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Generic Drugs Lipitor Side
Effects
From Pfizer
LIPITOR SIDE EFFECTS
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) |
| |
|
Atovastatin |
| 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.
DRUG INTERACTIONS
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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