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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#9998213
Muscle Spasms, Myopathy, Neuropathy Peripheral, Sleep Disorder, Blood Glucose Increased
This is a report of a 48-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Pravastatin Sodium (dosage: NA, start time: 2005), combined with:
  • Atorvastatin Calcium
  • Simvastatin
  • Aspirin
  • Lantus
  • Novorapid
and developed a serious reaction and side effect(s): Muscle Spasms, Myopathy, Neuropathy Peripheral, Sleep Disorder, Blood Glucose Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin Sodium treatment in male patients, resulting in Muscle Spasms side effect.
Pravastatin Side Effect Report#9995798
Myalgia, Blood Glucose Increased
This report suggests a potential Pravastatin Myalgia side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hyperlipidaemia and used Pravastatin (dosage: 10 Mg Qhs/bedtime Oral) starting NS. After starting Pravastatin the patient began experiencing various side effects, including: Myalgia, Blood Glucose IncreasedAdditional drugs used concurrently: NA. Although Pravastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myalgia, may still occur.
Pravastatin Side Effect Report#9990780
Asthenia, Blood Creatine Phosphokinase Increased
This Asthenia problem was reported by a pharmacist from US. A 81-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 01, 2013 this consumer started treatment with Pravastatin (dosage: NA). The following drugs were being taken at the same time:
  • Multivitamins
When using Pravastatin, the patient experienced the following unwanted symptoms/side effects: Asthenia, Blood Creatine Phosphokinase IncreasedThe 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 Asthenia, may become evident only after a product is in use by the general population.
Pravastatin Side Effect Report#9982158
Myalgia
This Myalgia side effect was reported by a pharmacist from US. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: hyperlipidaemia.The patient was prescribed Pravastatin (drug dosage: NA), which was initiated on
Mar 05, 2009. Concurrently used drugs: NA..After starting to take Pravastatin the consumer reported adverse symptoms, such as: MyalgiaThese side effects may potentially be related to Pravastatin.
Pravastatin Side Effect Report#9981437
Muscle Spasms, Myopathy, Neuropathy Peripheral, Sleep Disorder, Blood Glucose Increased
This is a report of a 48-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Pravastatin Sodium (dosage: NA, start time: 2005), combined with:
  • Atorvastatin Calcium
  • Simvastatin
  • Aspirin
  • Lantus
  • Novorapid
and developed a serious reaction and side effect(s): Muscle Spasms, Myopathy, Neuropathy Peripheral, Sleep Disorder, Blood Glucose Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin Sodium treatment in male patients, resulting in Muscle Spasms side effect.
Pravastatin Side Effect Report#9971653
Activities Of Daily Living Impaired, Muscle Disorder, Back Pain, Muscular Weakness, Insomnia, Discomfort, Dysstasia, Pain, Feeling Abnormal
This report suggests a potential Pravastatin Activities Of Daily Living Impaired 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: blood cholesterol increased and used Pravastatin (dosage: 1 Pill Once Daily Taken By Mouth) starting
Jan 01, 2002. After starting Pravastatin the patient began experiencing various side effects, including: Activities Of Daily Living Impaired, Muscle Disorder, Back Pain, Muscular Weakness, Insomnia, Discomfort, Dysstasia, Pain, Feeling AbnormalAdditional drugs used concurrently: NA. Although Pravastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Activities Of Daily Living Impaired, may still occur.
Pravastatin Side Effect Report#9971564
Memory Impairment
This Memory Impairment problem was reported by a consumer or non-health professional from US. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood cholesterol increased. On
Jan 30, 2014 this consumer started treatment with Pravastatin Sodium (dosage: One Tablet). The following drugs were being taken at the same time: NA. When using Pravastatin Sodium, the patient experienced the following unwanted symptoms/side effects: Memory ImpairmentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Memory Impairment, may become evident only after a product is in use by the general population.
Pravastatin Side Effect Report#9969745
Headache, Haemorrhage, Dizziness, Purulence, Erectile Dysfunction, Erectile Dysfunction, Loss Of Libido, Sinus Disorder, Inflammation
This Headache side effect was reported by a consumer or non-health professional from US. A 61-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypercholesterolaemia.The patient was prescribed Pravastatin Sodium (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Valium 100266901/
  • Crestor
  • Lyrica
.After starting to take Pravastatin Sodium the consumer reported adverse symptoms, such as: Headache, Haemorrhage, Dizziness, Purulence, Erectile Dysfunction, Erectile Dysfunction, Loss Of Libido, Sinus Disorder, InflammationThese side effects may potentially be related to Pravastatin Sodium.
Pravastatin Side Effect Report#9960260
Nausea, Product Substitution Issue
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Pravastatin 80mg (dosage: NA, start time: NS), combined with:
  • Norgestimate And Ethinyl Estradiol
and developed a serious reaction and side effect(s): Nausea, Product Substitution Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin 80mg treatment in female patients, resulting in Nausea side effect.
Pravastatin Side Effect Report#9925461
Pain, Chromaturia, Back Pain, Arthralgia
This report suggests a potential Pravastatin Pain side effect(s) that can have serious consequences. A 59-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hyperlipidaemia and used Pravastatin (dosage: NA) starting
Jun 04, 2012. After starting Pravastatin the patient began experiencing various side effects, including: Pain, Chromaturia, Back Pain, ArthralgiaAdditional drugs used concurrently: NA. Although Pravastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain, may still occur.
Pravastatin Side Effect Report#9921873
Pain, Product Substitution Issue
This Pain problem was reported by a consumer or non-health professional from US. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood cholesterol. On NS this consumer started treatment with Pravastatin (dosage: NA). The following drugs were being taken at the same time:
  • Lisopril
  • Provastatin
  • Allopurinol
  • Vesicare
  • Vitamin A, D And C
  • Niacin
  • Asprin
When using Pravastatin, the patient experienced the following unwanted symptoms/side effects: Pain, Product Substitution IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pain, may become evident only after a product is in use by the general population.
Pravastatin Side Effect Report#9916199
Pruritus
This Pruritus side effect was reported by a consumer or non-health professional from US. A 73-year-old patient (weight:NA) experienced the following symptoms/conditions: blood cholesterol increased.The patient was prescribed Pravastatin Sodium (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Pravastatin Sodium the consumer reported adverse symptoms, such as: PruritusThese side effects may potentially be related to Pravastatin Sodium.
Pravastatin Side Effect Report#9913350
Arthralgia, Joint Stiffness, Myalgia
This is a report of a 61-year-old male patient (weight: NA) from ES, suffering from the following health symptoms/conditions: NA, who was treated with Pravastatin (dosage: NA, start time: NS), combined with:
  • Sitagliptin
and developed a serious reaction and side effect(s): Arthralgia, Joint Stiffness, Myalgia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin treatment in male patients, resulting in Arthralgia side effect.
Pravastatin Side Effect Report#9912836
Headache, Middle Insomnia
This report suggests a potential Pravastatin Headache side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood cholesterol increased and used Pravastatin (dosage: 1) starting
Jan 22, 2014. After starting Pravastatin the patient began experiencing various side effects, including: Headache, Middle InsomniaAdditional drugs used concurrently: NA. Although Pravastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Headache, may still occur.
Pravastatin Side Effect Report#9912713
Arthralgia, Joint Stiffness, Myalgia
This Arthralgia problem was reported by a consumer or non-health professional from ES. A 61-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:
  • Sitagliptin
When using Pravastatin, the patient experienced the following unwanted symptoms/side effects: Arthralgia, Joint Stiffness, MyalgiaAlthough 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#9908539
Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
This Aspartate Aminotransferase Increased side effect was reported by a pharmacist from US. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: hyperlipidaemia.The patient was prescribed Pravastatin (drug dosage: NA), which was initiated on
Aug 21, 2013. Concurrently used drugs: NA..After starting to take Pravastatin the consumer reported adverse symptoms, such as: Aspartate Aminotransferase Increased, Alanine Aminotransferase IncreasedThese side effects may potentially be related to Pravastatin.
Pravastatin Side Effect Report#9904185
Coeliac Disease
This is a report of a 66-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: hypercholesterolaemia, who was treated with Pravastatin Sodium Tablets Usp 80 Mg (dosage: NA, start time:
Nov 11, 2013), combined with:
  • Omeprazole
  • Benicar
  • Januvia
  • Fenofibrate
  • Amlodipine
  • Hydrochlorothiazide
and developed a serious reaction and side effect(s): Coeliac Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin Sodium Tablets Usp 80 Mg treatment in female patients, resulting in Coeliac Disease side effect.
Pravastatin Side Effect Report#9879401
Pruritus, Liver Function Test Abnormal
This report suggests a potential Pravastatin Pruritus side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Pravastatin (dosage: NA) starting
Dec 27, 2013. After starting Pravastatin the patient began experiencing various side effects, including: Pruritus, Liver Function Test AbnormalAdditional drugs used concurrently:
  • Doxazosin
  • Losartan
  • Simvastatin
  • Ciprofloxacin
  • Zopiclone
  • Menthol
  • Colchicine
Although Pravastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pruritus, may still occur.
Pravastatin Side Effect Report#9855421
Nausea, Retching, Myalgia, Muscular Weakness, Muscle Atrophy, Transaminases Increased
This Nausea problem was reported by a health professional from DE. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypercholesterolaemia. On 2008 this consumer started treatment with Pravastatin (dosage: Niedrigste Dosierung). The following drugs were being taken at the same time:
  • Simvastatin (Niedrigste Dosierung)
  • Atorvastatin (Niedrigste Dosierung)
  • Fluvastatin (Niedrigste Dosierung)
  • Ezetimibe (Niedrigste Dosierung)
  • Gemfibrozil (Niedrigste Dosierung)
When using Pravastatin, the patient experienced the following unwanted symptoms/side effects: Nausea, Retching, Myalgia, Muscular Weakness, Muscle Atrophy, Transaminases IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Pravastatin Side Effect Report#9853369
Rhabdomyolysis, Renal Failure, Myalgia, Dyspnoea
This Rhabdomyolysis side effect was reported by a health professional from FR. A 77-year-old male patient (weight:NA) experienced the following symptoms/conditions: cardiac failure.The patient was prescribed Pravastatin Sandoz (drug dosage: 40 Mg, Qd), which was initiated on 2007. Concurrently used drugs:
  • Amlodipine Sandoz (5 Mg, Qd)
  • Previscan//fluindione
  • Adancor (20 Mg, Bid)
  • Omeprazol E (20 Mg, Qd)
  • Avodart (0.5 Mg, Qd)
.After starting to take Pravastatin Sandoz the consumer reported adverse symptoms, such as: Rhabdomyolysis, Renal Failure, Myalgia, DyspnoeaThese side effects may potentially be related to Pravastatin Sandoz. The patient was hospitalized.
Pravastatin Side Effect Report#9841402
Pollakiuria, Urinary Hesitation, Renal Pain, Product Substitution Issue
This is a report of a 57-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: blood cholesterol increased, who was treated with Pravastatin (dosage: One Tablet Qhs/bedtime Oral, start time: NS), combined with:
  • Metoprolol Succinate
and developed a serious reaction and side effect(s): Pollakiuria, Urinary Hesitation, Renal Pain, Product Substitution Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin treatment in male patients, resulting in Pollakiuria side effect.
Pravastatin Side Effect Report#9826142
Pain In Extremity, Asthenia, Balance Disorder, Muscular Weakness
This report suggests a potential Pravastatin Pain In Extremity side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood cholesterol increased and used Pravastatin (dosage: 1/2 Pill Of 10mg) starting
Feb 16, 2012. After starting Pravastatin the patient began experiencing various side effects, including: Pain In Extremity, Asthenia, Balance Disorder, Muscular WeaknessAdditional drugs used concurrently: NA. 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#9791577
Depressed Mood, Myalgia, Abdominal Pain Upper, Fatigue, Tinnitus, Senile Dementia
This Depressed Mood problem was reported by a consumer or non-health professional from NL. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood cholesterol increased. On
Feb 23, 2009 this consumer started treatment with Pravastatine Tabs 20 Mg (dosage: NA). The following drugs were being taken at the same time:
  • Valsartan (80mg Coated Tablet)
  • Inspra (Tabs)
  • Bisoprolol Fumarate
  • Bisoprolol Fumarate
When using Pravastatine Tabs 20 Mg, the patient experienced the following unwanted symptoms/side effects: Depressed Mood, Myalgia, Abdominal Pain Upper, Fatigue, Tinnitus, Senile DementiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Depressed Mood, may become evident only after a product is in use by the general population.
Pravastatin Side Effect Report#9785724
Musculoskeletal Chest Pain, Back Pain, Musculoskeletal Pain
This Musculoskeletal Chest Pain side effect was reported by a consumer or non-health professional from US. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: hyperlipidaemia,hypertension.The patient was prescribed Pravastatin Sodium (drug dosage: NA), which was initiated on
Nov 07, 2007. Concurrently used drugs:
  • Atenolol
  • Amlodipine Besylate
  • Equate
  • Cod Liver Oil
  • Vitamin C
  • Co Q 10
  • Probiotic
  • Calcium Citrate +d
.After starting to take Pravastatin Sodium the consumer reported adverse symptoms, such as: Musculoskeletal Chest Pain, Back Pain, Musculoskeletal PainThese side effects may potentially be related to Pravastatin Sodium.
Pravastatin Side Effect Report#9784068
Fatigue, Myalgia, Hypoaesthesia, Pain
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:
Aug 23, 2013), combined with:
  • Alfacalcidol
  • Bisoprolol
  • Felodipine
  • Furosemide
  • Moxonidine
  • Ramipril
  • Spironolactone
  • Bisoprolol
and developed a serious reaction and side effect(s): Fatigue, Myalgia, Hypoaesthesia, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pravastatin treatment in male patients, resulting in Fatigue 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.

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