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Rosuvastatin Side Effects

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Common Rosuvastatin Side Effects


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

Myalgia (106)
Rhabdomyolysis (77)
Renal Failure Acute (47)
Blood Creatine Phosphokinase Increased (37)
Dyspnoea (29)
Muscular Weakness (22)
Diarrhoea (20)
Chest Pain (19)
Arthralgia (19)
Renal Failure (18)
Hepatic Enzyme Increased (17)
Pain In Extremity (17)
Dizziness (16)
Nausea (15)
Fatigue (15)
Asthenia (14)
Headache (13)
Malaise (13)
Vomiting (13)
Muscle Spasms (13)

➢ 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.

Rosuvastatin Side Effects Reported to FDA



Rosuvastatin Side Effect Report#9926769
Hepatotoxicity
This is a report of a 75-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Rosuvastatin (dosage: NA, start time: NS), combined with:
  • Clopidogrel
  • Lortab
  • Esomeprazole
  • Levothyroxine
  • Pregabalin
  • Risedronate
and developed a serious reaction and side effect(s): Hepatotoxicity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rosuvastatin treatment in female patients, resulting in Hepatotoxicity side effect. The patient was hospitalized.
Rosuvastatin Side Effect Report#9879737
Renal Failure, Hepatic Failure, Hepatomegaly, Rhabdomyolysis, Asthenia, Myalgia, Muscular Weakness, Dyskinesia
This report suggests a potential Rosuvastatin Renal Failure side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: hyperlipidaemia and used Rosuvastatin (dosage: 10 Mg/day) starting NS. After starting Rosuvastatin the patient began experiencing various side effects, including: Renal Failure, Hepatic Failure, Hepatomegaly, Rhabdomyolysis, Asthenia, Myalgia, Muscular Weakness, DyskinesiaAdditional drugs used concurrently:
  • Warfarin (2.5 Mg/day)
  • Telmisartan (80 Mg/day)
  • Ranitidine (150 Mg/day)
  • Furosemide (26 Mg/day)
  • Carvedilol (6.25 Mg, Bid)
The patient was hospitalized. Although Rosuvastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure, may still occur.
Rosuvastatin Side Effect Report#9857839
Muscle Atrophy, Amnesia
This Muscle Atrophy problem was reported by a consumer or non-health professional from GB. A 60-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypercholesterolaemia. On 201311 this consumer started treatment with Rosuvastatin (dosage: NA). The following drugs were being taken at the same time:
  • Simvastatin
  • Statin Nos
  • Aspirin
  • Co-codamol
  • Deep Heat (Daily)
  • Green-lipped Mussel
  • Ibuprofen
  • Insulin Glargine
When using Rosuvastatin, the patient experienced the following unwanted symptoms/side effects: Muscle Atrophy, AmnesiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Muscle Atrophy, may become evident only after a product is in use by the general population.
Rosuvastatin Side Effect Report#9818871
Fall, Hypophagia, Renal Failure Acute, Rhabdomyolysis, Haemodialysis
This Fall side effect was reported by a pharmacist from US. A 85-year-old female patient (weight:NA) experienced the following symptoms/conditions: hyperlipidaemia.The patient was prescribed Rosuvastatin (drug dosage: NA), which was initiated on
Dec 26, 2013. Concurrently used drugs:
  • Megace
  • Cilostazol
  • Diltiazem
  • Pioglitazone
  • Aggrenox
.After starting to take Rosuvastatin the consumer reported adverse symptoms, such as: Fall, Hypophagia, Renal Failure Acute, Rhabdomyolysis, HaemodialysisThese side effects may potentially be related to Rosuvastatin. The patient was hospitalized and became disabled.
Rosuvastatin Side Effect Report#9791959
Coronary Artery Occlusion, Nasopharyngitis, Dyspnoea, Fatigue
This is a report of a 60-year-old male patient (weight: NA) from BR, suffering from the following health symptoms/conditions: blood cholesterol increased,coronary artery occlusion, who was treated with Rosuvastatin Calcium (dosage: NA, start time: 2006), combined with:
  • Selozok
  • Brilinta
  • Losartan
  • Sustrate
  • Asa Infant
and developed a serious reaction and side effect(s): Coronary Artery Occlusion, Nasopharyngitis, Dyspnoea, Fatigue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rosuvastatin Calcium treatment in male patients, resulting in Coronary Artery Occlusion side effect. The patient was hospitalized.
Rosuvastatin Side Effect Report#9791347
Mouth Ulceration
This report suggests a potential Rosuvastatin Mouth Ulceration side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: hypercholesterolaemia and used Rosuvastatin (dosage: NA) starting
Oct 01, 2013. After starting Rosuvastatin the patient began experiencing various side effects, including: Mouth UlcerationAdditional drugs used concurrently:
  • Fexofenadine
  • Furosemide
  • Levothyroxine
  • Ramipril
  • Venlafaxine Hydrochloride
Although Rosuvastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Mouth Ulceration, may still occur.
Rosuvastatin Side Effect Report#9781344
Renal Failure Acute, Rhabdomyolysis, Renal Tubular Necrosis, Myocardial Infarction, Vomiting, Haematochezia, Haematoma, Anal Fissure
This Renal Failure Acute problem was reported by a physician from NL. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Sep 24, 2013 this consumer started treatment with Rosuvastatine (dosage: NA). The following drugs were being taken at the same time:
  • Ticagrelor
  • Metoprolol
  • Perindopril
  • Omeprazol
  • Ezetrol
When using Rosuvastatine, the patient experienced the following unwanted symptoms/side effects: Renal Failure Acute, Rhabdomyolysis, Renal Tubular Necrosis, Myocardial Infarction, Vomiting, Haematochezia, Haematoma, Anal FissureThe 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 Renal Failure Acute, may become evident only after a product is in use by the general population.
Rosuvastatin Side Effect Report#9734686
Pancreatitis Acute
This Pancreatitis Acute side effect was reported by a consumer or non-health professional from US. A 72-year-old male patient (weight:NA) experienced the following symptoms/conditions: hyperlipidaemia.The patient was prescribed Rosuvastatin (drug dosage: NA), which was initiated on
Oct 16, 2013. Concurrently used drugs: NA..After starting to take Rosuvastatin the consumer reported adverse symptoms, such as: Pancreatitis AcuteThese side effects may potentially be related to Rosuvastatin. The patient was hospitalized.
Rosuvastatin Side Effect Report#9734651
Dyspnoea Exertional, Myalgia
This is a report of a 62-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Rosuvastatin (dosage: NA, start time:
Aug 06, 2013), combined with:
  • Aspirin
  • Bisoprolol
  • Buspirone Hydrochloride
  • Co-codamol
  • Ezetimibe
  • Gaviscon Advance
  • Gliclazide
  • Glyceryl Trinitrate
and developed a serious reaction and side effect(s): Dyspnoea Exertional, Myalgia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rosuvastatin treatment in male patients, resulting in Dyspnoea Exertional side effect.
Rosuvastatin Side Effect Report#9716128
Rhabdomyolysis
This report suggests a potential Rosuvastatin Rhabdomyolysis side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Rosuvastatin (dosage: NA) starting
Jan 04, 2010. After starting Rosuvastatin the patient began experiencing various side effects, including: RhabdomyolysisAdditional drugs used concurrently: NA.The patient was hospitalized. Although Rosuvastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rhabdomyolysis, may still occur.
Rosuvastatin Side Effect Report#9687600
Muscle Spasms, Myalgia
This Muscle Spasms problem was reported by a pharmacist from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: hyperlipidaemia. On
Oct 03, 2011 this consumer started treatment with Rosuvastatin (dosage: NA). The following drugs were being taken at the same time: NA. When using Rosuvastatin, the patient experienced the following unwanted symptoms/side effects: Muscle Spasms, MyalgiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Muscle Spasms, may become evident only after a product is in use by the general population.
Rosuvastatin Side Effect Report#9685197
Renal Disorder, Liver Disorder, Myopathy
This Renal Disorder side effect was reported by a physician from GR. A 53-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Rosuvastatin (drug dosage: NA), which was initiated on 2013. Concurrently used drugs:
  • Ramipril
  • Eplerenone
  • Furosemide
  • Ticagrelor
.After starting to take Rosuvastatin the consumer reported adverse symptoms, such as: Renal Disorder, Liver Disorder, MyopathyThese side effects may potentially be related to Rosuvastatin.
Rosuvastatin Side Effect Report#9677957
Myalgia
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: hyperlipidaemia, who was treated with Rosuvastatin (dosage: NA, start time:
Jul 29, 2011), combined with: NA. and developed a serious reaction and side effect(s): Myalgia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rosuvastatin treatment in male patients, resulting in Myalgia side effect.
Rosuvastatin Side Effect Report#9638365
Myalgia, Gastrooesophageal Reflux Disease, Muscle Spasms
This report suggests a potential Rosuvastatin Myalgia side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hyperlipidaemia and used Rosuvastatin (dosage: NA) starting
Dec 30, 2011. After starting Rosuvastatin the patient began experiencing various side effects, including: Myalgia, Gastrooesophageal Reflux Disease, Muscle SpasmsAdditional drugs used concurrently: NA. Although Rosuvastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myalgia, may still occur.
Rosuvastatin Side Effect Report#9614322
Joint Swelling, Arthralgia
This Joint Swelling problem was reported by a pharmacist from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: hyperlipidaemia. On
Sep 21, 2011 this consumer started treatment with Rosuvastatin (dosage: 10mg At Bedtime Po). The following drugs were being taken at the same time: NA. When using Rosuvastatin, the patient experienced the following unwanted symptoms/side effects: Joint Swelling, ArthralgiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Joint Swelling, may become evident only after a product is in use by the general population.
Rosuvastatin Side Effect Report#9571135
Suicidal Ideation
This Suicidal Ideation side effect was reported by a pharmacist from US. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Rosuvastatin (drug dosage: NA), which was initiated on
May 21, 2013. Concurrently used drugs:
  • Ciprofloxacin
.After starting to take Rosuvastatin the consumer reported adverse symptoms, such as: Suicidal IdeationThese side effects may potentially be related to Rosuvastatin.
Rosuvastatin Side Effect Report#9565616
Renal Failure Acute, Presyncope
This is a report of a 64-year-old male patient (weight: NA) from AU, suffering from the following health symptoms/conditions: NA, who was treated with Rosuvastatin (dosage: NA, start time:
Sep 27, 2011), combined with:
  • Novorapid
  • Sotalol
  • Carvedilol
  • Inspra (50 Mg, Daily)
  • Metformin Hcl
  • Candesartan Cilexetil
  • Frusemide
  • Gliclazide
and developed a serious reaction and side effect(s): Renal Failure Acute, Presyncope after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rosuvastatin treatment in male patients, resulting in Renal Failure Acute side effect. The patient was hospitalized.
Rosuvastatin Side Effect Report#9562388
Nocturia
This report suggests a potential Rosuvastatin Nocturia side effect(s) that can have serious consequences. A 85-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: hypertension and used Rosuvastatin (dosage: NA) starting
May 24, 2010. After starting Rosuvastatin the patient began experiencing various side effects, including: NocturiaAdditional drugs used concurrently:
  • Amlodipine
  • Bendroflumethiazide
  • Cardura
Although Rosuvastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nocturia, may still occur.
Rosuvastatin Side Effect Report#9541618
Hyperglycaemia
This Hyperglycaemia problem was reported by a physician from US. A 65-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hyperlipidaemia. On
Aug 08, 2012 this consumer started treatment with Rosuvastatin (dosage: 10mg Qd Oral). The following drugs were being taken at the same time: NA. When using Rosuvastatin, the patient experienced the following unwanted symptoms/side effects: HyperglycaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hyperglycaemia, may become evident only after a product is in use by the general population.
Rosuvastatin Side Effect Report#9472254
Coronary Artery Occlusion, Off Label Use
This Coronary Artery Occlusion side effect was reported by a consumer or non-health professional from BR. A 77-year-old male patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Rosuvastatin (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Asa
  • Galvus Met
.After starting to take Rosuvastatin the consumer reported adverse symptoms, such as: Coronary Artery Occlusion, Off Label UseThese side effects may potentially be related to Rosuvastatin. The patient was hospitalized.
Rosuvastatin Side Effect Report#9457898
Rhabdomyolysis
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 Rosuvastatin (dosage: NA, start time:
Jun 15, 2007), combined with: NA. and developed a serious reaction and side effect(s): Rhabdomyolysis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rosuvastatin treatment in male patients, resulting in Rhabdomyolysis side effect. The patient was hospitalized.
Rosuvastatin Side Effect Report#9457527
Meningitis Eosinophilic
This report suggests a potential Rosuvastatin (rosuvastatin) Meningitis Eosinophilic side effect(s) that can have serious consequences. A 32-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Rosuvastatin (rosuvastatin) (dosage: NA) starting NS. After starting Rosuvastatin (rosuvastatin) the patient began experiencing various side effects, including: Meningitis EosinophilicAdditional drugs used concurrently:
  • Pioglitazone (pioglitazone)
  • Montelukast
  • Budesonide/formeterol(budesonide W/fumeterol)
  • Vancomycin ((not Otherwise Specified))
Although Rosuvastatin (rosuvastatin) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Meningitis Eosinophilic, may still occur.
Rosuvastatin Side Effect Report#9394335
Delirium, Renal Impairment, Rhabdomyolysis, Renal Failure Acute, Hypotension, Intestinal Haemorrhage
This Delirium problem was reported by a health professional from AU. A 83-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Rosuvastatin (dosage: NA). The following drugs were being taken at the same time:
  • Fusidic Acid
  • Rifampin
  • Metoprolol
  • Aspirin
  • Amlodipine
When using Rosuvastatin, the patient experienced the following unwanted symptoms/side effects: Delirium, Renal Impairment, Rhabdomyolysis, Renal Failure Acute, Hypotension, Intestinal HaemorrhageThe 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 Delirium, may become evident only after a product is in use by the general population.
Rosuvastatin Side Effect Report#9375635
Loss Of Consciousness, Myoglobin Blood Increased, Hepatic Enzyme Increased, Blood Creatine Phosphokinase Increased
This Loss Of Consciousness side effect was reported by a physician from CN. A male patient (weight:NA) experienced the following symptoms/conditions: cerebral infarction,hypertension.The patient was prescribed Rosuvastatin Calcium (drug dosage: NA), which was initiated on
Nov 15, 2012. Concurrently used drugs:
  • Amlodipine Besylate
.After starting to take Rosuvastatin Calcium the consumer reported adverse symptoms, such as: Loss Of Consciousness, Myoglobin Blood Increased, Hepatic Enzyme Increased, Blood Creatine Phosphokinase IncreasedThese side effects may potentially be related to Rosuvastatin Calcium.
Rosuvastatin Side Effect Report#9374065
Epilepsy
This is a report of a 68-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: blood cholesterol increased, who was treated with Rosuvastatin (dosage: NA, start time:
Jun 15, 2011), combined with:
  • Carbamazepine
  • Lamotrigine
  • Lisinopril And Hydrochlorothiazide
  • Terazosin
and developed a serious reaction and side effect(s): Epilepsy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rosuvastatin treatment in male patients, resulting in Epilepsy side effect.


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The appearance of Rosuvastatin 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 Rosuvastatin Side Effects for Women?

Women Side EffectsReports
Myalgia 18
Dyspnoea 12
Rhabdomyolysis 10
Cough 9
Diarrhoea 9
Interstitial Lung Disease 8
Autoimmune Hepatitis 7
Malaise 7
Pain In Extremity 7
Renal Failure Acute 7

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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.

    Rosuvastatin 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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    Rosuvastatin Safety Alerts, Active Ingredients, Usage Information

    More About Rosuvastatin

    Side Effects reported to FDA: 687

    Rosuvastatin safety alerts: 2005 2004

    Reported deaths: 30

    Reported hospitalizations: 245

    Crestor (rosuvastatin calicum)

    Audience: Physicians, pharmacists, and other healthcare professionals 

    FDA issued a public health advisory describing revisions to the WARNINGS, DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY, and PRECAUTIONS sections of the labeling. The revisions include results from a Phase 4 pharmacokinetic study in Asian-Americans and highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg. At this time, the FDA is also making statements about the muscle and kidney safety of Crestor based on extensive review of available information.

    [March 2, 2005 - Public Health Advisory - FDA]
    [March 2, 2005 - Drug Information Page - FDA]
    [January 2005 - Revised Label - Astra-Zeneca]

    Latest Rosuvastatin clinical trials