Anastrozole Side Effects

Brand Names: Arimidex

Please note - some side effects for Anastrozole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Anastrozole - for the Consumer

Anastrozole

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Anastrozole:

Anxiety; back, bone, breast, joint, muscle, or pelvic pain; constipation; cough; diarrhea; dizziness; flu-like symptoms (eg, muscle aches, tiredness); hair loss; headache; hot flashes; loss of appetite; mild stomach pain; nausea; sore throat; stomach upset; sweating; trouble sleeping; vaginal dryness; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Anastrozole:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling sensation; calf or leg pain, swelling, or tenderness; chest pain; confusion; fainting; fever, chills, or persistent sore throat; frequent or painful urination; mental or mood changes (eg, depression); numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; severe or persistent bone pain; severe or persistent dizziness or headache; severe or persistent tiredness or weakness; shortness of breath; skin lesions, ulcers, or blisters; speech problems; swelling of the arms or legs; swollen lymph nodes; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; severe or persistent nausea, vomiting, or stomach pain; general feeling of being unwell); tingling, pain, coldness, or weakness in the fingers, wrists, or hands; vaginal bleeding or unusual discharge; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Anastrozole Side Effects - for the Professional

Anastrozole

Serious adverse reactions with Anastrozole 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 [see ADVERSE REACTIONS (6.2)].

Common adverse reactions (occurring with an incidence of >10%) in women taking Anastrozole included: hot flashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, pain, 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 Anastrozole 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

Adjuvant Therapy

Adverse reaction data for adjuvant therapy are based on the ATAC trial [see CLINICAL STUDIES (14.1)]. The median duration of adjuvant treatment for safety evaluation was 59.8 months and 59.6 months for patients receiving Anastrozole 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*

* 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. § Vaginal Hemorrhage without further diagnosis.
Body system and adverse reactions by COSTART† preferred term	Anastrozole 1 mg (N‡ = 3092)	Tamoxifen 20 mg (N‡ = 3094)
Body as a whole
Asthenia	575 (19)	544 (18)
Pain	533 (17)	485 (16)
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)
Cardiovascular
Vasodilatation	1104 (36)	1264 (41)
Hypertension	402 (13)	349 (11)
Digestive
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)
Musculoskeletal
Arthritis	512 (17)	445 (14)
Arthralgia	467 (15)	344 (11)
Osteoporosis	325 (11)	226 (7)
Fracture	315 (10)	209 (7)
Bone pain	201 (7)	185 (6)
Arthrosis	207 (7)	156 (5)
Joint Disorder	184 (6)	160 (5)
Myalgia	179 (6)	160 (5)
Nervous system
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)
Respiratory
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)
Special Senses
Cataract Specified	182 (6)	213 (7)
Urogenital
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)

N=Number of patients receiving the treatment.

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.

Table 2 - Number of Patients with Pre-specified Adverse Reactions in ATAC Trial*

* 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
	Anastrozole N=3092 (%)	Tamoxifen N=3094 (%)	Odds-ratio	95% CI
Hot Flashes	1104 (36)	1264 (41)	0.80	0.73 − 0.89
Musculoskeletal Events†	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

Ischemic Cardiovascular Events

Between treatment arms in the overall population of 6186 patients, there was no statistical difference in ischemic cardiovascular events (4% Anastrozole vs. 3% tamoxifen). In the overall population, angina pectoris was reported in 71/3092 (2.3%) patients in the Anastrozole arm and 51/3094 (1.6%) patients in the tamoxifen arm; myocardial infarction was reported in 37/3092 (1.2%) patients in the Anastrozole 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 Anastrozole and 10% in patients on tamoxifen. In this patient population, angina pectoris was reported in 25/216 (11.6%) patients receiving Anastrozole and 13/249 (5.2%) patients receiving tamoxifen; myocardial infarction was reported in 2/216 (0.9%) patients receiving Anastrozole 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 Anastrozole 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 Anastrozole lowers circulating estrogen levels it may cause a reduction in bone mineral density.

A post-marketing trial assessed the combined effects of Anastrozole 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 Anastrozole should have their bone status managed according to treatment guidelines already available for postmenopausal women at similar risk of fragility fracture.

Cholesterol

During the ATAC trial, more patients receiving Anastrozole 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 Anastrozole on lipid profile. In the primary analysis population for lipids (Anastrozole 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 (Anastrozole+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 Anastrozole alone had a neutral effect on lipid profile. Combination treatment with Anastrozole 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 Anastrozole 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 Anastrozole had an increase in joint disorders (including arthritis, arthrosis and arthralgia) compared with patients receiving tamoxifen. Patients receiving Anastrozole 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 Anastrozole 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 Anastrozole-treated patients 317 (10%) versus 167 (5%), respectively.

Patients receiving Anastrozole 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 Anastrozole (50%) and tamoxifen (51%).
• Cardiovascular events were consistent with the known safety profiles of Anastrozole and tamoxifen.
• The cumulative incidences of all first fractures (both serious and non-serious, occurring either during or after treatment) was higher in the Anastrozole 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 Anastrozole 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 Anastrozole 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 Anastrozole treatment group.

First-Line Therapy

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

* A patient may have had more than 1 adverse event.
Body system Adverse Reaction*	Number (%) of subjects
	Anastrozole (n=506)	Tamoxifen (n=511)
Whole body
Asthenia	83 (16)	81 (16)
Pain	70 (14)	73 (14)
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)
Cardiovascular
Vasodilation	128 (25)	106 (21)
Hypertension	25 (5)	36 (7)
Digestive
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)
Muscoloskeletal
Bone pain	54 (11)	52 (10)
Nervous
Dizziness	30 (6)	22 (4)
Insomnia	30 (6)	38 (7)
Depression	23 (5)	32 (6)
Hypertonia	16 (3)	26 (5)
Respiratory
Cough increased	55 (11)	52 (10)
Dyspnea	51 (10)	47 (9)
Pharyngitis	49 (10)	68 (13)
Skin and appendages
Rash	38 (8)	34 (8)
Urogenital
Leukorrhea	9 (2)	31 (6)

Less frequent adverse experiences reported in patients receiving Anastrozole 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

* A patient may have had more than 1 adverse event. † Includes pulmonary embolus, thrombophlebitis, retinal vein thrombosis. ‡ Includes myocardial infarction, myocardial ischemia, angina pectoris, cerebrovascular accident, cerebral ischemia and cerebral infarct.
	Number (n) and Percentage of Patients
Adverse Reaction*	Anastrozole 1 mg (n=506) n (%)	NOLVADEX20 mg (n=511) n (%)
Depression	23 (5)	32 (6)
Tumor Flare	15 (3)	18 (4)
Thromboembolic Disease†	18 (4)	33 (6)
Venous†	5	15
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)

Second-Line Therapy

Anastrozole was tolerated in two controlled clinical trials (i.e., Trials 0004 and 0005), with less than 3.3% of the Anastrozole-treated patients and 4.0% of the megestrol acetate-treated patients withdrawing due to an adverse reaction.

The principal adverse reaction more common with Anastrozole 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

* A patient may have had more then one adverse reaction.
Adverse Reaction*	Anastrozole 1 mg (n=262)		Anastrozole 10 mg (n=246)		Megestrol Acetate 160 mg (n=253)
	n	%	n	%	n	%
Asthenia	42	(16)	33	(13)	47	(19)
Nausea	41	(16)	48	(20)	28	(11)
Headache	34	(13)	44	(18)	24	(9)
Hot Flashes	32	(12)	29	(11)	21	(8)
Pain	28	(11)	38	(15)	29	(11)
Back Pain	28	(11)	26	(11)	19	(8)
Dyspnea	24	(9)	27	(11)	53	(21)
Vomiting	24	(9)	26	(11)	16	(6)
Cough Increased	22	(8)	18	(7)	19	(8)
Diarrhea	22	(8)	18	(7)	7	(3)
Constipation	18	(7)	18	(7)	21	(8)
Abdominal Pain	18	(7)	14	(6)	18	(7)
Anorexia	18	(7)	19	(8)	11	(4)
Bone Pain	17	(6)	26	(12)	19	(8)
Pharyngitis	16	(6)	23	(9)	15	(6)
Dizziness	16	(6)	12	(5)	15	(6)
Rash	15	(6)	15	(6)	19	(8)
Dry Mouth	15	(6)	11	(4)	13	(5)
Peripheral Edema	14	(5)	21	(9)	28	(11)
Pelvic Pain	14	(5)	17	(7)	13	(5)
Depression	14	(5)	6	(2)	5	(2)
Chest Pain	13	(5)	18	(7)	13	(5)
Paresthesia	12	(5)	15	(6)	9	(4)
Vaginal Hemorrhage	6	(2)	4	(2)	13	(5)
Weight Gain	4	(2)	9	(4)	30	(12)
Sweating	4	(2)	3	(1)	16	(6)
Increased Appetite	0	(0)	1	(0)	13	(5)

Other less frequent (2% to 5%) adverse reactions reported in patients receiving Anastrozole 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

Hepatic: Gamma GT increased; SGOT increased; SGPT increased

Hematologic: Anemia; leucopenia

Metabolic and Nutritional: Alkaline phosphatase increased; weight loss

Mean serum total cholesterol levels increased by 0.5 mmol/L among patients receiving Anastrozole.

Increases in LDL cholesterol have been shown to contribute to these changes.

Musculoskeletal: Myalgia; arthralgia; pathological fracture

Nervous: Somnolence; confusion; insomnia; anxiety; nervousness

Respiratory: Sinusitis; bronchitis; rhinitis

Skin and Appendages: Hair thinning (alopecia); pruritus

Urogenital: Urinary tract infection; breast pain

The incidences of the following adverse event 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

	Anastrozole 1 mg (N=262)		Anastrozole 10 mg (N=246)		Megestrol Acetate 160 mg (N=253)
Adverse Event Group	N	(%)	N	(%)	N	(%)
Gastrointestinal Disturbance	77	(29)	81	(33)	54	(21)
Hot Flushes	33	(13)	29	(12)	35	(14)
Edema	19	(7)	28	(11)	35	(14)
Thromboembolic Disease	9	(3)	4	(2)	12	(5)
Vaginal Dryness	5	(2)	3	(1)	2	(1)
Weight Gain	4	(2)	10	(4)	30	(12)

Post-Marketing Experience

Hepatobiliary events including increases in alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase have been reported (>1% and <10%) and gamma-GT, bilirubin and hepatitis have been reported (>0.1% and <1%) in patients receiving Anastrozole.

Anastrozole may also be associated with rash including cases of mucocutaneous disorders such as erythema multiforme and Stevens-Johnson syndrome.

Cases of allergic reactions including angioedema, urticaria and anaphylaxis have been reported in patients receiving Anastrozole. [see CONTRAINDICATIONS (4.2)]

Trigger finger has been reported (>0.1% and <1%) in patients receiving Anastrozole.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects (up to 33%) have included nausea (up to 20%), vomiting (up to 11%), diarrhea (up to 8%), constipation (up to 8%), and abdominal pain (up to 8%).

Other

Other side effects have included headache (up to 18%), hot flushes (up to 13%), pain (up to 15%), and chest pain (up to 7%).

General

General side effects have included asthenia (up to 16%).

Musculoskeletal

Musculoskeletal side effects have included arthritis (up to 17%), arthralgia (up to 15%), bone pain (up to 12%), osteoporosis (up to 11%), fracture (up to 10%), and back pain (up to 11%).

Respiratory

Respiratory side effects have included dyspnea (up to 11%), pharyngitis (up to 9%), increased cough (up to 8%), and dry mouth (up to 6%).

Cardiovascular

Cardiovascular side effects have included hypertension (up to 13%), edema (up to 11%), including peripheral edema (up to 9%). Ischemic cardiovascular disease (4%) has also been reported.

Genitourinary

Genitourinary side effects include pelvic pain (up to 7%).

Dermatologic

Dermatologic side effects have included rash (up to 11%) and alopecia. Very rare cases of mucocutaneous disorders such as erythema multiforme and Stevens-Johnson syndrome have also been associated with the use of anastrozole. Henoch-Schonlein purpura has been reported. A case of subacute cutaneous lupus erythematosus has also been reported.

Nervous system

Nervous system side effects have included insomnia (up to 10%), dizziness (up to 6%), paresthesia (up to 6%), and carpal tunnel syndrome.

Psychiatric

Psychiatric side effects have included depression (up to 5%).

Hepatic

Hepatic side effects have been reported including a case of severe acute hepatitis in a patient treated with anastrozole.

Hematologic

Hematologic side effects have included lymphedema (10%) and anemia (4%).

Metabolic

Metabolic side effects have included hypercholesterolemia (up to 9%).

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