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Pravastatin Side Effects

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.

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.

Pravastatin Side Effects Reported to FDA

The following 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.


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.
Myalgia, Pain, Hypoaesthesia, Fatigue
This is a report of a 61-year-old male patient (weight: NA) from GB, suffering from the following 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). The consumer presented with:
  • Myalgia
  • Pain
  • Hypoaesthesia
  • Fatigue
which developed 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.

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. Soon after starting Pravastatin the patient began experiencing various side effects, including:
  • Muscle Spasms
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.

Myalgia, Hypoaesthesia, Pain, Fatigue
This Myalgia, Hypoaesthesia, Pain, Fatigue 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 commencing Pravastatin Sodium, the patient experienced the following unwanted symptoms/side effects:
  • Myalgia
  • Hypoaesthesia
  • Pain
  • Fatigue
Although 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.

Respiratory Tract Infection
This is a report of a 59-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: blood cholesterol increased and was treated with Pravastatin Sodium (dosage: NA) starting Aug 12, 2009. Concurrently used drugs:
  • Holy Basil
  • Aspirin
  • Lung Formula
  • Vita Digest
  • Mahasudarsham
Soon after that, the consumer experienced the following side effects:
  • Respiratory Tract Infection
This opens a possibility that Pravastatin Sodium treatment could cause the above reactions, including respiratory tract infection, and some male subjects may be more susceptible.


Joint Range Of Motion Decreased, Liver Function Test Abnormal, Myalgia, Arthralgia, Liver Injury, Neuropathy Peripheral
A 56-year-old male patient (weight: NA) from US with the following symptoms/conditions: low density lipoprotein increased started Pravastatin Sodium treatment (dosage: NA) on Jun 10, 2009. Soon after starting Pravastatin Sodium treatment, the subject experienced various side effects, including:
  • Joint Range Of Motion Decreased
  • Liver Function Test Abnormal
  • Myalgia
  • Arthralgia
  • Liver Injury
  • Neuropathy Peripheral
Concurrently used drugs:
  • Atenolol
  • Amlodipine Besylate
  • Fish Oil
This finding indicates that some male patients could be more vulnerable to Pravastatin Sodium.

Pain In Extremity, Paraesthesia, Musculoskeletal Pain
A 57-year-old female patient from GB (weight: NA) experienced symptoms, such as: NA and was treated with Pravastatin(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Pain In Extremity
  • Paraesthesia
  • Musculoskeletal Pain
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Pravastatin efficacy:
  • Liraglutide
  • Metformin
  • Rabeprazole
  • Ramipril
  • Vesicare


Muscle Fatigue, Muscle Atrophy, Sleep Disorder, Constipation, Oedema Mouth, Pain, Myalgia
In this report, Pravastatin was administered for the following condition: blood cholesterol increased.A 78-year-old male consumer from GB (weight: NA) started Pravastatin treatment (dosage: 1 Dosage Forms Daily;) on 2005.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Muscle Fatigue
  • Muscle Atrophy
  • Sleep Disorder
  • Constipation
  • Oedema Mouth
  • Pain
  • Myalgia
A possible interaction with other drugs could have contributed to this reaction:
  • 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;)
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Pravastatin treatment could be related to the listed above side effect(s).

Muscle Spasms, Migraine, Amnesia, Pain, Oedema Peripheral, Balance Disorder, Asthenia, Muscular Weakness, Speech Disorder
This is a report of the following Pravastatin Sodium side effect(s):
  • Muscle Spasms
  • Migraine
  • Amnesia
  • Pain
  • Oedema Peripheral
  • Balance Disorder
  • Asthenia
  • Muscular Weakness
  • Speech Disorder
A 47-year-old female patient from US (weight: NA) presented with the following condition: blood cholesterol increased and received a treatment with Pravastatin Sodium (dosage: 1 Tab) starting: NS.The following concurrently used drugs could have generated interactions:
  • Loratadine
  • Omeprazole
  • Aspirin
  • Cholestyramine
  • Prilosec
The patient was hospitalized.This report suggests that a Pravastatin Sodium treatment could be associated with the listed above side effect(s).

Rhabdomyolysis, Renal Failure Acute, Blood Creatinine Increased
This Pravastatin Sodium report was submitted by a 90-year-old female consumer from FR (weight: NA). The patient was diagnosed with: NA and Pravastatin Sodium was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Rhabdomyolysis
  • Renal Failure Acute
  • Blood Creatinine Increased
Other drugs used simultaneously:
  • Omeprazole
  • Metformin
  • Furosemide
  • Ditropan
  • Gliclazide
  • Tramadol
  • Voltarene
  • Mianserine
The patient was hospitalized.Those unexpected symptoms could be linked to a Pravastatin Sodium treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Accident, Dizziness, Liver Disorder, Heart Rate Decreased, Therapeutic Response Unexpected
This is a report of a possible correlation between Pravastatin Sodium use and the following symptoms/side effect(s):
  • Accident
  • Dizziness
  • Liver Disorder
  • Heart Rate Decreased
  • Therapeutic Response Unexpected
which could contribute to an assessment of Pravastatin Sodium risk profile.A 62-year-old female consumer from US (weight: NA) was suffering from blood cholesterol abnormal,bladder disorder and was treated with Pravastatin Sodium (dosage: 40 Mg, Daily) starting NS.Other concurrent medications:
  • Detrol La (2 Mg, Two Times A Day)
  • Detrol La (4 Mg, Daily)
  • Levothyroxine (125 Ug, Daily)
  • Tramadol (Unk, As Needed)


Arthralgia, Pain In Jaw, Fatigue
A 59-year-old male patient from COUNTRY NOT SPECIFIED (weight: NA) presented with the following symptoms: NA and after a treatment with Pravastatin (dosage: NA) experienced the following side effect(s):
  • Arthralgia
  • Pain In Jaw
  • Fatigue
The treatment was started on NS. Pravastatin was used in combination with the following drugs:
  • Tadalafil
  • Zolpidem
  • Ranitidine
  • Lisinopril
This report could alert potential Pravastatin consumers.

Muscle Spasms, Condition Aggravated, Activities Of Daily Living Impaired, Gait Disturbance, Mobility Decreased, Impaired Driving Ability, Stress, Walking Aid User
In this report, a 70-year-old female patient from US (weight: NA) was affected by a possible Pravastatin Sodium side effect.The patient was diagnosed with blood cholesterol increased. After a treatment with Pravastatin Sodium (dosage: NA, start date: Sep 20, 2013), the patient experienced the following side effect(s):
  • Muscle Spasms
  • Condition Aggravated
  • Activities Of Daily Living Impaired
  • Gait Disturbance
  • Mobility Decreased
  • Impaired Driving Ability
  • Stress
  • Walking Aid User
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Pravastatin Sodium treatment.

Cerebrovascular Accident
This is a report of a 48-year-old male patient from US (weight: NA), who used Pravastatin Sodium (dosage: NA) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Cerebrovascular Accident
The following drugs could possibly have interacted with the Pravastatin Sodium treatment
  • Cortisone Acetate
  • Neurontin
  • Lyrica
Taken together, these observations suggest that a Pravastatin Sodium treatment could be related to side effect(s), such as Cerebrovascular Accident.

Pain, Pain In Extremity, Insomnia, Product Substitution Issue, Product Quality Issue
This pain side effect was reported by a consumer or non-health professional from US. A 77-year-old male patient (weight:NA) experienced the following symptoms/conditions: blood cholesterol increased. The patient was prescribed Pravastatin (dosage: Tablet), which was started on Oct 20, 2013. Concurrently used drugs:
  • Glucosamine Hcl
  • Calcium Citrate
  • Dhea
  • Melatonin
  • Fish Oil
When starting to take Pravastatin the consumer reported the following symptoms:
  • Pain
  • Pain In Extremity
  • Insomnia
  • Product Substitution Issue
  • Product Quality Issue
These side effects may potentially be related to Pravastatin.

Urticaria, Swelling Face
This is a Pravastatin side effect report of a 59-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: blood cholesterol increased, who was treated with Pravastatin (dosage:NA, start time: NS), combined with: NA., and developed a serious reaction and a urticaria side effect. The patient presented with:
  • Urticaria
  • Swelling Face
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Pravastatin treatment in female patients suffering from blood cholesterol increased, resulting in urticaria.

Peripheral Artery Stenosis, Blood Creatine Phosphokinase Increased, Rheumatoid Factor Increased, Musculoskeletal Pain, Joint Stiffness
This report suggests a potential Pravastatin peripheral artery stenosis side effect(s) that can have serious consequences. A 46-year-old male patient from GB (weight:NA) was diagnosed with the following health condition(s): peripheral vascular disorder,blood cholesterol,chronic myeloid leukaemia and used Pravastatin (dosage: NA) starting Aug 05, 2009. Soon after starting Pravastatin the patient began experiencing various side effects, including:
  • Peripheral Artery Stenosis
  • Blood Creatine Phosphokinase Increased
  • Rheumatoid Factor Increased
  • Musculoskeletal Pain
  • Joint Stiffness
Drugs used concurrently:NA. Although Pravastatin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as peripheral artery stenosis, may still occur.

Blood Creatine Phosphokinase Increased, Joint Stiffness, Musculoskeletal Pain, Rheumatoid Factor Increased, Peripheral Artery Stenosis
This blood creatine phosphokinase increased problem was reported by a physician from GB. A 46-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): blood cholesterol,peripheral vascular disorder,chronic myeloid leukaemia.On Aug 05, 2009 a consumer started treatment with Pravastatin (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Pravastatin, the patient experienced the following unwanted symptoms /side effects:
  • Blood Creatine Phosphokinase Increased
  • Joint Stiffness
  • Musculoskeletal Pain
  • Rheumatoid Factor Increased
  • Peripheral Artery Stenosis
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as blood creatine phosphokinase increased, may become evident only after a product is in use by the general population.

Blood Creatine Phosphokinase Increased, Joint Stiffness, Musculoskeletal Pain, Rheumatoid Factor Increased, Peripheral Artery Stenosis
This is a Pravastatin side effect report of a 46-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: blood cholesterol,peripheral vascular disorder,chronic myeloid leukaemia and was treated with Pravastatin (dosage: NA) starting Aug 05, 2009. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Blood Creatine Phosphokinase Increased
  • Joint Stiffness
  • Musculoskeletal Pain
  • Rheumatoid Factor Increased
  • Peripheral Artery Stenosis
This opens a possibility that Pravastatin could cause blood creatine phosphokinase increased and that some male patients may be more susceptible.

Raynaud^s Phenomenon, Erythema
A 78-year-old female patient (weight: NA) from GB with the following symptoms: NA started Pravastatin Sodium treatment (dosage: Started In Hospital) on 201103. Soon after starting Pravastatin Sodium treatment, the consumer experienced several side effects, including:
  • Raynaud^s Phenomenon
  • Erythema
. Concurrently used drugs:
  • Pradaxa (Stopped When Patient In Hospital.)
  • Bisoprolol (Started In Hopsital)
  • Amlodipine (Continuing.)
  • Clopidogrel Bisulfate (Started In Hospital)
This finding indicates that some patients can be more vulnerable to developing Pravastatin Sodium side effects, such as raynaud^s phenomenon.

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 (dosage: NA), which was started on Aug 05, 2009. Concurrently used drugs: NA..When starting to take Pravastatin Sodium the consumer reported symptoms, such as:
  • Peripheral Artery Stenosis
  • Rheumatoid Factor Increased
  • Joint Stiffness
  • Musculoskeletal Pain
  • Blood Creatine Phosphokinase Increased
These side effects may potentially be related to Pravastatin Sodium.

Raynaud^s Phenomenon, Erythema
This is a report of a 78-year-old female patient (weight: NA) from GB, suffering from the following 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). The consumer presented with:
  • Raynaud^s Phenomenon
  • Erythema
which developed 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.

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. Soon after starting Pravastatin the patient began experiencing various side effects, including:
  • Hepatic Failure
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.

Raynaud^s Phenomenon, Erythema
This Raynaud^s Phenomenon, Erythema 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 commencing Pravastatin, the patient experienced the following unwanted symptoms/side effects:
  • Raynaud^s Phenomenon
  • Erythema
Although 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.

Bone Marrow Failure, Petechiae, Oral Pain, Tongue Haemorrhage, Fatigue
This is a report of a 85-year-old female patient (weight: NA) from FI. The patient developed the following symptoms/conditions: NA and was treated with Pravastatin Ratiopharm 40 Mg (dosage: 40 Milligram Daily;) starting 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;)
Soon after that, the consumer experienced the following side effects:
  • Bone Marrow Failure
  • Petechiae
  • Oral Pain
  • Tongue Haemorrhage
  • Fatigue
This opens a possibility that Pravastatin Ratiopharm 40 Mg treatment could cause the above reactions, including bone marrow failure, and some female subjects may be more susceptible.

Nephrolithiasis, Calculus Ureteric, Hypoaesthesia, No Therapeutic Response
A 63-year-old female patient (weight: NA) from US with the following symptoms/conditions: blood cholesterol increased started Pravastatin treatment (dosage: NA) on Dec 21, 2012. Soon after starting Pravastatin treatment, the subject experienced various side effects, including:
  • Nephrolithiasis
  • Calculus Ureteric
  • Hypoaesthesia
  • No Therapeutic Response
Concurrently used drugs:
  • Metoprolol Er Succinate
  • Amlodipine Besylate
  • B-complex
  • Vitc
  • Acetaminophen
This finding indicates that some female patients could be more vulnerable to Pravastatin.

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Top 10 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

Top 10 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

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


    Discuss Pravastatin Side Effects

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    How Effective is Pravastatin for You?

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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