A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Lipitor Side Effects, and Drug Interactions - Atorvastatin
Lipitor Side Effects, and Drug Interactions - Atorvastatin
SIDE EFFECTS
Atorvastatin 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 ³2% of
patients in placebo-controlled clinical studies of atorvastatin, regardless
of causality assessment, are shown in TABLE 6.
| TABLE 6 Adverse Events in Placebo-Controlled
Studies (% of Patients) |
| |
|
Atrovastatin |
| 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
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 assocaited with atorvastatin 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 (see WARNINGS,
Skeletal Muscle).
Antacid: When atorvastatin
and Maalox ä TC suspension
were coadministered, plasma
concentrations of atorvastatin decreased approximately 35%. However, LDL-C
reduction was not altered.
Antipyrine: Because atorvastatin
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
decreased approximately 25% when colestipol and atorvastatin
were coadministered. However, LDL-C reduction
was greater when atorvastatin
and colestipol were coadministered than when either drug
was given alone.
Cimetidine: Atorvastatin plasma
concentrations and LDL-C reduction were not altered by coadministration
of cimetidine.
Digoxin: When multiple
doses of atorvastatin
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
increased approximately 40% with coadministratlon of atorvastatin and
erythromycin, a known inhibitor
of cytochrome P450 3A4
(see WARNINGS, Skeletal Muscle).
Oral Contraceptives: Coadministration of atorvastatin 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.
Warfarin: Atorvastatin had no clinically significant
effect on prothrombin
time when administered to patients
receiving chronic warfarin
treatment.
Other Concomitant Therapy: In clinical
studies, atorvastatin 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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