ADVERSE REACTIONS
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. The most frequent adverse events thought to be related to atorvastatin were constipation, flatulence, dyspepsia, and abdominal pain.
CLINICAL ADVERSE EXPERIENCES
Adverse experiences reported in >/=2% of patients in placebo-controlled clinical studies of atorvastatin, regardless of causality assessment, are shown in Table 7.
TABLE 7. Adverse Events in Placebo-Controlled Studies
(% of Patients)
BODY SYSTEM/
Adverse Event
|
Placebo
N = 270
|
Atorvastatin
10 mg
N = 863
|
Atorvastatin
20 mg
N = 36
|
Atorvastatin
40 mg
N = 79
|
Atorvastatin
80 mg
N = 94
|
| BODY AS A WHOLE |
|
Infection
Headache
Accidental Injury
Flu Syndrome
Abdominal Pain
Back Pain
Allergic Reaction
Asthenia
|
10.0
7.0
3.7
1.9
0.7
3.0
2.6
1.9
|
10.3
5.4
4.2
2.2
2.8
2.8
0.9
2.2
|
2.8
16.7
0.0
0.0
0.0
0.0
2.8
0.0
|
10.1
2.5
1.3
2.5
3.8
3.8
1.3
3.8
|
7.4
6.4
3.2
3.2
2.1
1.1
0.0
0.0
|
| DIGESTIVE SYSTEM |
|
Constipation
Diarrhea
Dyspepsia
Flatulence
|
1.8
1.5
4.1
3.3
|
2.1
2.7
2.3
2.1
|
0.0
0.0
2.8
2.8
|
2.5
3.8
1.3
1.3
|
1.1
5.3
2.1
1.1
|
| RESPIRATORY SYSTEM |
|
Sinusitis
Pharyngitis
|
2.6
1.5
|
2.8
2.5
|
0.0
0.0
|
2.5
1.3
|
6.4
2.1
|
| SKIN AND APPENDAGES |
|
Rash
|
0.7
|
3.9
|
2.8
|
3.8
|
1.1
|
| MUSCULOSKELETAL SYSTEM |
|
Arthralgia
Myalgia
|
1.5
1.1
|
2.0
3.2
|
0.0
5.6
|
5.1
1.3
|
0.0
0.0
|
|
Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT)
In ASCOT (see CLINICAL PHARMACOLOGY, Clinical Studies) involving 10,305 participants treated with Lipitor 10 mg daily (n=5,168) or placebo (n=5,137), the safety and tolerability profile of the group treated with Lipitor was comparable to that of the group treated with placebo during a median of 3.3 years of follow-up.
The following adverse events were reported, regardless of causality assessment in patients treated with atorvastatin 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, hypesthesia, 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 Nutritional Disorders: Peripheral edema, hyperglycemia, creatine phosphokinase increased, gout, weight gain, hypoglycemia.
Hemic and Lymphatic System: Ecchymosis, anemia, lymphadenopathy, thrombocytopenia, petechia.
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