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Pravastatin Side Effects

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Common Pravastatin Side Effects


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

Myalgia (194)
Dizziness (81)
Fatigue (80)
Arthralgia (79)
Nausea (77)
Pain In Extremity (75)
Rhabdomyolysis (74)
Muscular Weakness (71)
Asthenia (71)
Pain (67)
Muscle Spasms (66)
Diarrhoea (58)
Dyspnoea (48)
Malaise (45)
Renal Failure Acute (42)
Anaemia (41)
Pruritus (41)
Colitis (41)
Back Pain (39)
Gait Disturbance (35)

➢ 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.

Pravastatin Side Effects Reported to FDA



Pravastatin Side Effect Report#9783549
Myalgia, Pain, Hypoaesthesia, Fatigue
This is a report of a 61-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Pravastatin (dosage: NA, start time:
Oct 18, 2013), combined with:
  • Statins
  • Alfacalcidol
  • Bisoprolol
  • Bisoprolol
  • Felodipine
  • Felodipine
  • Furosemide
  • Furosemide
and developed a serious reaction and side effect(s): Myalgia, Pain, Hypoaesthesia, Fatigue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin treatment in male patients, resulting in Myalgia side effect.
Pravastatin Side Effect Report#9778436
Muscle Spasms
This report suggests a potential Pravastatin Muscle Spasms side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: atrial fibrillation and used Pravastatin (dosage: NA) starting NS. After starting Pravastatin the patient began experiencing various side effects, including: Muscle SpasmsAdditional drugs used concurrently: NA. Although Pravastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Muscle Spasms, may still occur.
Pravastatin Side Effect Report#9777942
Myalgia, Hypoaesthesia, Pain, Fatigue
This Myalgia problem was reported by a consumer or non-health professional from GB. A 61-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 18, 2013 this consumer started treatment with Pravastatin Sodium (dosage: NA). The following drugs were being taken at the same time:
  • Alfacalcidol
  • Bisoprolol
  • Bisoprolol
  • Felodipine
  • Felodipine
  • Furosemide
  • Furosemide
  • Moxonidine
When using Pravastatin Sodium, the patient experienced the following unwanted symptoms/side effects: Myalgia, Hypoaesthesia, Pain, FatigueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myalgia, may become evident only after a product is in use by the general population.
Pravastatin Side Effect Report#9769445
Respiratory Tract Infection
This Respiratory Tract Infection side effect was reported by a consumer or non-health professional from US. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: blood cholesterol increased.The patient was prescribed Pravastatin Sodium (drug dosage: NA), which was initiated on
Aug 12, 2009. Concurrently used drugs:
  • Holy Basil
  • Aspirin
  • Lung Formula
  • Vita Digest
  • Mahasudarsham
.After starting to take Pravastatin Sodium the consumer reported adverse symptoms, such as: Respiratory Tract InfectionThese side effects may potentially be related to Pravastatin Sodium.
Pravastatin Side Effect Report#9752478
Joint Range Of Motion Decreased, Liver Function Test Abnormal, Myalgia, Arthralgia, Liver Injury, Neuropathy Peripheral
This is a report of a 56-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: low density lipoprotein increased, who was treated with Pravastatin Sodium (dosage: NA, start time:
Jun 10, 2009), combined with:
  • Atenolol
  • Amlodipine Besylate
  • Fish Oil
and developed a serious reaction and side effect(s): Joint Range Of Motion Decreased, Liver Function Test Abnormal, Myalgia, Arthralgia, Liver Injury, Neuropathy Peripheral after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin Sodium treatment in male patients, resulting in Joint Range Of Motion Decreased side effect.
Pravastatin Side Effect Report#9734973
Pain In Extremity, Paraesthesia, Musculoskeletal Pain
This report suggests a potential Pravastatin Pain In Extremity side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Pravastatin (dosage: NA) starting NS. After starting Pravastatin the patient began experiencing various side effects, including: Pain In Extremity, Paraesthesia, Musculoskeletal PainAdditional drugs used concurrently:
  • Liraglutide
  • Metformin
  • Rabeprazole
  • Ramipril
  • Vesicare
Although Pravastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain In Extremity, may still occur.
Pravastatin Side Effect Report#9732218
Muscle Fatigue, Muscle Atrophy, Fatigue, Sleep Disorder, Constipation, Oedema Mouth, Pain, Myalgia
This Muscle Fatigue problem was reported by a consumer or non-health professional from GB. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood cholesterol increased. On 2005 this consumer started treatment with Pravastatin (dosage: 1 Dosage Forms Daily;). The following drugs were being taken at the same time:
  • Simvastatin (1 Dosage Forms Daily;)
  • Rosuvastatin (1 Dosage Forms Daily;)
  • Atorvastatin (1 Dosage Forms Daily;)
  • Lipitor (1 Dosage Forms Daily;)
  • Fenofibrate (1 Dosage Forms Daily;)
  • Ezetimibe (1 Dosage Forms Daily;)
When using Pravastatin, the patient experienced the following unwanted symptoms/side effects: Muscle Fatigue, Muscle Atrophy, Fatigue, Sleep Disorder, Constipation, Oedema Mouth, Pain, MyalgiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Muscle Fatigue, may become evident only after a product is in use by the general population.
Pravastatin Side Effect Report#9731403
Muscle Spasms, Migraine, Amnesia, Pain, Oedema Peripheral, Balance Disorder, Asthenia, Muscular Weakness, Speech Disorder
This Muscle Spasms side effect was reported by a consumer or non-health professional from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: blood cholesterol increased.The patient was prescribed Pravastatin Sodium (drug dosage: 1 Tab), which was initiated on NS. Concurrently used drugs:
  • Loratadine
  • Omeprazole
  • Aspirin
  • Cholestyramine
  • Prilosec
.After starting to take Pravastatin Sodium the consumer reported adverse symptoms, such as: Muscle Spasms, Migraine, Amnesia, Pain, Oedema Peripheral, Balance Disorder, Asthenia, Muscular Weakness, Speech DisorderThese side effects may potentially be related to Pravastatin Sodium. The patient was hospitalized.
Pravastatin Side Effect Report#9730387
Rhabdomyolysis, Renal Failure Acute, Blood Creatinine Increased
This is a report of a 90-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Pravastatin Sodium (dosage: NA, start time: NS), combined with:
  • Omeprazole
  • Metformin
  • Furosemide
  • Ditropan
  • Gliclazide
  • Tramadol
  • Voltarene
  • Mianserine
and developed a serious reaction and side effect(s): Rhabdomyolysis, Renal Failure Acute, Blood Creatinine Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin Sodium treatment in female patients, resulting in Rhabdomyolysis side effect. The patient was hospitalized.
Pravastatin Side Effect Report#9726336
Accident, Dizziness, Liver Disorder, Heart Rate Decreased, Therapeutic Response Unexpected
This report suggests a potential Pravastatin Sodium Accident side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood cholesterol abnormal,bladder disorder and used Pravastatin Sodium (dosage: 40 Mg, Daily) starting NS. After starting Pravastatin Sodium the patient began experiencing various side effects, including: Accident, Dizziness, Liver Disorder, Heart Rate Decreased, Therapeutic Response UnexpectedAdditional drugs used concurrently:
  • Detrol La (2 Mg, Two Times A Day)
  • Detrol La (4 Mg, Daily)
  • Levothyroxine (125 Ug, Daily)
  • Tramadol (Unk, As Needed)
Although Pravastatin Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Accident, may still occur.
Pravastatin Side Effect Report#9725723
Arthralgia, Pain In Jaw, Fatigue
This Arthralgia problem was reported by a physician from Country Not Specified. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Pravastatin (dosage: NA). The following drugs were being taken at the same time:
  • Tadalafil
  • Zolpidem
  • Ranitidine
  • Lisinopril
When using Pravastatin, the patient experienced the following unwanted symptoms/side effects: Arthralgia, Pain In Jaw, FatigueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arthralgia, may become evident only after a product is in use by the general population.
Pravastatin Side Effect Report#9725282
Muscle Spasms, Condition Aggravated, Activities Of Daily Living Impaired, Gait Disturbance, Mobility Decreased, Impaired Driving Ability, Stress, Walking Aid User, Walking Aid User
This Muscle Spasms side effect was reported by a consumer or non-health professional from US. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: blood cholesterol increased.The patient was prescribed Pravastatin Sodium (drug dosage: NA), which was initiated on
Sep 20, 2013. Concurrently used drugs: NA..After starting to take Pravastatin Sodium the consumer reported adverse symptoms, such as: Muscle Spasms, Condition Aggravated, Activities Of Daily Living Impaired, Gait Disturbance, Mobility Decreased, Impaired Driving Ability, Stress, Walking Aid User, Walking Aid UserThese side effects may potentially be related to Pravastatin Sodium.
Pravastatin Side Effect Report#9720946
Cerebrovascular Accident
This is a report of a 48-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Pravastatin Sodium (dosage: NA, start time: NS), combined with:
  • Cortisone Acetate
  • Neurontin
  • Lyrica
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 Pravastatin Sodium treatment in male patients, resulting in Cerebrovascular Accident side effect.
Pravastatin Side Effect Report#9712510
Pain, Pain In Extremity, Insomnia, Product Substitution Issue, Product Quality Issue
This report suggests a potential Pravastatin Pain side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood cholesterol increased and used Pravastatin (dosage: Tablet) starting
Oct 20, 2013. After starting Pravastatin the patient began experiencing various side effects, including: Pain, Pain In Extremity, Insomnia, Product Substitution Issue, Product Quality IssueAdditional drugs used concurrently:
  • Glucosamine Hcl
  • Calcium Citrate
  • Dhea
  • Melatonin
  • Fish Oil
Although Pravastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain, may still occur.
Pravastatin Side Effect Report#9708067
Urticaria, Swelling Face
This Urticaria problem was reported by a consumer or non-health professional from US. A 59-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: blood cholesterol increased. On NS this consumer started treatment with Pravastatin (dosage: NA). The following drugs were being taken at the same time: NA. When using Pravastatin, the patient experienced the following unwanted symptoms/side effects: Urticaria, Swelling FaceAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Urticaria, may become evident only after a product is in use by the general population.
Pravastatin Side Effect Report#9704274
Peripheral Artery Stenosis, Blood Creatine Phosphokinase Increased, Rheumatoid Factor Increased, Musculoskeletal Pain, Joint Stiffness
This Peripheral Artery Stenosis side effect was reported by a physician from GB. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: peripheral vascular disorder,blood cholesterol,chronic myeloid leukaemia.The patient was prescribed Pravastatin (drug dosage: NA), which was initiated on
Aug 05, 2009. Concurrently used drugs: NA..After starting to take Pravastatin the consumer reported adverse symptoms, such as: Peripheral Artery Stenosis, Blood Creatine Phosphokinase Increased, Rheumatoid Factor Increased, Musculoskeletal Pain, Joint StiffnessThese side effects may potentially be related to Pravastatin.
Pravastatin Side Effect Report#9702197
Blood Creatine Phosphokinase Increased, Joint Stiffness, Musculoskeletal Pain, Rheumatoid Factor Increased, Peripheral Artery Stenosis
This is a report of a 46-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: blood cholesterol,peripheral vascular disorder,chronic myeloid leukaemia, who was treated with Pravastatin (dosage: NA, start time:
Aug 05, 2009), combined with: NA. and developed a serious reaction and side effect(s): Blood Creatine Phosphokinase Increased, Joint Stiffness, Musculoskeletal Pain, Rheumatoid Factor Increased, Peripheral Artery Stenosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin treatment in male patients, resulting in Blood Creatine Phosphokinase Increased side effect.
Pravastatin Side Effect Report#9702196
Blood Creatine Phosphokinase Increased, Joint Stiffness, Musculoskeletal Pain, Rheumatoid Factor Increased, Peripheral Artery Stenosis
This report suggests a potential Pravastatin Blood Creatine Phosphokinase Increased side effect(s) that can have serious consequences. A 46-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: blood cholesterol,peripheral vascular disorder,chronic myeloid leukaemia and used Pravastatin (dosage: NA) starting
Aug 05, 2009. After starting Pravastatin the patient began experiencing various side effects, including: Blood Creatine Phosphokinase Increased, Joint Stiffness, Musculoskeletal Pain, Rheumatoid Factor Increased, Peripheral Artery StenosisAdditional drugs used concurrently: NA. Although Pravastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Creatine Phosphokinase Increased, may still occur.
Pravastatin Side Effect Report#9691112
Raynaud^s Phenomenon, Erythema
This Raynaud^s Phenomenon problem was reported by a consumer or non-health professional from GB. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201103 this consumer started treatment with Pravastatin Sodium (dosage: Started In Hospital). The following drugs were being taken at the same time:
  • Pradaxa (Stopped When Patient In Hospital.)
  • Bisoprolol (Started In Hopsital)
  • Amlodipine (Continuing.)
  • Clopidogrel Bisulfate (Started In Hospital)
When using Pravastatin Sodium, the patient experienced the following unwanted symptoms/side effects: Raynaud^s Phenomenon, ErythemaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Raynaud^s Phenomenon, may become evident only after a product is in use by the general population.
Pravastatin Side Effect Report#9688932
Peripheral Artery Stenosis, Rheumatoid Factor Increased, Joint Stiffness, Musculoskeletal Pain, Blood Creatine Phosphokinase Increased
This Peripheral Artery Stenosis side effect was reported by a health professional from GB. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: peripheral vascular disorder,blood cholesterol,chronic myeloid leukaemia.The patient was prescribed Pravastatin Sodium (drug dosage: NA), which was initiated on
Aug 05, 2009. Concurrently used drugs: NA..After starting to take Pravastatin Sodium the consumer reported adverse symptoms, such as: Peripheral Artery Stenosis, Rheumatoid Factor Increased, Joint Stiffness, Musculoskeletal Pain, Blood Creatine Phosphokinase IncreasedThese side effects may potentially be related to Pravastatin Sodium.
Pravastatin Side Effect Report#9686347
Raynaud^s Phenomenon, Erythema
This is a report of a 78-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Pravastatin (dosage: Started In Hospital, start time: 201103), combined with:
  • Bisoprolol (Started In Hopsital)
  • Pradaxa (220 Milligram Daily; Stopped When Patient In Hospital)
  • Amlodipine (Continuing)
  • Clopidogrel (Started In Hospital)
and developed a serious reaction and side effect(s): Raynaud^s Phenomenon, Erythema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin treatment in female patients, resulting in Raynaud^s Phenomenon side effect.
Pravastatin Side Effect Report#9683696
Hepatic Failure
This report suggests a potential Pravastatin Hepatic Failure side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood cholesterol and used Pravastatin (dosage: NA) starting NS. After starting Pravastatin the patient began experiencing various side effects, including: Hepatic FailureAdditional drugs used concurrently: NA.The patient was hospitalized. Although Pravastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Failure, may still occur.
Pravastatin Side Effect Report#9681917
Raynaud^s Phenomenon, Erythema
This Raynaud^s Phenomenon problem was reported by a health professional from GB. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201103 this consumer started treatment with Pravastatin (dosage: 40 Mg, Unk). The following drugs were being taken at the same time:
  • Bisoprolol (2.5 Mg, Unk)
  • Pradaxa (110 Mg, Bid, Stopped When In Hospital)
  • Amlodipine (5 Mg, Unk)
  • Clopidogrel (75 Mg, Unk)
When using Pravastatin, the patient experienced the following unwanted symptoms/side effects: Raynaud^s Phenomenon, ErythemaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Raynaud^s Phenomenon, may become evident only after a product is in use by the general population.
Pravastatin Side Effect Report#9672349
Bone Marrow Failure, Petechiae, Oral Pain, Tongue Haemorrhage, Fatigue
This Bone Marrow Failure side effect was reported by a physician from FI. A 85-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Pravastatin Ratiopharm 40 Mg (drug dosage: 40 Milligram Daily;), which was initiated on
Oct 04, 2013. Concurrently used drugs:
  • Ipramol (1 Dosage Form = Albuterol Sulfate 2.5 Mg + Ipratropium Bromide 0.5 Mg; 4-6 Times Per Day)
  • Nasofan (100 Microgram Daily;)
  • Norspan 10microg/h (240 Microgram Daily;)
  • Somac 20mg (20 Milligram Daily; During Cortisone Course)
  • Litalgin (2 Tablet Daily; 1-2 Times A Day)
  • Vi-siblin
  • Diformin Retard 500mg (1000 Milligram Daily;)
  • Pradaxa 110mg (220 Milligram Daily;)
.After starting to take Pravastatin Ratiopharm 40 Mg the consumer reported adverse symptoms, such as: Bone Marrow Failure, Petechiae, Oral Pain, Tongue Haemorrhage, FatigueThese side effects may potentially be related to Pravastatin Ratiopharm 40 Mg.
Pravastatin Side Effect Report#9665854
Nephrolithiasis, Calculus Ureteric, Hypoaesthesia, Hypoaesthesia, No Therapeutic Response
This is a report of a 63-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: blood cholesterol increased, who was treated with Pravastatin (dosage: NA, start time:
Dec 21, 2012), combined with:
  • Metoprolol Er Succinate
  • Amlodipine Besylate
  • B-complex
  • Vitc
  • Acetaminophen
and developed a serious reaction and side effect(s): Nephrolithiasis, Calculus Ureteric, Hypoaesthesia, Hypoaesthesia, No Therapeutic Response after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin treatment in female patients, resulting in Nephrolithiasis side effect.


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The appearance of Pravastatin 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.

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What are common Pravastatin Side Effects for Women?

Women Side EffectsReports
Myalgia 81
Pain In Extremity 46
Arthralgia 45
Dizziness 45
Nausea 44
Asthenia 41
Diarrhoea 40
Fatigue 40
Colitis 39
Muscular Weakness 36

What are common Pravastatin Side Effects for Men?

Men Side EffectsReports
Myalgia 112
Rhabdomyolysis 59
Fatigue 40
Dizziness 36
Renal Failure Acute 35
Arthralgia 34
Muscular Weakness 33
Nausea 32
Asthenia 30
Muscle Spasms 30

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.

    Pravastatin 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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    Pravastatin Safety Alerts, Active Ingredients, Usage Information

    NDC0093-0771
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NamePravastatin Sodium
    NamePravastatin Sodium
    Dosage FormTABLET
    RouteORAL
    On market since20060425
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)PRAVASTATIN SODIUM
    Strength(s)10
    Unit(s)mg/1
    Pharma ClassHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

    Pravastatin Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1589

    Pravastatin safety alerts: No

    Reported deaths: 52

    Reported hospitalizations: 294

    Latest Pravastatin clinical trials