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Heart Disease 

Generic Drugs

Lipitor Side Effects

From Pfizer


Atorvastatin (Lipitor) is generally well-tolerated. Adverse reactions have usually been mild and transient. In controlled clinical studies of 2502 patients, <2% of patients were discontinued due to adverse experiences attributable to Atorvastatin (Lipitor). The most frequent adverse events thought to be related to Atorvastatin (Lipitor) were constipation, flatulence, dyspepsia, and abdominal pain.

Clinical Adverse Experiences

Adverse experiences reported in more than or equal to 2% of patients in placebo-controlled clinical studies of Atorvastatin (Lipitor), regardless of causality assessment, are shown in TABLE 6.

TABLE 6 Adverse Events in Placebo-Controlled Studies (% of Patients)
Body System/ Placebo 10 mg 20 mg 40 mg 80 mg
Adverse Event N=270 N=863 N=36 N=79 N=94
 Body as a Whole
    Infection 10.0 10.3 2.8 10.1 7.4
    Headache 7.0 5.4 16.7 2.5 6.4
    Accidental Injury 3.7 4.2 0.0 1.3 3.2
    Flu Syndrome 1.9 2.2 0.0 2.5 3.2
    Abdominal Pain 0.7 2.8 0.0 3.8 2.1
    Back Pain 3.0 2.8 0.0 3.8 1.1
    Allergic Reaction 2.6 0.9 2.8 1.3 0.0
    Asthenia 1.9 2.2 0.0 3.8 0.0
 Digestive System
    Constipation 1.8 2.1 0.0 2.5 1.1
    Diarrhea 1.5 2.7 0.0 3.8 5.3
    Dyspepsia 4.1 2.3 2.8 1.3 2.1
    Flatulence 3.3 2.1 2.8 1.3 1.1
 Respiratory System
    Sinusitis 2.6 2.8 0.0 2.5 6.4
    Pharyngitis 1.5 2.5 0.0 1.3 2.1
 Skin And Appendages
    Rash 0.7 3.9 2.8 3.8 1.1
 Musculoskeletal System
    Arthralgia 1.5 2.0 0.0 5.1 0.0
    Myalgia 1.1 3.2 5.6 1.3 0.0

The following adverse events were reported, regardless of causality assessment in patients treated with Atorvastatin (Lipitor) in clinical trials. The events in italics occurred in >2% of patients and the events in plain type occurred in <2% of patients.

Body as a Whole: Chest pain, face edema, fever, neck rigidity, malaise, photosensitivity reaction, generalized edema.

Digestive System: Nausea, gastroenteritis, liver function tests abnormal, colitis, vomiting, gastritis, dry mouth, rectal hemorrhage, esophagitis. eructation, glossitis, mouth ulceration, anorexia, increased appetite, stomatitis, biliary pain, cheilitis, duodenal ulcer, dysphagia, enteritis, melena, gum hemorrhage, stomach ulcer, tenesmus, ulcerative stomatitis, hepatitis, pancreatitis, cholestatic jaundice.

Respiratory System: Bronchitis, rhinitis, pneumonia, dyspnea, asthma, epistaxis.

Nervous System: Insomnia, dizziness, paresthesia, somnolence, amnesia, abnormal dreams, libido decreased, emotional lability, incoordination, peripheral neuropathy, torticollis, facial paralysis, hyperkinesia, depression, hypesthesis, hypertonia.

Musculoskeletal System: Arthritis, leg cramps, bursitis, tenosynovitis, myasthenia, tendinous contracture, myositis.

Skin and Appendages: Pruritus, contact dermatitis, alopecia, dry skin, sweating, acne, urticaria, eczema, seborrhea, skin ulcer.

Urogenital System: Urinary tract infection, urinary frequency, cystitis, hematuria, impotence, dysuria, kidney calculus, nocturia, epididymitis, fibrocystic breast, vaginal hemorrhage, albuminuria, breast enlargement, metrorrhagia, nephritis, urinary incontinence, urinary retention, urinary urgency, abnormal ejaculation, uterine hemorrhage.

Special Senses: Amblyopia, tinnitus, dry eyes, refraction disorder, eye hemorrhage, deafness, glaucoma, parosmia, taste loss, taste perversion.

Cardiovascular System: Palpitation, vasodilatation, syncope, migraine, postural hypotension, phlebitis, arrhythmia, angina pectoris, hypertension.

Metabolic and Nutrtional Disorders: Peripheral edema, hyperglycemia, creatine phosphokinase increased, gout, weight gain, hypoglycemia.

Hemic and Lymphatic System: Ecchymosis, anemia, lymphadenopathy, thrombocytopenia, petechia.

Post Introduction Reports

Adverse events associated with Atorvastatin (Lipitor) that have been received since market introduction, that are not listed above, and that may have causal relationship to drug include the following: angioneurotic edema and rhabdomyolysis.


The risk of myopathy during treatment with other drugs of this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, azole antifungals.

Antacid: When Atorvastatin (Lipitor) and Maalox ?TC suspension were coadministered, plasma concentrations of Atorvastatin (Lipitor) decreased approximately 35%. However, LDL-C reduction was not altered.

Antipyrine: Because Atorvastatin (Lipitor) does not affect the pharmacokinetics of antipyrine, interactions with other drugs metabolized via the same cytochrome isozymes are not expected.

Colestipol: Plasma concentrations of Atorvastatin (Lipitor) decreased approximately 25% when colestipol and Atorvastatin (Lipitor) were coadministered. However, LDL-C reduction was greater when Atorvastatin (Lipitor) and colestipol were coadministered than when either drug was given alone.

Cimetidine: Atorvastatin (Lipitor) plasma concentrations and LDL-C reduction were not altered by coadministration of cimetidine.

Digoxin: When multiple doses of Atorvastatin (Lipitor) and digoxin were coadministered, steady-state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately.

Erythromycin: In healthy individuals, plasma concentrations of Atorvastatin (Lipitor) increased approximately 40% with coadministratlon of Atorvastatin (Lipitor) and erythromycin, a known inhibitor of cytochrome P450 3A4.

Oral Contraceptives: Coadministration of Atorvastatin (Lipitor) and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol by approximately 30% and 20%. These increases should be considered when selecting an oral contraceptive for a woman taking Atorvastatin (Lipitor).

Warfarin: Atorvastatin (Lipitor) had no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin treatment.

Other Concomitant Therapy: In clinical studies, Atorvastatin (Lipitor) was used concomitantly with antihypertensive agents and estrogen replacement therapy without evidence of clinically significant adverse interactions. Interaction studies with specific agents have not been conducted.


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