15/2011] FDA notified the public that it has revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction.

     

    [Posted 06/08/2011]

    AUDIENCE: Family Practice, Cardiology, Pharmacy

    ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.

    BACKGROUND: The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).

    RECOMMENDATION: Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.  


    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

     

    [12/15/2011 - Drug Safety Communication - FDA
    [06/08/2011 - Drug Safety Communication - FDA]
    [06/08/2011 - News Release - FDA]
    [06/08/2011 - Consumer Update - FDA

    Previous MedWatch Alert

    [03/19/2010]

    Latest Simvastatin clinical trials