"What are statins and how do they work?
Statins (or HMG-CoA reductase inhibitors) are a class of drugs that reduce cholesterol in individuals who have dyslipidemia (abnormal fats in the blood) and thus are at risk for cardiovascular dise"...
Pravachol Side Effects Center
Pharmacy Editor: Eni Williams, Pharm.D., Ph.D.
Pravachol (pravastatin) is a medication belonging to the drug class known as HMG-CoA reductase inhibitors, also called "statins." It is available as a generic. Pravachol (pravastatin) is used to lower blood cholesterol and reduce the risk of heart attack, stroke and death due to arteriosclerotic vascular disease. Some common side effects of Pravachol (pravastatin) include headache, nausea, vomiting, diarrhea, muscle pain, and abnormal liver tests.
The usual dose of Pravachol (pravastatin) ranges from 10 mg to 80 mg daily. Drug interactions include cholestyramine, nicotinic acid, gemfibrozil, cholchicine and cyclosporine. Pravachol (pravastatin) should not be used during pregnancy. Breastfeeding mothers also should not use this drug because of the potential risk to nursing infants.
Our Pravachol (pravastatin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Pravachol in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking pravastatin and call your doctor at once if you have any of these serious side effects:
- unexplained muscle pain, tenderness, or weakness;
- confusion, memory problems;
- fever, unusual tiredness, and dark colored urine;
- chest pain;
- increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
- swelling, weight gain, urinating less than usual or not at all; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- mild muscle pain;
- mild skin rash; or
Read the entire detailed patient monograph for Pravachol (Pravastatin Sodium) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Pravachol Overview - Patient Information: Side Effects
A very small number of people taking pravastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.
This drug may infrequently cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms persist after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.
This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor immediately: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Pravachol (Pravastatin Sodium)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Pravachol FDA Prescribing Information: Side Effects
Pravastatin is generally well tolerated; adverse reactions have usually been mild and transient. In 4-month-long placebo-controlled trials, 1.7% of pravastatin-treated patients and 1.2% of placebo-treated patients were discontinued from treatment because of adverse experiences attributed to study drug therapy; this difference was not statistically significant.
Adverse Clinical Events
Short-Term Controlled Trials
In the PRAVACHOL placebo-controlled clinical trials database of 1313 patients (age range 20-76 years, 32.4% women, 93.5% Caucasians, 5% Blacks, 0.9% Hispanics, 0.4% Asians, 0.2% Others) with a median treatment duration of 14 weeks, 3.3% of patients on PRAVACHOL and 1.2% patients on placebo discontinued due to adverse events regardless of causality. The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: liver function test increased, nausea, anxiety/depression, and dizziness.
All adverse clinical events (regardless of causality) reported in ≥ 2% of pravastatin-treated patients in placebo-controlled trials of up to 8 months duration are identified in Table 1:
Table 1: Adverse Events in ≥ 2% of Patients
Treated with Pravastatin 5 to 40 mg and at an Incidence Greater Than Placebo in
Short-Term Placebo-Controlled Trials (% of patients)
|Body System/Event||5 mg
|Upper Respiratory Infection||6.0||9.8||5.2||4.1||5.9||5.8|
The safety and tolerability of PRAVACHOL at a dose of 80 mg in 2 controlled trials with a mean exposure of 8.6 months was similar to that of PRAVACHOL at lower doses except that 4 out of 464 patients taking 80 mg of pravastatin had a single elevation of CK > 10 times ULN compared to 0 out of 115 patients taking 40 mg of pravastatin.
Long-Term Controlled Morbidity and Mortality Trials
In the PRAVACHOL placebo-controlled clinical trials database of 21,483 patients (age range 24-75 years, 10.3% women, 52.3% Caucasians, 0.8% Blacks, 0.5% Hispanics, 0.1% Asians, 0.1% Others, 46.1% Not Recorded) with a median treatment duration of 261 weeks, 8.1% of patients on PRAVACHOL and 9.3% patients on placebo discontinued due to adverse events regardless of causality.
Adverse event data were pooled from 7 double-blind, placebo-controlled trials (West of Scotland Coronary Prevention Study [WOS]; Cholesterol and Recurrent Events study [CARE]; Long-term Intervention with Pravastatin in Ischemic Disease study [LIPID]; Pravastatin Limitation of Atherosclerosis in the Coronary Arteries study [PLAC I]; Pravastatin, Lipids and Atherosclerosis in the Carotids study [PLAC II]; Regression Growth Evaluation Statin Study [REGRESS]; and Kuopio Atherosclerosis Prevention Study [KAPS]) involving a total of 10,764 patients treated with pravastatin 40 mg and 10,719 patients treated with placebo. The safety and tolerability profile in the pravastatin group was comparable to that of the placebo group. Patients were exposed to pravastatin for a mean of 4.0 to 5.1 years in WOS, CARE, and LIPID and 1.9 to 2.9 years in PLAC I, PLAC II, KAPS, and REGRESS. In these long-term trials, the most common reasons for discontinuation were mild, non-specific gastrointestinal complaints. Collectively, these 7 trials represent 47,613 patient-years of exposure to pravastatin. All clinical adverse events (regardless of causality) occurring in ≥ 2% of patients treated with pravastatin in these studies are identified in Table 2.
Table 2: Adverse Events in ≥ 2% of Patients Treated
with Pravastatin 40 mg and at an Incidence Greater Than Placebo in Long-Term
% of patients
% of patients
|Rash (including dermatitis)||7.2||7.1|
|Renal/Genitourinary Urinary Tract Infection||2.7||2.6|
|Upper Respiratory Tract Infection||21.2||20.2|
|Vision Disturbance (includes blurred vision, diplopia)||3.4||3.3|
In addition to the events listed above in the long-term trials table, events of probable, possible, or uncertain relationship to study drug that occurred in < 2.0% of pravastatin-treated patients in the long-term trials included the following:
Dermatologic: scalp hair abnormality (including alopecia), urticaria.
Endocrine/Metabolic: sexual dysfunction, libido change.
Immunologic: allergy, edema head/neck.
Musculoskeletal: muscle weakness.
Nervous System: vertigo, insomnia, memory impairment, neuropathy (including peripheral neuropathy).
Special Senses: taste disturbance.
In addition to the events reported above, as with other drugs in this class, the following events have been reported rarely during postmarketing experience with PRAVACHOL, regardless of causality assessment:
Musculoskeletal: myopathy, rhabdomyolysis.
Nervous System: dysfunction of certain cranial nerves (including alteration of taste, impairment of extraocular movement, facial paresis), peripheral nerve palsy.
There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Hypersensitivity: anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, hemolytic anemia, positive ANA, ESR increase, arthritis, arthralgia, asthenia, photosensitivity, chills, malaise, toxic epidermal necrolysis, erythema multiforme (including Stevens-Johnson syndrome).
Gastrointestinal: abdominal pain, constipation, pancreatitis, hepatitis (including chronic active hepatitis), cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, hepatoma, fatal and non-fatal hepatic failure.
Dermatologic: a variety of skin changes (e.g., nodules, discoloration, dryness of mucous membranes, changes to hair/nails).
Renal: urinary abnormality (including dysuria, frequency, nocturia).
Laboratory Abnormalities: liver function test abnormalities, thyroid function abnormalities.
Laboratory Test Abnormalities
Increases in ALT, AST values and CPK have been observed [see WARNINGS AND PRECAUTIONS].
Transient, asymptomatic eosinophilia has been reported. Eosinophil counts usually returned to normal despite continued therapy. Anemia, thrombocytopenia, and leukopenia have been reported with statins.
In a 2-year, double-blind, placebo-controlled study involving 100 boys and 114 girls with HeFH (n=214; age range 8-18.5 years, 53% female, 95% Caucasians, < 1% Blacks, 3% Asians, 1% Other), the safety and tolerability profile of pravastatin was generally similar to that of placebo. [See WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY.]
Read the entire FDA prescribing information for Pravachol (Pravastatin Sodium) »
Additional Pravachol Information
Pravachol - User Reviews
Pravachol User Reviews
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