"The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
HER2 is a protein involved in normal cell growth. It is foun"...
Arimidex Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Arimidex (anastrozole) is used to treat breast cancer in postmenopausal women. It is often given to women whose cancer has progressed even after taking tamoxifen (Nolvadex, Soltamox). It is a non-steroidal aromatase inhibitor. This medication is available in generic form. Common side effects include constipation, diarrhea, nausea, vomiting, upset stomach, loss of appetite, body aches and pains, breast swelling/tenderness/pain, headache, dry mouth, scratchy throat, increased cough, dizziness, trouble sleeping, tiredness/weakness, flushing and sweating (hot flashes/hot flushes), vaginal bleeding, hair thinning, and weight change.
The dose of Arimidex is one 1 mg tablet taken once a day. For patients with advanced breast cancer, the medication should be continued until tumor progression. Arimidex may not work as well if taken with tamoxifen or an estrogen medication. Other drugs may interact with Arimidex. Tell your doctor all prescription and over-the-counter medications and supplements you use. Arimidex is used mainly in women after menopause. This medication must not be used during pregnancy. It may cause harm to a fetus or miscarriage. Products containing estrogen (such as birth control pills) should not be used. Consult your doctor about birth control. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended.
Our Arimidex (anastrozole) 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.
Arimidex 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.
Call your doctor at once if you have a serious side effect such as:
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- a bone fracture;
- swollen glands;
- feeling short of breath;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- swelling in your hands or feet; or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- numbness, tingling, cold feeling, or weakness in your hand or wrist;
- problems with your fingers while gripping;
- hot flashes;
- joint pain or stiffness;
- depression, mood changes, sleep problems (insomnia);
- cough, sore throat;
- thinning hair;
- mild nausea, vomiting; or
- back pain, bone pain.
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.
Read the entire detailed patient monograph for Arimidex (Anastrozole)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Arimidex Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression), excessive thirst, numbness/tingling/swelling of the hands or feet, persistent cough, unusual vaginal discharge/burning/itching/odor, unusually stiff muscles, muscle pain, pain/redness/swelling of the arms or legs, vision changes, bone pain, bone fracture, signs of infection (e.g., fever, chills, persistent sore throat).
Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, jaw/left arm pain, trouble breathing, confusion, fainting, slurred speech, weakness on one side of the body.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 Arimidex (Anastrozole)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Arimidex FDA Prescribing Information: Side Effects
Serious adverse reactions with ARIMIDEX occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face, lips, tongue, and/or throat. This may cause difficulty in swallowing and/or breathing; and 3) changes in blood tests of the liver function, including inflammation of the liver with symptoms that may include a general feeling of not being well, with or without jaundice, liver pain or liver swelling.
Common adverse reactions (occurring with an incidence of ≥ 10%) in women taking ARIMIDEX included: hot flashes, asthenia, arthritis, pain, arthralgia, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, bone pain, peripheral edema, increased cough, dyspnea, pharyngitis and lymphedema.
In the ATAC trial, the most common reported adverse reaction ( > 0.1%) leading to discontinuation of therapy for both treatment groups was hot flashes, although there were fewer patients who discontinued therapy as a result of hot flashes in the ARIMIDEX group.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trials Experience
Adverse reaction data for adjuvant therapy are based on the ATAC trial [see Clinical Studies]. The median duration of adjuvant treatment for safety evaluation was 59.8 months and 59.6 months for patients receiving ARIMIDEX 1 mg and tamoxifen 20 mg, respectively.
Adverse reactions occurring with an incidence of at least 5% in either treatment group during treatment or within 14 days of the end of treatment are presented in Table 1.
Table 1 :Adverse reactions occurring with an incidence
of at least 5% in either treatment group during treatment, or within 14 days of
the end of treatment in the ATAC trial*
|Body system and adverse reactions by COSTART preferred term*||ARIMIDEX 1 mg
(N§ = 3092)
|Tamoxifen 20 mg
(N§ = 3094)
|Body as a whole|
|Asthenia||575 (19)||544 (18)|
|Back pain||321 (10)||309 (10)|
|Headache||314 (10)||249 (8)|
|Abdominal pain||271 (9)||276 (9)|
|Infection||285 (9)||276 (9)|
|Accidental injury||311 (10)||303 (10)|
|Flu syndrome||175 (6)||195 (6)|
|Chest pain||200 (7)||150 (5)|
|Neoplasm||162 (5)||144 (5)|
|Cyst||138 (5)||162 (5)|
|Vasodilatation||1104 (36)||1264 (41)|
|Hypertension||402 (13)||349 (11)|
|Nausea||343 (11)||335 (11)|
|Constipation||249 (8)||252 (8)|
|Diarrhea||265 (9)||216 (7)|
|Dyspepsia||206 (7)||169 (6)|
|Gastrointestinal disorder||210 (7)||158 (5)|
|Hemic and lymphatic|
|Lymphedema||304 (10)||341 (11)|
|Anemia||113 (4)||159 (5)|
|Metabolic and nutritional|
|Peripheral edema||311 (10)||343 (11)|
|Weight gain||285 (9)||274 (9)|
|Hypercholesterolemia||278 (9)||108 (3.5)|
|Arthritis||512 (17)||445 (14)|
|Arthralgia||467 (15)||344 (11)|
|Osteoporosis||325 (11)||226 (7)|
|Bone pain||201 (7)||185 (6)|
|Arthrosis||207 (7)||156 (5)|
|Joint Disorder||184 (6)||160 (5)|
|Myalgia||179 (6)||160 (5)|
|Depression||413 (13)||382 (12)|
|Insomnia||309 (10)||281 (9)|
|Dizziness||236 (8)||234 (8)|
|Anxiety||195 (6)||180 (6)|
|Paresthesia||215 (7)||145 (5)|
|Pharyngitis||443 (14)||422 (14)|
|Cough increased||261 (8)||287 (9)|
|Dyspnea||234 (8)||237 (8)|
|Sinusitis||184 (6)||159 (5)|
|Bronchitis||167 (5)||153 (5)|
|Skin and appendages|
|Rash||333 (11)||387 (13)|
|Sweating||145 (5)||177 (6)|
|Cataract Specified||182 (6)||213 (7)|
|Leukorrhea||86 (3)||286 (9)|
|Urinary tract infection||244 (8)||313(10)|
|Breast pain||251 (8)||169 (6)|
|Breast Neoplasm||164 (5)||139 (5)|
|Vulvovaginitis||194 (6)||150 (5)|
|Vaginal Hemorrhage¶||122 (4)||180 (6)|
|Vaginitis||125 (4)||158 (5)|
|* The combination arm was discontinued due to lack of
efficacy benefit at 33 months of follow-up.
†COSTART Coding Symbols for Thesaurus of Adverse Reaction Terms.
‡ A patient may have had more than 1 adverse reaction, including more than 1 adverse reaction in the same body system.
§ N=Number of patients receiving the treatment.
¶Vaginal Hemorrhage without further diagnosis.
Certain adverse reactions and combinations of adverse reactions were prospectively specified for analysis, based on the known pharmacologic properties and side effect profiles of the two drugs (see Table 2).
Table 2 : Number of Patients
with Pre-specified Adverse Reactions in ATAC Trial*
|Hot Flashes||1104 (36)||1264 (41)||0.80||0.73 -0.89|
|Musculoskeletal Events'1||1100 (36)||911 (29)||1.32||1.19 -1.47|
|Fatigue/Asthenia||575 (19)||544 (18)||1.07||0.94 -1.22|
|Mood Disturbances||597 (19)||554 (18)||1.10||0.97 - 1.25|
|Nausea and Vomiting||393 (13)||384 (12)||1.03||0.88 -1.19|
|All Fractures||315 (10)||209 (7)||1.57||1.30 -1.88|
|Fractures of Spine, Hip, or Wrist||133 (4)||91 (3)||1.48||1.13 -1.95|
|Wrist/Colles’ fractures||67 (2)||50 (2)|
|Spine fractures||43 (1)||22 (1)|
|Hip fractures||28 (1)||26 (1)|
|Cataracts||182 (6)||213 (7)||0.85||0.69 -1.04|
|Vaginal Bleeding||167 (5)||317(10)||0.50||0.41 -0.61|
|Ischemic Cardiovascular Disease||127 (4)||104 (3)||1.23||0.95 -1.60|
|Vaginal Discharge||109 (4)||408 (13)||0.24||0.19 -0.30|
|Venous Thromboembolic events||87 (3)||140 (5)||0.61||0.47 -0.80|
|Deep Venous Thromboembolic Events||48 (2)||74 (2)||0.64||0.45 -0.93|
|Ischemic Cerebrovascular Event||62 (2)||88 (3)||0.70||0.50 -0.97|
|Endometrial Cancer*||4 (0.2)||13 (0.6)||0.31||0.10 -0.94|
|* Patients with multiple events in the same category are
counted only once in that category.
†Refers to joint symptoms, including joint disorder, arthritis, arthrosis and arthralgia.
‡ Percentages calculated based upon the numbers of patients with an intact uterus at baseline
Ischemic Cardiovascular Events
Between treatment arms in the overall population of 6186 patients, there was no statistical difference in ischemic cardiovascular events (4% ARIMIDEX vs. 3% tamoxifen).
In the overall population, angina pectoris was reported in 71/3092 (2.3%) patients in the ARIMIDEX arm and 51/3094 (1.6%) patients in the tamoxifen arm; myocardial infarction was reported in 37/3092 (1.2%) patients in the ARIMIDEX arm and 34/3094 (1.1%) patients in the tamoxifen arm.
In women with pre-existing ischemic heart disease 465/6186 (7.5%), the incidence of ischemic cardiovascular events was 17% in patients on ARIMIDEX and 10% in patients on tamoxifen. In this patient population, angina pectoris was reported in 25/216 (11.6%) patients receiving ARIMIDEX and 13/249 (5.2%) patients receiving tamoxifen; myocardial infarction was reported in 2/216 (0.9%) patients receiving ARIMIDEX and 8/249 (3.2%) patients receiving tamoxifen.
Bone Mineral Density Findings
Results from the ATAC trial bone substudy at 12 and 24 months demonstrated that patients receiving ARIMIDEX had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline.
Because ARIMIDEX lowers circulating estrogen levels it may cause a reduction in bone mineral density.
A post-marketing trial assessed the combined effects of ARIMIDEX and the bisphosphonate risedronate on changes from baseline in BMD and markers of bone resorption and formation in postmenopausal women with hormone receptor-positive early breast cancer. All patients received calcium and vitamin D supplementation. At 12 months, small reductions in lumbar spine bone mineral density were noted in patients not receiving bisphosphonates. Bisphosphonate treatment preserved bone density in most patients at risk of fracture.
Postmenopausal women with early breast cancer scheduled to be treated with ARIMIDEX should have their bone status managed according to treatment guidelines already available for postmenopausal women at similar risk of fragility fracture.
During the ATAC trial, more patients receiving ARIMIDEX were reported to have an elevated serum cholesterol compared to patients receiving tamoxifen (9% versus 3.5%, respectively).
A post-marketing trial also evaluated any potential effects of ARIMIDEX on lipid profile. In the primary analysis population for lipids (ARIMIDEX alone), there was no clinically significant change in LDL-C from baseline to 12 months and HDL-C from baseline to 12 months.
In secondary population for lipids (ARIMIDEX+risedronate), there also was no clinically significant change in LDL-C and HDL-C from baseline to 12 months.
In both populations for lipids, there was no clinically significant difference in total cholesterol (TC) or serum triglycerides (TG) at 12 months compared with baseline.
In this trial, treatment for 12 months with ARIMIDEX alone had a neutral effect on lipid profile. Combination treatment with ARIMIDEX and risedronate also had a neutral effect on lipid profile.
The trial provides evidence that postmenopausal women with early breast cancer scheduled to be treated with ARIMIDEX should be managed using the current National Cholesterol Education Program guidelines for cardiovascular risk-based management of individual patients with LDL elevations.
Other Adverse Reactions
Patients receiving ARIMIDEX had an increase in joint disorders (including arthritis, arthrosis and arthralgia) compared with patients receiving tamoxifen. Patients receiving ARIMIDEX had an increase in the incidence of all fractures (specifically fractures of spine, hip and wrist) [315 (10%)] compared with patients receiving tamoxifen [209 (7%)].
Patients receiving ARIMIDEX had a higher incidence of carpal tunnel syndrome [78 (2.5%)] compared with patients receiving tamoxifen [22 (0.7%)].
Vaginal bleeding occurred more frequently in the tamoxifen-treated patients versus the ARIMIDEX-treated patients 317 (10%) versus 167 (5%), respectively.
Patients receiving ARIMIDEX had a lower incidence of hot flashes, vaginal bleeding, vaginal discharge, endometrial cancer, venous thromboembolic events and ischemic cerebrovascular events compared with patients receiving tamoxifen.
10-Year Median Follow-Up Safety Results From The ATAC Trial
Results are consistent with the previous analyses.
Serious adverse reactions were similar between ARIMIDEX (50%) and tamoxifen (51%).
- Cardiovascular events were consistent with the known safety profiles of ARIMIDEX and tamoxifen.
- The cumulative incidences of all first fractures (both serious and non-serious, occurring either during or after treatment) was higher in the ARIMIDEX group (15%) compared to the tamoxifen group (11%). This increased first fracture rate during treatment did not continue in the post-treatment follow-up period.
- The cumulative incidence of new primary cancers was similar in the ARIMIDEX group (13.7%) compared to the tamoxifen group (13.9%). Consistent with the previous analyses, endometrial cancer was higher in the tamoxifen group (0.8%) compared to the ARIMIDEX group (0.2%).
- The overall number of deaths (during or off-trial treatment) was similar between the treatment groups. There were more deaths related to breast cancer in the tamoxifen than in the ARIMIDEX treatment group.
Adverse reactions occurring with an incidence of at least 5% in either treatment group of trials 0030 and 0027 during or within 2 weeks of the end of treatment are shown in Table 3.
Table 3 : Adverse Reactions Occurring with an
Incidence of at Least 5% in Trials 0030 and 0027
|Number (%) of subjects|
|ARIMIDEX (N=506)||Tamoxifen (N=511)|
|Back pain||60(12)||68 (13)|
|Headache||47 (9)||40 (8)|
|Abdominal pain||40 (8)||38 (7)|
|Chest pain||37 (7)||37 (7)|
|Flu syndrome||35 (7)||30 (6)|
|Pelvic pain||23 (5)||30 (6)|
|Vasodilation||128 (25)||106 (21)|
|Hypertension||25 (5)||36 (7)|
|Nausea||94 (19)||106 (21)|
|Constipation||47 (9)||66 (13)|
|Diarrhea||40 (8)||33 (6)|
|Vomiting||38 (8)||36 (7)|
|Anorexia||26 (5)||46 (9)|
|Metabolic and Nutritional|
|Peripheral edema||51 (10)||41 (8)|
|Bone pain||54 (11)||52 (10)|
|Dizziness||30 (6)||22 (4)|
|Insomnia||30 (6)||38 (7)|
|Depression||23 (5)||32 (6)|
|Hypertonia||16 (3)||26 (5)|
|Cough increased||55 (11)||52 (10)|
|Dyspnea||51 (10)||47 (9)|
|Pharyngitis||49 (10)||68 (13)|
|Skin and appendages|
|Rash||38 (8)||34 (8)|
|Leukorrhea||9 (2)||31 (6)|
|* A patient may have had more than 1 adverse event.|
Less frequent adverse experiences reported in patients receiving ARIMIDEX l mg in either Trial 0030 or Trial 0027 were similar to those reported for second-line therapy.
Based on results from second-line therapy and the established safety profile of tamoxifen, the incidences of 9 pre-specified adverse event categories potentially causally related to one or both of the therapies because of their pharmacology were statistically analyzed. No significant differences were seen between treatment groups.
Table 4 : Number of Patients
with Pre-specified Adverse Reactions in Trials 0030 and 0027
|Adverse Reaction*||Number (n) and Percentage of Patients|
|ARIMIDEX 1 mg
|NOLVADEX 20 mg
|Depression||23 (5)||32 (6)|
|Tumor Flare||15 (3)||18 (4)|
|Thromboembolic Disease†||18 (4)||33 (6)|
|Coronary and Cerebral‡||13||19|
|Gastrointestinal Disturbance||170 (34)||196 (38)|
|Hot Flushes||134 (26)||118 (23)|
|Vaginal Dryness||9 (2)||3 (1)|
|Lethargy||6 (1)||15 (3)|
|Vaginal Bleeding||5 (1)||11 (2)|
|Weight Gain||11 (2)||8 (2)|
|* A patient may have had more
than 1 adverse reaction.
†Includes pulmonary embolus, thrombophlebitis, retinal vein thrombosis.
‡ Includes myocardial infarction, myocardial ischemia, angina pectoris, cerebrovascular accident, cerebral ischemia and cerebral infarct.
ARIMIDEX was tolerated in two controlled clinical trials (i.e., Trials 0004 and 0005), with less than 3.3% of the ARIMIDEX-treated patients and 4.0% of the megestrol acetate-treated patients withdrawing due to an adverse reaction.
The principal adverse reaction more common with ARIMIDEX than megestrol acetate was diarrhea. Adverse reactions reported in greater than 5% of the patients in any of the treatment groups in these two controlled clinical trials, regardless of causality, are presented below:
Table 5 :Number (N) and Percentage of Patients with
Adverse Reactions in Trials 0004 and 0005
|Adverse Reaction*||ARIMIDEX 1 mg
|ARIMIDEX 10 mg
|Megestrol Acetate 160 mg
|* A patient may have had more than one adverse reaction. Other less frequent (2% to 5%) adverse reactions reported in patients receiving ARIMIDEX l mg in either Trial 0004 or Trial 0005 are listed below. These adverse experiences are listed by body system and are in order of decreasing frequency within each body system regardless of assessed causality.|
Body as a Whole: Flu syndrome; fever; neck pain; malaise; accidental injury; infection
Cardiovascular: Hypertension; thrombophlebitis
Metabolic and Nutritional: Alkaline phosphatase increased; weight loss
Mean serum total cholesterol levels increased by 0.5 mmol/L among patients receiving ARIMIDEX. Increases in LDL cholesterol have been shown to contribute to these changes.
Musculoskeletal: Myalgia; arthralgia; pathological fracture
Nervous: Somnolence; confusion; insomnia; anxiety; nervousness
The incidences of the following adverse reaction groups potentially causally related to one or both of the therapies because of their pharmacology, were statistically analyzed: weight gain, edema, thromboembolic disease, gastrointestinal disturbance, hot flushes, and vaginal dryness. These six groups, and the adverse reactions captured in the groups, were prospectively defined. The results are shown in the table below.
Table 6 : Number (n) and Percentage of Patients with
Pre-specified Adverse Reactions in Trials 0004 and 0005
|Adverse Reaction Group||ARIMIDEX1 mg
|Megestrol Acetate160 mg
These adverse reactions are reported voluntarily from a population of uncertain size. Therefore, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. The following have been reported in post-approval use of Arimidex:
- Hepatobiliary events including increases in alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-GT, and bilirubin; hepatitis
- Rash including cases of mucocutaneous disorders such as erythema multiforme and Stevens-Johnson syndrome
- Cases of allergic reactions including angioedema, urticaria and anaphylaxis [see CONTRAINDICATIONS]
- Myalgia, trigger finger and hypercalcemia (with or without an increase in parathyroid hormone)
Read the entire FDA prescribing information for Arimidex (Anastrozole)
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