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Amiodarone Side Effects

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Common Amiodarone Side Effects


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

Hyperthyroidism (240)
Dyspnoea (228)
Atrial Fibrillation (164)
Hypothyroidism (148)
Pulmonary Fibrosis (136)
Pulmonary Toxicity (129)
Bradycardia (123)
Hypotension (118)
Toxicity To Various Agents (117)
Asthenia (117)
Cardiac Arrest (115)
Torsade De Pointes (111)
Fatigue (106)
Dizziness (104)
Electrocardiogram Qt Prolonged (104)
Interstitial Lung Disease (99)
International Normalised Ratio Increased (97)
Ventricular Tachycardia (93)
Nausea (85)
Pneumonia (84)

➢ 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.

Amiodarone Side Effects Reported to FDA



Amiodarone Side Effect Report#9996433
Thyroid Disorder
This is a report of a 56-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Amiodarone (dosage: NA, start time: NS), combined with:
  • Vit D2
  • Insulin Novolin
  • Lisinopril
  • Mag Ox
  • Prednisone
and developed a serious reaction and side effect(s): Thyroid Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amiodarone treatment in male patients, resulting in Thyroid Disorder side effect.
Amiodarone Side Effect Report#9995648
Pyrexia, Fatigue, Dizziness, Weight Decreased, Haemorrhage, Chills, Lethargy, Dyspnoea, Toxicity To Various Agents
This report suggests a potential Amiodarone Hydrochloride Pyrexia side effect(s) that can have serious consequences. A male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Amiodarone Hydrochloride (dosage: By Mouth) starting
Mar 22, 2013. After starting Amiodarone Hydrochloride the patient began experiencing various side effects, including: Pyrexia, Fatigue, Dizziness, Weight Decreased, Haemorrhage, Chills, Lethargy, Dyspnoea, Toxicity To Various AgentsAdditional drugs used concurrently:
  • Baby Aspirin
Although Amiodarone Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pyrexia, may still occur.
Amiodarone Side Effect Report#9981336
Deep Vein Thrombosis, Infusion Site Extravasation
This Deep Vein Thrombosis problem was reported by a health professional from US. A 43-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: ventricular tachycardia. On
Feb 21, 2014 this consumer started treatment with Amiodarone Hydrochloride Injection (dosage: NA). The following drugs were being taken at the same time:
  • Asa
  • Lipitor
  • Albuterol
  • Captopril
  • Rocefin
  • Saline /00075401/ (Nasal Spray)
  • Lasix
  • Novolog
When using Amiodarone Hydrochloride Injection, the patient experienced the following unwanted symptoms/side effects: Deep Vein Thrombosis, Infusion Site ExtravasationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Deep Vein Thrombosis, may become evident only after a product is in use by the general population.
Amiodarone Side Effect Report#9980869
Respiratory Failure
This Respiratory Failure side effect was reported by a physician from US. A 72-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Amiodarone Hcl (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Amiodarone Hcl the consumer reported adverse symptoms, such as: Respiratory FailureThese side effects may potentially be related to Amiodarone Hcl.
Amiodarone Side Effect Report#9972959
Acute Respiratory Distress Syndrome, Depressed Level Of Consciousness, Lobar Pneumonia, Bronchospasm, Cardiac Failure Acute, Bradycardia, Pulmonary Fibrosis
This is a report of a 87-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Amiodarone Hcl (dosage: 1 Df, Daily, start time: NS), combined with:
  • Lysanxia (Unk)
  • Rabeprazole (Unk)
  • Discotrine (Unk)
  • Kardegic (Unk)
and developed a serious reaction and side effect(s): Acute Respiratory Distress Syndrome, Depressed Level Of Consciousness, Lobar Pneumonia, Bronchospasm, Cardiac Failure Acute, Bradycardia, Pulmonary Fibrosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amiodarone Hcl treatment in female patients, resulting in Acute Respiratory Distress Syndrome side effect. The patient was hospitalized.
Amiodarone Side Effect Report#9971920
Hyperthyroidism, Hyperthyroidism, Vomiting, Oropharyngeal Pain
This report suggests a potential Amiodarone Hyperthyroidism side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from CN was diagnosed with the following symptoms/conditions: atrial fibrillation and used Amiodarone (dosage: NA) starting NS. After starting Amiodarone the patient began experiencing various side effects, including: Hyperthyroidism, Hyperthyroidism, Vomiting, Oropharyngeal PainAdditional drugs used concurrently: NA.The patient was hospitalized. Although Amiodarone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyperthyroidism, may still occur.
Amiodarone Side Effect Report#9969633
Myxoedema Coma, Cardiac Arrest
This Myxoedema Coma problem was reported by a health professional from US. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Amiodarone Hcl (dosage: NA). The following drugs were being taken at the same time:
  • Metoprolol (metoprolol)
  • Simvastatin (simvastatin)
  • Omeprazole (omeprazole)
  • Tamsulosiin (tamsulosin)
When using Amiodarone Hcl, the patient experienced the following unwanted symptoms/side effects: Myxoedema Coma, Cardiac ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myxoedema Coma, may become evident only after a product is in use by the general population.
Amiodarone Side Effect Report#9951066
Sinus Bradycardia
This Sinus Bradycardia side effect was reported by a pharmacist from CN. A 76-year-old female patient (weight:NA) experienced the following symptoms/conditions: arrhythmia,ventricular extrasystoles,prophylaxis.The patient was prescribed Amiodarone Hcl (drug dosage: 200 Mg, 1x/day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Amiodarone Hcl the consumer reported adverse symptoms, such as: Sinus BradycardiaThese side effects may potentially be related to Amiodarone Hcl.
Amiodarone Side Effect Report#9942313
Neurotoxicity
This is a report of a 63-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Amiodarone Hcl (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Neurotoxicity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amiodarone Hcl treatment in male patients, resulting in Neurotoxicity side effect.
Amiodarone Side Effect Report#9940785
Malaise, Nausea
This report suggests a potential Amiodarone Hcl Malaise side effect(s) that can have serious consequences. A 82-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: atrial fibrillation and used Amiodarone Hcl (dosage: Unk) starting 201311. After starting Amiodarone Hcl the patient began experiencing various side effects, including: Malaise, NauseaAdditional drugs used concurrently:
  • Eliquis (Daily Or Twice A Day)
Although Amiodarone Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malaise, may still occur.
Amiodarone Side Effect Report#9929938
Acquired Hydrocele, Epididymitis, Scrotal Pain, Scrotal Oedema
This Acquired Hydrocele problem was reported by a health professional from TR. A 53-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Amiodarone (dosage: 100 Mg, Qd). The following drugs were being taken at the same time:
  • Verapamil (240 Mg, Qd)
  • Irbesartan (150 Mg, Qd)
  • Acetylsalicylic Acid
  • Levothyroxine (50 Ug, Unk)
When using Amiodarone, the patient experienced the following unwanted symptoms/side effects: Acquired Hydrocele, Epididymitis, Scrotal Pain, Scrotal OedemaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Acquired Hydrocele, may become evident only after a product is in use by the general population.
Amiodarone Side Effect Report#9929007
Gastric Haemorrhage, Gastritis Erosive, Intracardiac Thrombus, International Normalised Ratio Increased, Prothrombin Time Prolonged, Activated Partial Thromboplastin Time Prolonged, Toxicity To Various Agents
This Gastric Haemorrhage side effect was reported by a health professional from US. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: atrial fibrillation.The patient was prescribed Amiodarone Hcl (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Dabigatran
  • Warfarin
.After starting to take Amiodarone Hcl the consumer reported adverse symptoms, such as: Gastric Haemorrhage, Gastritis Erosive, Intracardiac Thrombus, International Normalised Ratio Increased, Prothrombin Time Prolonged, Activated Partial Thromboplastin Time Prolonged, Toxicity To Various AgentsThese side effects may potentially be related to Amiodarone Hcl. The patient was hospitalized.
Amiodarone Side Effect Report#9927983
Dyspnoea, Pyrexia, Respiratory Failure, Interstitial Lung Disease, Obliterative Bronchiolitis, Pulmonary Toxicity
This is a report of a 70-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Amiodarone (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dyspnoea, Pyrexia, Respiratory Failure, Interstitial Lung Disease, Obliterative Bronchiolitis, Pulmonary Toxicity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amiodarone treatment in female patients, resulting in Dyspnoea side effect. The patient was hospitalized.
Amiodarone Side Effect Report#9927866
Urinary Tract Infection, Unevaluable Event
This report suggests a potential Amiodarone Urinary Tract Infection side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Amiodarone (dosage: Hospital/pres. ?three Times Daily?into A Vein) starting NS. After starting Amiodarone the patient began experiencing various side effects, including: Urinary Tract Infection, Unevaluable EventAdditional drugs used concurrently: NA.The patient was hospitalized. Although Amiodarone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Urinary Tract Infection, may still occur.
Amiodarone Side Effect Report#9925388
Pneumonitis, Pulmonary Alveolar Haemorrhage, Haemoptysis
This Pneumonitis problem was reported by a pharmacist from US. A 82-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On
Feb 04, 2014 this consumer started treatment with Amiodarone (dosage: NA). The following drugs were being taken at the same time:
  • Xarelto
  • Lipitor
  • Hydralazine
  • Metoprolol
  • Tribenzor
  • Flomax
When using Amiodarone, the patient experienced the following unwanted symptoms/side effects: Pneumonitis, Pulmonary Alveolar Haemorrhage, HaemoptysisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pneumonitis, may become evident only after a product is in use by the general population.
Amiodarone Side Effect Report#9925226
Cardiac Failure, Condition Aggravated, Melaena, Toxicity To Various Agents, Gastritis Erosive, Atrial Thrombosis, Activated Partial Thromboplastin Time Prolonged, International Normalised Ratio Increased
This Cardiac Failure side effect was reported by a consumer or non-health professional from US. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: atrial fibrillation.The patient was prescribed Amiodarone (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Dabigatran
.After starting to take Amiodarone the consumer reported adverse symptoms, such as: Cardiac Failure, Condition Aggravated, Melaena, Toxicity To Various Agents, Gastritis Erosive, Atrial Thrombosis, Activated Partial Thromboplastin Time Prolonged, International Normalised Ratio IncreasedThese side effects may potentially be related to Amiodarone. The patient was hospitalized.
Amiodarone Side Effect Report#9924811
Myxoedema Coma, Cardiac Arrest, Ascites
This is a report of a 78-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Amiodarone (amiodarone) (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Myxoedema Coma, Cardiac Arrest, Ascites after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amiodarone (amiodarone) treatment in male patients, resulting in Myxoedema Coma side effect. The patient was hospitalized.
Amiodarone Side Effect Report#9921355
Myxoedema Coma
This report suggests a potential Amiodarone Myxoedema Coma side effect(s) that can have serious consequences. A 78-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: atrial fibrillation and used Amiodarone (dosage: NA) starting NS. After starting Amiodarone the patient began experiencing various side effects, including: Myxoedema ComaAdditional drugs used concurrently:
  • Metoprolol
  • Simvastatin
  • Omeprazole
  • Tamsulosin
The patient was hospitalized. Although Amiodarone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myxoedema Coma, may still occur.
Amiodarone Side Effect Report#9919842
Myxoedema Coma, Cardiac Arrest
This Myxoedema Coma problem was reported by a health professional from US. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Amiodarone (dosage: NA). The following drugs were being taken at the same time:
  • Metoprolol
  • Simvastatin
  • Omeprazole
  • Tamsulosin
When using Amiodarone, the patient experienced the following unwanted symptoms/side effects: Myxoedema Coma, Cardiac ArrestThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myxoedema Coma, may become evident only after a product is in use by the general population.
Amiodarone Side Effect Report#9918193
Rectal Haemorrhage
This Rectal Haemorrhage side effect was reported by a physician from IT. A 88-year-old female patient (weight:NA) experienced the following symptoms/conditions: supraventricular tachycardia.The patient was prescribed Amiodarone Hydrochloride (drug dosage: 200 Mg Daily), which was initiated on
Jan 13, 2014. Concurrently used drugs:
  • Pradaxa (220 Mg Daily)
.After starting to take Amiodarone Hydrochloride the consumer reported adverse symptoms, such as: Rectal HaemorrhageThese side effects may potentially be related to Amiodarone Hydrochloride.
Amiodarone Side Effect Report#9918080
Rectal Haemorrhage
This is a report of a 88-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: supraventricular tachycardia, who was treated with Amiodarone Hydrochloride (dosage: NA, start time:
Jan 13, 2014), combined with:
  • Pradaxa - 110 Mg Capsula Rigida
and developed a serious reaction and side effect(s): Rectal Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amiodarone Hydrochloride treatment in female patients, resulting in Rectal Haemorrhage side effect.
Amiodarone Side Effect Report#9916438
Angina Pectoris, Dyspnoea, Orthopnoea, Atrial Fibrillation, Nodal Rhythm, Extrasystoles, Extrasystoles, Ventricular Tachycardia, Torsade De Pointes
This report suggests a potential Amiodarone Angina Pectoris side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: ventricular tachycardia and used Amiodarone (dosage: NA) starting 2010. After starting Amiodarone the patient began experiencing various side effects, including: Angina Pectoris, Dyspnoea, Orthopnoea, Atrial Fibrillation, Nodal Rhythm, Extrasystoles, Extrasystoles, Ventricular Tachycardia, Torsade De PointesAdditional drugs used concurrently:
  • Ranolazine
  • Aspirin
  • Topiramate
  • Simvastatin
  • Furosemide
  • Omeprazole
  • Acenocoumarol
  • Nitroglycerin
The patient was hospitalized. Although Amiodarone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Angina Pectoris, may still occur.
Amiodarone Side Effect Report#9913703
International Normalised Ratio Increased
This International Normalised Ratio Increased problem was reported by a pharmacist from IT. A 84-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation,respiratory tract infection,cerebrovascular accident prophylaxis. On
Jan 01, 1998 this consumer started treatment with Amiodarone Hydrochloride (dosage: 200 Milligram Daily; 200 Mg Daily). The following drugs were being taken at the same time:
  • Ceftriaxone Disodium (1 Gram Daily; 1 G Daily)
  • Coumadin - 5 Mg Compresse - Bristol Myers Squibb S.r.l. (16.25 Mg Weekly)
  • Lanoxin - 0,125 Mg Compresse
  • Luvion - 50 Mg Compresse
  • Omeprazole Sodium (20 Mg)
  • Ramipril (5 Mg)
  • Bisoprolol Hemifumarate (2.5 Mg)
  • Furosemide (25 Mg)
When using Amiodarone Hydrochloride, the patient experienced the following unwanted symptoms/side effects: International Normalised Ratio IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as International Normalised Ratio Increased, may become evident only after a product is in use by the general population.
Amiodarone Side Effect Report#9913312
Myxoedema Coma, Cardiac Arrest, Hyporeflexia
This Myxoedema Coma side effect was reported by a health professional from US. A 78-year-old male patient (weight:NA) experienced the following symptoms/conditions: atrial fibrillation.The patient was prescribed Amiodarone (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Metoprolol
  • Simvastatin
  • Omeprazole
  • Tamsulosin
.After starting to take Amiodarone the consumer reported adverse symptoms, such as: Myxoedema Coma, Cardiac Arrest, HyporeflexiaThese side effects may potentially be related to Amiodarone. The patient was hospitalized.
Amiodarone Side Effect Report#9913151
Liver Function Test Abnormal
This is a report of a 28-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial flutter, who was treated with Amiodarone (dosage: X1 Than Infusionx24h, start time:
Feb 09, 2014), combined with:
  • Adenosine
  • Lidocaine
  • Carvedilol
  • Lisinopril
and developed a serious reaction and side effect(s): Liver Function Test Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amiodarone treatment in male patients, resulting in Liver Function Test Abnormal side effect. The patient was hospitalized.


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The appearance of Amiodarone 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 Amiodarone Side Effects for Women?

Women Side EffectsReports
Dyspnoea 78
Torsade De Pointes 67
Electrocardiogram Qt Prolonged 66
Hyperthyroidism 66
Hypothyroidism 58
Asthenia 55
Atrial Fibrillation 51
Bradycardia 43
Cardiac Arrest 40
Fatigue 38

What are common Amiodarone Side Effects for Men?

Men Side EffectsReports
Hyperthyroidism 164
Dyspnoea 145
Atrial Fibrillation 111
Pulmonary Fibrosis 105
Pulmonary Toxicity 92
Hypothyroidism 86
Hypotension 84
Toxicity To Various Agents 82
Bradycardia 78
Cardiac Arrest 74

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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.

    Amiodarone 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.

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    How Effective is Amiodarone for You?

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    Amiodarone Safety Alerts, Active Ingredients, Usage Information

    NDC0093-9133
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameAmiodarone Hydrochloride
    NameAmiodarone Hydrochloride
    Dosage FormTABLET
    RouteORAL
    On market since19981130
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)AMIODARONE HYDROCHLORIDE
    Strength(s)200
    Unit(s)mg/1
    Pharma ClassAntiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome

    More About Amiodarone

    Side Effects reported to FDA: 3260

    Amiodarone safety alerts: 2008 2005 2001

    Reported deaths: 409

    Reported hospitalizations: 997

    Simvastatin Used With Amiodarone

    Audience: Cardiologic healthcare professionals, pharmacists, other healthcare professionals

    [Posted 08/08/2008] FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.

    [August 08, 2008 - Drug Information Page - FDA]
    [August 08, 2008 - Information for Healthcare Professionals - FDA]

    [Labels - Simvastatin - DailyMed]
    [Labels - Amiodarone - DailyMed]

    Latest Amiodarone clinical trials