Zometa Side Effects

Generic Name: zoledronic acid

Please note - some side effects for Zometa 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 Zometa - for the Consumer

Zometa

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 Zometa:

Back pain; constipation; cough; decreased appetite; diarrhea; dizziness; fatigue; headache; mild muscle or joint aches; mild pain, swelling, or redness at the injection site; nausea; sore throat; stomach pain or upset; trouble sleeping; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision changes; change in the amount of urine produced; chest pain; fainting; fever or chills; irregular or slow heartbeat; jaw pain or swelling; mental or mood changes (eg, agitation, anxiety, depression); muscle cramps or spasms; numbness or tingling of the lips, tongue, fingers, or feet; redness, pain, or swelling of the eyes; severe bone, joint, or muscle pain; severe dizziness; shortness of breath; swelling of the ankles or feet; unusual bruising or bleeding; unusual tiredness or weakness.

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.

Top

Zometa Side Effects - for the Professional

Zometa

Clinical Studies Experience

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.

Hypercalcemia of Malignancy

The safety of Zometa was studied in 185 patients with hypercalcemia of malignancy (HCM) who received either Zometa 4 mg given as a 5-minute intravenous infusion (n=86) or pamidronate 90 mg given as a 2-hour intravenous infusion (n=103). The population was aged 33-84 years, 60% male and 81% Caucasian, with breast, lung, head and neck, and renal cancer as the most common forms of malignancy. NOTE: pamidronate 90 mg was given as a 2-hour intravenous infusion. The relative safety of pamidronate 90 mg given as a 2-hour intravenous infusion compared to the same dose given as a 24-hour intravenous infusion has not been adequately studied in controlled clinical trials.

Renal Toxicity

Administration of Zometa 4 mg given as a 5-minute intravenous infusion has been shown to result in an increased risk of renal toxicity, as measured by increases in serum creatinine, which can progress to renal failure. The incidence of renal toxicity and renal failure has been shown to be reduced when Zometa 4 mg is given as a 15-minute intravenous infusion. Zometa should be administered by intravenous infusion over no less than 15 minutes [see Warnings And Precautions (5) and Dosage And Administration (2)].

The most frequently observed adverse events were fever, nausea, constipation, anemia, and dyspnea.

Table 4 provides adverse events that were reported by 10% or more of the 189 patients treated with Zometa 4 mg or Pamidronate 90 mg from the two HCM trials. Adverse events are listed regardless of presumed causality to study drug.

Table 4: Percentage of Patients with Adverse Events ≥10% Reported in Hypercalcemia of Malignancy Clinical Trials by Body System

	Zometa		Pamidronate
	4 mg		90 mg
	n (%)		n (%)
Patients Studied
Total No. of Patients Studied	86	(100)	103	(100)
Total No. of Patients with any AE	81	(94)	95	(92)
Body as a Whole
Fever	38	(44)	34	(33)
Progression of Cancer	14	(16)	21	(20)
Cardiovascular
Hypotension	9	(11)	2	(2)
Digestive
Nausea	25	(29)	28	(27)
Constipation	23	(27)	13	(13)
Diarrhea	15	(17)	17	(17)
Abdominal Pain	14	(16)	13	(13)
Vomiting	12	(14)	17	(17)
Anorexia	8	(9)	14	(14)
Hemic and Lymphatic System
Anemia	19	(22)	18	(18)
Infections
Moniliasis	10	(12)	4	(4)
Laboratory Abnormalities
Hypophosphatemia	11	(13)	2	(2)
Hypokalemia	10	(12)	16	(16)
Hypomagnesemia	9	(11)	5	(5)
Musculoskeletal
Skeletal Pain	10	(12)	10	(10)
Nervous
Insomnia	13	(15)	10	(10)
Anxiety	12	(14)	8	(8)
Confusion	11	(13)	13	(13)
Agitation	11	(13)	8	(8)
Respiratory
Dyspnea	19	(22)	20	(19)
Coughing	10	(12)	12	(12)
Urogenital
Urinary Tract Infection	12	(14)	15	(15)

The following adverse events from the two controlled multicenter HCM trials (n=189) were reported by a greater percentage of patients treated with Zometa 4 mg than with pamidronate 90 mg and occurred with a frequency of greater than or equal to 5% but less than 10%. Adverse events are listed regardless of presumed causality to study drug: Asthenia, chest pain, leg edema, mucositis, dysphagia, granulocytopenia, thrombocytopenia, pancytopenia, nonspecific infection, hypocalcemia, dehydration, arthralgias, headache and somnolence.

Rare cases of rash, pruritus, and chest pain have been reported following treatment with Zometa.

Acute Phase Reaction-like Events

Symptoms consistent with acute phase reaction (APR) can occur with intravenous bisphosphonate use. Fever has been the most commonly associated symptom, occurring in 44% of patients treated with Zometa 4 mg and 33% of patients treated with Pamidronate 90 mg. Occasionally, patients experience a flu-like syndrome consisting of fever, chills, flushing, bone pain and/or arthralgias, and myalgias.

Mineral and Electrolyte Abnormalities

Electrolyte abnormalities, most commonly hypocalcemia, hypophosphatemia and hypomagnesemia, can occur with bisphosphonate use.

Grade 3 and Grade 4 laboratory abnormalities for serum creatinine, serum calcium, serum phosphorus, and serum magnesium observed in two clinical trials of Zometa in patients with HCM are shown in Table 5 and 6.

Table 5: Grade 3 Laboratory Abnormalities for Serum Creatinine, Serum Calcium, Serum Phosphorus, and Serum Magnesium in Two Clinical Trials in Patients with HCM

	Grade 3
Laboratory Parameter	Zometa		Pamidronate
	4 mg		90 mg
	n/N	(%)	n/N	(%)
Serum Creatinine1	2/86	(2%)	3/100	(3%)
Hypocalcemia2	1/86	(1%)	2/100	(2%)
Hypophosphatemia3	36/70	(51%)	27/81	(33%)
Hypomagnesemia4	0/71	—	0/84	—

Table 6: Grade 4 Laboratory Abnormalities for Serum Creatinine, Serum Calcium, Serum Phosphorus, and Serum Magnesium in Two Clinical Trials in Patients with HCM

	Grade 4
Laboratory Parameter	Zometa		Pamidronate
	4 mg		90 mg
	n/N	(%)	n/N	(%)
Serum Creatinine1	0/86	—	1/100	(1%)
Hypocalcemia2	0/86	—	0/100	—
Hypophosphatemia3	1/70	(1%)	4/81	(5%)
Hypomagnesemia4	0/71	—	1/84	(1%)
1 Grade 3 (greater than 3x Upper Limit of Normal); Grade 4 (greater than 6x Upper Limit of Normal) 2 Grade 3 (less than 7 mg/dL); Grade 4 (less than 6 mg/dL) 3 Grade 3 (less than 2 mg/dL); Grade 4 (less than 1 mg/dL) 4 Grade 3 (less than 0.8 mEq/L); Grade 4 (less than 0.5 mEq/L)

Injection Site Reactions

Local reactions at the infusion site, such as redness or swelling, were observed infrequently. In most cases, no specific treatment is required and the symptoms subside after 24-48 hours.

Ocular Adverse Events

Ocular inflammation such as uveitis and scleritis can occur with bisphosphonate use, including Zometa. No cases of iritis, scleritis or uveitis were reported during these clinical trials. However, cases have been seen in postmarketing use [see Adverse Reactions (6.2)].

Multiple Myeloma and Bone Metastases of Solid Tumors

The safety analysis includes patients treated in the core and extension phases of the trials. The analysis includes the 2,042 patients treated with Zometa 4 mg, pamidronate 90 mg, or placebo in the three controlled multicenter bone metastases trials, including 969 patients completing the efficacy phase of the trial, and 619 patients that continued in the safety extension phase. Only 347 patients completed the extension phases and were followed for 2 years (or 21 months for the other solid tumor patients). The median duration of exposure for safety analysis for Zometa 4 mg (core plus extension phases) was 12.8 months for breast cancer and multiple myeloma, 10.8 months for prostate cancer, and 4.0 months for other solid tumors.

Table 7 describes adverse events that were reported by 10% or more of patients. Adverse events are listed regardless of presumed causality to study drug.

Table 7: Percentage of Patients with Adverse Events ≥10% Reported in Three Bone Metastases Clinical Trials by Body System

	Zometa		Pamidronate		Placebo
	4 mg		90 mg
	n (%)		n (%)		n (%)
Patients Studied
Total No. of Patients	1031	(100)	556	(100)	455	(100)
Total No. of Patients with any AE	1015	(98)	548	(99)	445	(98)
Blood and Lymphatic
Anemia	344	(33)	175	(32)	128	(28)
Neutropenia	124	(12)	83	(15)	35	(8)
Thrombocytopenia	102	(10)	53	(10)	20	(4)
Gastrointestinal
Nausea	476	(46)	266	(48)	171	(38)
Vomiting	333	(32)	183	(33)	122	(27)
Constipation	320	(31)	162	(29)	174	(38)
Diarrhea	249	(24)	162	(29)	83	(18)
Abdominal Pain	143	(14)	81	(15)	48	(11)
Dyspepsia	105	(10)	74	(13)	31	(7)
Stomatitis	86	(8)	65	(12)	14	(3)
Sore Throat	82	(8)	61	(11)	17	(4)
General Disorders and Administration Site
Fatigue	398	(39)	240	(43)	130	(29)
Pyrexia	328	(32)	172	(31)	89	(20)
Weakness	252	(24)	108	(19)	114	(25)
Edema Lower Limb	215	(21)	126	(23)	84	(19)
Rigors	112	(11)	62	(11)	28	(6)
Infections
Urinary Tract Infection	124	(12)	50	(9)	41	(9)
Upper Respiratory Tract Infection	101	(10)	82	(15)	30	(7)
Metabolism
Anorexia	231	(22)	81	(15)	105	(23)
Weight Decreased	164	(16)	50	(9)	61	(13)
Dehydration	145	(14)	60	(11)	59	(13)
Appetite Decreased	130	(13)	48	(9)	45	(10)
Musculoskeletal
Bone Pain	569	(55)	316	(57)	284	(62)
Myalgia	239	(23)	143	(26)	74	(16)
Arthralgia	216	(21)	131	(24)	73	(16)
Back Pain	156	(15)	106	(19)	40	(9)
Pain in Limb	143	(14)	84	(15)	52	(11)
Neoplasms
Malignant Neoplasm Aggravated	205	(20)	97	(17)	89	(20)
Nervous
Headache	191	(19)	149	(27)	50	(11)
Dizziness (excluding vertigo)	180	(18)	91	(16)	58	(13)
Insomnia	166	(16)	111	(20)	73	(16)
Paresthesia	149	(15)	85	(15)	35	(8)
Hypoesthesia	127	(12)	65	(12)	43	(10)
Psychiatric
Depression	146	(14)	95	(17)	49	(11)
Anxiety	112	(11)	73	(13)	37	(8)
Confusion	74	(7)	39	(7)	47	(10)
Respiratory
Dyspnea	282	(27)	155	(28)	107	(24)
Cough	224	(22)	129	(23)	65	(14)
Skin
Alopecia	125	(12)	80	(14)	36	(8)
Dermatitis	114	(11)	74	(13)	38	(8)

Grade 3 and Grade 4 laboratory abnormalities for serum creatinine, serum calcium, serum phosphorus, and serum magnesium observed in three clinical trials of Zometa in patients with bone metastases are shown in Tables 8 and 9.

Table 8: Grade 3 Laboratory Abnormalities for Serum Creatinine, Serum Calcium, Serum Phosphorus, and Serum Magnesium in Three Clinical Trials in Patients with Bone Metastases

	Grade 3
Laboratory Parameter	Zometa		Pamidronate		Placebo
	4 mg		90 mg
	n/N	(%)	n/N	(%)	n/N	(%)
Serum Creatinine1*	7/529	(1%)	4/268	(2%)	4/241	(2%)
Hypocalcemia2	6/973	(<1%)	4/536	(<1%)	0/415	—
Hypophosphatemia3	115/973	(12%)	38/537	(7%)	14/415	(3%)
Hypermagnesemia4	19/971	(2%)	2/535	(<1%)	8/415	(2%)
Hypomagnesemia5	1/971	(<1%)	0/535	—	1/415	(<1%)
1 Grade 3 (greater than 3x Upper Limit of Normal); Grade 4 (greater than 6x Upper Limit of Normal) * Serum creatinine data for all patients randomized after the 15-minute infusion amendment 2 Grade 3 (less than 7 mg/dL); Grade 4 (less than 6 mg/dL) 3 Grade 3 (less than 2 mg/dL); Grade 4 (less than 1 mg/dL) 4 Grade 3 (greater than 3 mEq/L); Grade 4 (greater than 8 mEq/L) 5 Grade 3 (less than 0.9 mEq/L); Grade 4 (less than 0.7 mEq/L)

Table 9: Grade 4 Laboratory Abnormalities for Serum Creatinine, Serum Calcium, Serum Phosphorus, and Serum Magnesium in Three Clinical Trials in Patients with Bone Metastases

	Grade 4
Laboratory Parameter	Zometa		Pamidronate		Placebo
	4 mg		90 mg
	n/N	(%)	n/N	(%)	n/N	(%)
Serum Creatinine1*	2/529	(<1%)	1/268	(<1%)	0/241	—
Hypocalcemia2	7/973	(<1%)	3/536	(<1%)	2/415	(<1%)
Hypophosphatemia3	5/973	(<1%)	0/537	—	1/415	(<1%)
Hypermagnesemia4	0/971	—	0/535	—	2/415	(<1%)
Hypomagnesemia5	2/971	(<1%)	1/535	(<1%)	0/415	—
1 Grade 3 (greater than 3x Upper Limit of Normal); Grade 4 (greater than 6x Upper Limit of Normal) * Serum creatinine data for all patients randomized after the 15-minute infusion amendment 2 Grade 3 (less than 7 mg/dL); Grade 4 (less than 6 mg/dL) 3 Grade 3 (less than 2 mg/dL); Grade 4 (less than 1 mg/dL) 4 Grade 3 (greater than 3 mEq/L); Grade 4 (greater than 8 mEq/L) 5 Grade 3 (less than 0.9 mEq/L); Grade 4 (less than 0.7 mEq/L)

Among the less frequently occurring adverse events (less than 15% of patients), rigors, hypokalemia, influenza-like illness, and hypocalcemia showed a trend for more events with bisphosphonate administration (Zometa 4 mg and pamidronate groups) compared to the placebo group.

Less common adverse events reported more often with Zometa 4 mg than pamidronate included decreased weight, which was reported in 16% of patients in the Zometa 4 mg group compared with 9% in the pamidronate group. Decreased appetite was reported in slightly more patients in the Zometa 4 mg group (13%) compared with the pamidronate (9%) and placebo (10%) groups, but the clinical significance of these small differences is not clear.

Renal Toxicity

In the bone metastases trials, renal deterioration was defined as an increase of 0.5 mg/dL for patients with normal baseline creatinine (less than 1.4 mg/dL) or an increase of 1.0 mg/dL for patients with an abnormal baseline creatinine (greater than or equal to1.4 mg/dL). The following are data on the incidence of renal deterioration in patients receiving Zometa 4 mg over 15 minutes in these trials.

Table 10: Percentage of Patients with Treatment Emergent Renal Function Deterioration by Baseline Serum Creatinine*

Patient Population/Baseline Creatinine
Multiple Myeloma and Breast Cancer	Zometa 4 mg		Pamidronate 90 mg
	n/N	(%)	n/N	(%)
Normal	27/246	(11%)	23/246	(9%)
Abnormal	2/26	(8%)	2/22	(9%)
Total	29/272	(11%)	25/268	(9%)
Solid Tumors	Zometa 4 mg		Placebo
	n/N	(%)	n/N	(%)
Normal	17/154	(11%)	10/143	(7%)
Abnormal	1/11	(9%)	1/20	(5%)
Total	18/165	(11%)	11/163	(7%)
Prostate Cancer	Zometa 4 mg			Placebo
	n/N	(%)	n/N	(%)
Normal	12/82	(15%)	8/68	(12%)
Abnormal	4/10	(40%)	2/10	(20%)
Total	16/92	(17%)	10/78	(13%)
*Table includes only patients who were randomized to the trial after a protocol amendment that lengthened the infusion duration of Zometa to 15 minutes.

The risk of deterioration in renal function appeared to be related to time on study, whether patients were receiving Zometa (4 mg over 15 minutes), placebo, or pamidronate.

In the trials and in postmarketing experience, renal deterioration, progression to renal failure and dialysis have occurred in patients with normal and abnormal baseline renal function, including patients treated with 4 mg infused over a 15-minute period. There have been instances of this occurring after the initial Zometa dose.

Postmarketing Experience

The following adverse reactions have been reported during postapproval use of Zometa. Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Osteonecrosis of the Jaw

Cases of osteonecrosis (primarily involving the jaws) have been reported predominantly in cancer patients treated with intravenous bisphosphonates including Zometa. Many of these patients were also receiving chemotherapy and corticosteroids which may be a risk factor for ONJ. Data suggests a greater frequency of reports of ONJ in certain cancers, such as advanced breast cancer and multiple myeloma. The majority of the reported cases are in cancer patients following invasive dental procedures, such as tooth extraction. It is therefore prudent to avoid invasive dental procedures as recovery may be prolonged [see Warnings And Precautions (5)].

Musculoskeletal Pain

Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported with bisphosphonate use [see Warnings And Precautions (5)].

Ocular Adverse Events

Cases of uveitis, scleritis, episcleritis, conjunctivitis, iritis, and orbital inflammation including orbital edema have been reported during postmarketing use. In some cases, symptoms resolved with topical steroids.

Hypersensitivity Reactions

There have been rare reports of allergic reaction with intravenous zoledronic acid including angioedema, and bronchoconstriction. Very rare cases of anaphylactic reaction/shock have also been reported.

Additional adverse reactions reported in postmarketing use include:

CNS: taste disturbance, hyperesthesia, tremor; Special Senses: blurred vision; Gastrointestinal: dry mouth; Skin: Increased sweating; Musculoskeletal: muscle cramps; Cardiovascular: hypertension, bradycardia, hypotension (associated with syncope or circulatory collapse primarily in patients with underlying risk factors); Respiratory: bronchoconstriction; Renal: hematuria, proteinuria; General Disorders and Administration Site: weight increase, influenza-like illness (pyrexia, asthenia, fatigue or malaise) persisting for greater than 30 days; Laboratory Abnormalities: hyperkalemia, hypernatremia.

Top

Side Effects by Body System - for Healthcare Professionals

General

In general, side effects have been mild and transient and similar to other bisphosphonates. Postmarketing reports have included weight gain.

Metabolic

Metabolic side effects have included hypomagnesemia (10.5%), hypokalemia (11.6%), hypophosphatemia (12.8%), and dehydration and hypocalcemia have been reported in 5% to 10% of patients. Grade 3 and 4 laboratory abnormalities have included hypophosphatemia (51.4%, grade 3; 1.4%, grade 4) and hypocalcemia (1.2%, grade 3).

Renal

Renal side effects have included renal toxicity (deterioration of renal function or renal failure). Grade 3 increases (more than 3 times upper limit of normal) in serum creatinine have been reported in 2.3% of patients. Postmarketing reports have included hematuria, proteinuria, hyperkalemia, and hypernatremia.

Hematologic

Hematologic side effects have included anemia (22.1% to 33%) and neutropenia (12%). Granulocytopenia, thrombocytopenia, and pancytopenia have been reported in 5% to 10% of patients.

Gastrointestinal

Gastrointestinal side effects have included nausea (46% to 29.1%), vomiting (14% to 32%), constipation (26.7% to 31%), diarrhea (17.4% to 24%), abdominal pain (14% to 16.3%), dyspepsia (10%), anorexia (9.3%), stomatitis (8%), sore throat (8%), and dysphagia (5% to 10%). Postmarketing reports have included reports of dry mouth.

Ocular

Ocular side effects have included conjunctivitis. Cases of uveitis and episcleritis have been reported during post approval use. Postmarketing reports have included blurred vision. Cases of uveitis, scleritis, episcleritis, conjunctivitis, iritis, and orbital inflammation including orbital edema have been reported during postmarketing use. In some cases, symptoms resolved with topical steroids.

Cardiovascular

Cardiovascular side effects have included hypotension (10.5%). Postmarketing reports have included atrial fibrillation, hypertension, bradycardia, and hypotension.

In the postmenopausal osteoporosis trial, adjudicated serious adverse events of atrial fibrillation in the zoledronic acid treatment group occurred in 1.3% of patients (50 out of 3862) compared to 0.4% (17 out of 3852) in the placebo group. The overall incidence of all atrial fibrillation adverse events in the zoledronic acid treatment group was, reported in 2.5% of patients (96 out of 3862) in the Reclast group vs. 1.9% of patients (75 out of 3852) in the placebo group.

Musculoskeletal

Musculoskeletal side effects have included bone pain (55%), myalgia (23%0, arthralgia (21%), back pain (15%), and limb pain (14%). Postmarketing reports have included muscle cramps. Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported with bisphosphonate use. Cases of osteonecrosis (primarily involving the jaws) have been reported predominantly in cancer patients treated with intravenous bisphosphonates including zoledronic acid

Nervous system

Nervous system side effects have included headache (19%), dizziness (18%), insomnia (15.1%), paresthesia (15%), anxiety (14%), confusion (12.8%), agitation (12.8%), hypoesthesia (12%), and somnolence (5% to 10%). Postmarketing reports have included taste disturbance, hyperesthesia, tremor, and vertigo.

Respiratory

Respiratory side effects have included dyspnea (27% to 22.1%), coughing (22% to 11.6%), upper respiratory infection (10%), and pleural effusion (5% to 10%). Postmarketing reports have included bronchoconstriction.

Genitourinary

Genitourinary side effects have included urinary tract infection (14%).

Oncologic

Oncologic side effects have included aggravation of malignant neoplasm and progression of cancer.

Other

Other side effects have included fever (44.2%) and moniliasis (11.6%). Nonspecific infections, asthenia, chest pain, leg edema, and mucositis have been reported in 5% to 10% of patients. Flu-like syndromes have also been reported.

Fever is the most common adverse effect associated with zoledronic acid infusion.

Flu-like syndromes including fever, chills, bone pain, and/or arthralgias and myalgias have also occasionally been reported. These symptoms generally did not require treatment and resolved within 24 to 48 hours.

Local

Local side effects have infrequently included redness or swelling at the injection site. Postmarketing reports have included itching and pain at the injection site.

Dermatologic

Dermatologic side effects have included alopecia (12%) and dermatitis (11%). Rash and pruritus have been reported rarely. Postmarketing reports have included increased sweating and urticaria.

Psychiatric

Psychiatric side effects have included depression (14%), anxiety (11%), and confusion (7%).

Hypersensitivity

Hypersensitivity side effects have included rare cases of urticaria and angioedema and very rare cases of anaphylactic shock.

Other

Other side effects have included postmarketing reports of pyrexia, asthenia, fatigue, or malaise persisting for greater than 30 days.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.