Arimidex vs Tamoxifen: The ATAC Trial and FDA Labels
[Breast cancer · Hormone therapy · Comparison]

Arimidex vs tamoxifen: how do the two breast cancer tablets differ?

Approved uses · Dose · ATAC side effects · Warnings

Short answer: Both treat hormone receptor-positive breast cancer.12 Arimidex, an aromatase inhibitor, is approved only for postmenopausal women; tamoxifen, an antiestrogen, also covers metastatic disease in men, DCIS and risk reduction in high-risk women. In ATAC, reported in the Arimidex label, fractures and joint symptoms were more common on Arimidex, and hot flashes, vaginal bleeding and blood clots on tamoxifen. Only tamoxifen has a boxed warning.

How do Arimidex and tamoxifen compare side by side?

From the US Arimidex label and the generic tamoxifen citrate label (Mylan). The side-effect rows come from ATAC, which compared the two directly in postmenopausal women after surgery for early breast cancer.
ArimidexTamoxifen
Approved forPostmenopausal women: after surgery for hormone receptor-positive early breast cancer, first treatment of advanced breast cancer, and advanced disease that progressed after tamoxifen1Metastatic breast cancer in women and men, treatment after surgery, lowering invasive cancer risk after DCIS, and lowering breast cancer incidence in high-risk women2
Label dose1 mg once a day, with or without food120 to 40 mg daily for breast cancer, doses above 20 mg split morning and evening; 20 mg daily for 5 years for DCIS and risk reduction2
How longAfter surgery: best length unknown, 5 years in ATAC; advanced cancer: until it progresses1Trial data support 5 years after surgery2
ATAC: hot flashes36%141%1
ATAC: joint symptoms36%129%1
ATAC: all fractures10%17%1
ATAC: vaginal bleeding / discharge5% / 4%110% / 13%1
ATAC: venous blood clots / endometrial cancer3% / 0.2%15% / 0.6%1
Boxed warningNone1Uterine cancers, stroke and pulmonary embolism in women using it after DCIS or to lower breast cancer risk2

Reviewed . Half-life figures are shown only where the value Dose Track uses agrees with the cited source.

What did ATAC show about side effects?

ATAC compared Arimidex 1 mg (3,092 women) with tamoxifen 20 mg (3,094 women) after surgery for early breast cancer, with a median of about 60 months of treatment.1 Beyond the table above, raised cholesterol was reported in 9% on Arimidex vs 3.5% on tamoxifen, and carpal tunnel syndrome in 2.5% vs 0.7%. Spine and hip bone density fell on average on Arimidex and rose on tamoxifen. In women who already had ischemic heart disease, heart events from reduced blood flow were 17% vs 10%. Serious adverse reactions overall were similar, 50% vs 51%.1

How do the warnings differ?

Tamoxifen has a boxed warning for women using it after DCIS or to lower breast cancer risk: in the P-1 trial, endometrial cancer was 2.20 vs 0.71 per 1,000 women-years on placebo, stroke 1.43 vs 1.00 and pulmonary embolism 0.75 vs 0.25. The label says the benefits outweigh these risks in women already diagnosed with breast cancer.2 Its other warnings cover eye changes, liver effects, blood counts and blood thinners such as warfarin. The Arimidex label warns about heart events in women with existing ischemic heart disease, bone loss, cholesterol and harm to an unborn baby.1

Both labels say the two should not be taken together; in ATAC the combination arm showed no benefit over tamoxifen alone.12 Which, if either, fits is for your prescriber. More detail: Arimidex side effects, tamoxifen side effects, the Arimidex and tamoxifen dosing schedules, the Arimidex and tamoxifen missed-dose pages, and Anastrozole vs letrozole: what is the difference?.

Frequently asked questions

Have Arimidex and tamoxifen been compared directly?+
Yes. The Arimidex label reports ATAC, which compared Arimidex 1 mg with tamoxifen 20 mg in 6,186 postmenopausal women after surgery for early breast cancer.1
Can Arimidex and tamoxifen be taken together?+
No. The Arimidex label advises against taking it with tamoxifen, and the tamoxifen label says it should not be given with anastrozole.12
What if I miss a dose?+
For Arimidex, take it as soon as you remember, but skip it if the next dose is almost due, and do not take two at once. The tamoxifen Medication Guide says to take it when you remember, and not to take extra tablets if it is almost time for the next dose.12
Can Dose Track remind me to take them?+
Yes. You can log each dose and set a reminder.