Cubicin Side Effects

Generic Name: daptomycin

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

Cubicin

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 Cubicin:

Constipation; diarrhea; dizziness; headache; nausea; pain, swelling, or redness at the injection site; sore throat; sweating; trouble sleeping; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; chest pain; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or watery stools; change in the amount of urine produced; fever; muscle pain or weakness; numbness or tingling; severe or persistent diarrhea; stomach cramps/pain; swelling (eg, of the hands, ankles, feet); symptoms of eosinophilic pneumonia (eg, new or worsening fever, cough, shortness of breath, or trouble breathing); 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.

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Cubicin Side Effects - for the Professional

Cubicin

The following adverse reactions are described, or described in greater detail, in other sections:

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Anaphylaxis/hypersensitivity reactions [see Warnings and Precautions (5.1)]

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Myopathy and rhabdomyolysis [see Warnings and Precautions (5.2)]

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Eosinophilic pneumonia [see Warnings and Precautions (5.3)]

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Peripheral neuropathy [see Warnings and Precautions (5.4)]

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Increased International Normalized Ratio (INR)/prolonged prothrombin time [see Warnings and Precautions (5.8) and Drug-Laboratory Test Interactions (7.2)]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

Clinical trials enrolled 1,864 patients treated with Cubicin and 1,416 treated with comparator.

Complicated Skin and Skin Structure Infection Trials

In Phase 3 complicated skin and skin structure infection trials, Cubicin was discontinued in 15/534 (2.8%) patients due to an adverse reaction, while comparator was discontinued in 17/558 (3.0%) patients.

The rates of the most common adverse reactions, organized by body system, observed in cSSSI (4 mg/kg Cubicin) patients are displayed in Table 4.

Table 4.  Incidence of Adverse Reactions that Occurred in ≥2% of Patients in the Cubicin Treatment Group and ≥ the Comparator Treatment Groups in Phase 3 cSSSI Trials

Adverse Reaction	Patients (%)
	Cubicin 4 mg/kg (N=534)	Comparator* (N=558)
* Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses).
Gastrointestinal disorders
Diarrhea	5.2	4.3
Nervous system disorders
Headache	5.4	5.4
Dizziness	2.2	2.0
Skin/subcutaneous disorders
Rash	4.3	3.8
Diagnostic investigations
Abnormal liver function tests	3.0	1.6
Elevated CPK	2.8	1.8
Infections
Urinary tract infections	2.4	0.5
Vascular disorders
Hypotension	2.4	1.4
Respiratory disorders
Dyspnea	2.1	1.6

Drug-related adverse reactions (possibly or probably drug-related) that occurred in <1% of patients receiving Cubicin in the cSSSI trials are as follows:

Body as a Whole: fatigue, weakness, rigors, flushing, hypersensitivity

Blood/Lymphatic System: leukocytosis, thrombocytopenia, thrombocytosis, eosinophilia, increased International Normalized Ratio (INR)

Cardiovascular System: supraventricular arrhythmia

Dermatologic System: eczema

Digestive System: abdominal distension, stomatitis, jaundice, increased serum lactate dehydrogenase

Metabolic/Nutritional System: hypomagnesemia, increased serum bicarbonate, electrolyte disturbance

Musculoskeletal System: myalgia, muscle cramps, muscle weakness, arthralgia

Nervous System: vertigo, mental status change, paresthesia

Special Senses: taste disturbance, eye irritation

S. aureus Bacteremia/Endocarditis Trial

In the S. aureus bacteremia/endocarditis trial, Cubicin was discontinued in 20/120 (16.7%) patients due to an adverse reaction, while comparator was discontinued in 21/116 (18.1%) patients.

Serious Gram-negative infections (including bloodstream infections) were reported in 10/120 (8.3%) Cubicin-treated and 0/115 comparator-treated patients.  Comparator-treated patients received dual therapy that included initial gentamicin for 4 days.  Infections were reported during treatment and during early and late follow-up.  Gram-negative infections included cholangitis, alcoholic pancreatitis, sternal osteomyelitis/mediastinitis, bowel infarction, recurrent Crohn's disease, recurrent line sepsis, and recurrent urosepsis caused by a number of different Gram-negative bacteria.

The rates of the most common adverse reactions, organized by System Organ Class (SOC), observed in S. aureus bacteremia/endocarditis (6 mg/kg Cubicin) patients are displayed in Table 5.

Table 5.  Incidence of Adverse Reactions that Occurred in ≥5% of Patients in the Cubicin Treatment Group and ≥ to the Comparator Treatment Group in the S. aureus Bacteremia/Endocarditis Trial

Adverse Reaction*	Patients n (%)
	Cubicin 6 mg/kg (N=120)	Comparator† (N=116)
* NOS, not otherwise specified. † Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 2 g IV q4h), each with initial low-dose gentamicin.
Infections and infestations
Sepsis NOS	6 (5%)	3 (3%)
Bacteremia	6 (5%)	0 (0%)
Gastrointestinal disorders
Abdominal pain NOS	7 (6%)	4 (3%)
General disorders and administration site conditions
Chest pain	8 (7%)	7 (6%)
Edema NOS	8 (7%)	5 (4%)
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain	10 (8%)	2 (2%)
Skin and subcutaneous tissue disorders
Pruritus	7 (6%)	6 (5%)
Sweating increased	6 (5%)	0 (0%)
Psychiatric disorders
Insomnia	11 (9%)	8 (7%)
Investigations
Blood creatine phosphokinase increased	8 (7%)	1 (1%)
Vascular disorders
Hypertension NOS	7 (6%)	3 (3%)

The following reactions, not included above, were reported as possibly or probably drug-related in the Cubicin-treated group:

Blood and Lymphatic System Disorders: eosinophilia, lymphadenopathy, thrombocythemia, thrombocytopenia

Cardiac Disorders: atrial fibrillation, atrial flutter, cardiac arrest

Ear and Labyrinth Disorders: tinnitus

Eye Disorders: vision blurred

Gastrointestinal Disorders: dry mouth, epigastric discomfort, gingival pain, hypoesthesia oral

Infections and Infestations: candidal infection NOS, vaginal candidiasis, fungemia, oral candidiasis, urinary tract infection fungal

Investigations: blood phosphorous increased, blood alkaline phosphatase increased, INR increased, liver function test abnormal, alanine aminotransferase increased, aspartate aminotransferase increased, prothrombin time prolonged

Metabolism and Nutrition Disorders: appetite decreased NOS

Musculoskeletal and Connective Tissue Disorders: myalgia

Nervous System Disorders: dyskinesia, paresthesia

Psychiatric Disorders: hallucination NOS

Renal and Urinary Disorders: proteinuria, renal impairment NOS

Skin and Subcutaneous Tissue Disorders: pruritus generalized, rash vesicular

Other Trials

In Phase 3 trials of community-acquired pneumonia (CAP), the death rate and rates of serious cardiorespiratory adverse events were higher in Cubicin-treated patients than in comparator-treated patients.  These differences were due to lack of therapeutic effectiveness of Cubicin in the treatment of CAP in patients experiencing these adverse events [see Indications and Usage (1.3)].

Laboratory Changes

Complicated Skin and Skin Structure Infection Trials

In Phase 3 cSSSI trials of Cubicin at a dose of 4 mg/kg, elevations in CPK were reported as clinical adverse events in 15/534 (2.8%) Cubicin-treated patients, compared with 10/558 (1.8%) comparator-treated patients.  Of the 534 patients treated with Cubicin, 1 (0.2%) had symptoms of muscle pain or weakness associated with CPK elevations to greater than 4 times the upper limit of normal (ULN).  The symptoms resolved within 3 days and CPK returned to normal within 7 to 10 days after treatment was discontinued [see Warnings and Precautions (5.2)].  Table 6 summarizes the CPK shifts from Baseline through End of Therapy in the cSSSI trials.

Table 6.  Incidence of CPK Elevations from Baseline during Therapy in Either the Cubicin Treatment Group or the Comparator Treatment Groups in Phase 3 cSSSI Trials

Change in CPK		All Patients				Patients with Normal CPK at Baseline
		Cubicin (N=430)		Comparator* (N=459)		Cubicin (N=374)		Comparator* (N=392)
		%	n	%	n	%	n	%	n
Note: Elevations in CPK observed in patients treated with Cubicin or comparator were not clinically or statistically significantly different.
* Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses). † ULN (Upper Limit of Normal) is defined as 200 U/L.
No Increase		90.7	390	91.1	418	91.2	341	91.1	357
Maximum Value	>1× ULN†	9.3	40	8.9	41	8.8	33	8.9	35
	>2× ULN	4.9	21	4.8	22	3.7	14	3.1	12
	>4× ULN	1.4	6	1.5	7	1.1	4	1.0	4
	>5× ULN	1.4	6	0.4	2	1.1	4	0.0	0
	>10× ULN	0.5	2	0.2	1	0.2	1	0.0	0

S. aureus Bacteremia/Endocarditis Trial

In the S. aureus bacteremia/endocarditis trial, at a dose of 6 mg/kg, 11/120 (9.2%) Cubicin-treated patients, including two patients with baseline CPK levels >500 U/L, had CPK elevations to levels >500 U/L, compared with 1/116 (0.9%) comparator-treated patients.  Of the 11 Cubicin-treated patients, 4 had prior or concomitant treatment with an HMG-CoA reductase inhibitor.  Three of these 11 Cubicin-treated patients discontinued therapy due to CPK elevation, while the one comparator-treated patient did not discontinue therapy [see Warnings and Precautions (5.2)].

Post-Marketing Experience

The following adverse reactions have been identified during postapproval use of Cubicin.  Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure.

Immune System Disorders: anaphylaxis; hypersensitivity reactions, including pruritus, hives, shortness of breath, difficulty swallowing, truncal erythema, and pulmonary eosinophilia [see Contraindications (4), Warnings and Precautions (5.1)]

Infections and Infestations: Clostridium difficile–associated diarrhea [see Warnings and Precautions (5.5)]

Musculoskeletal Disorders: myoglobin increased; rhabdomyolysis (some reports involved patients treated concurrently with Cubicin and HMG-CoA reductase inhibitors) [see Warnings and Precautions (5.2), Drug Interactions (7.1), and Clinical Pharmacology (12.3)]

Respiratory, Thoracic, and Mediastinal Disorders: cough, eosinophilic pneumonia [see Warnings and Precautions (5.3)]

Nervous System Disorders: peripheral neuropathy [see Warnings and Precautions (5.4)]

Skin and Subcutaneous Tissue Disorders: serious skin reactions, including Stevens-Johnson syndrome and vesiculobullous rash (with or without mucous membrane involvement)

Gastrointestinal Disorders: nausea, vomiting

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Side Effects by Body System - for Healthcare Professionals

General

Most adverse events reported in clinical trials were mild to moderate in intensity. In phase 3 complicated skin and skin structure infection trials, daptomycin was discontinued in 2.8% of patients due to a side effect, while comparator was discontinued in 3% of patients. In the Staphylococcus aureus bacteremia/endocarditis trial, daptomycin was discontinued in 16.7% of patients due to a side effect, while comparator was discontinued in 18.1% of patients.

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal disorders (unspecified; 50%), diarrhea (up to 11.7%), vomiting (up to 11.7%), constipation (up to 10.8%), nausea (up to 10%), abdominal pain (up to 5.8%), dyspepsia (up to 4.2%), loose stools (4.2%), gastrointestinal hemorrhage (1.7%), abnormal bowel sounds, and aphthous stomatitis. Abdominal distention, flatulence, stomatitis, dry mouth, epigastric discomfort, gingival pain, oral candidiasis, and oral hypoesthesia have been reported in less than 1% of patients. Clostridium difficile associated diarrhea, nausea, and vomiting have been reported during postmarketing experience.

Other

Other side effects have included infections and infestations (unspecified; 54.2%), general disorders and administration site conditions (unspecified; 44.2%), investigations (unspecified; 25%), peripheral edema (6.7%), chest pain (up to 6.7%), sepsis (5%), pneumonia (3.3%), fungal infections (2.6%), edema (up to 6.7%), Candida infections (up to 1.7%), fever (1.9%), chapped lips, adenoviral upper respiratory infection, and upper respiratory tract infection (not otherwise specified). Fatigue, weakness, rigors, discomfort, jitteriness, flushing, fungemia, and taste disturbance have been reported in less than 1% of patients. Injury, poisoning, and procedural complications (unspecified), bacteremia, and laboratory abnormalities (unspecified) have been reported. Serious Gram-negative infections and nonserious Gram-negative bloodstream infections have also been reported.

Serious and nonserious Gram-negative infections were reported in 8.3% (10/120) of daptomycin-treated patients in the Staphylococcus aureus bacteremia/endocarditis trial compared to 0/120 in comparator-treated patients. Gram-negative infections included cholangitis, alcoholic pancreatitis, sternal osteomyelitis/mediastinitis, bowel infarction, recurrent Crohn's disease, recurrent line sepsis, and recurrent urosepsis.

One patient developed S aureus endocarditis with a 2 cm mitral vegetation, bowel infarction, and polymicrobial bacteremia that ultimately lead to death following mitral valve repair complicated by sternal osteomyelitis.

Respiratory

Symptoms of eosinophilic pneumonia have included fever, dyspnea with hypoxic respiratory insufficiency, diffuse pulmonary infiltrates, cough, shortness of breath, and difficulty breathing. Eosinophilic pneumonia may lead to progressive respiratory failure and is potentially fatal if not quickly recognized and appropriately managed.

Respiratory side effects have included respiratory, thoracic, and mediastinal disorders (unspecified; 31.7%), pharyngolaryngeal pain (8.3%), pleural effusions (5.8%), dyspnea (up to 3.3%), cough (up to 3.3%), and sore throat (up to 1.7%). Cough and eosinophilic pneumonia have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included skin and subcutaneous tissue disorders (unspecified; 30%), rash (up to 6.7%), pruritus (up to 5.8%), increased sweating (5%), erythema (5%), cellulitis (up to 1.7 %), and papular rash. Eczema, heat rash, generalized pruritus, and vesicular rash have been reported in less than 1% of patients. Serious skin reactions, including Stevens-Johnson syndrome and vesiculobullous rash (with or without mucous membrane involvement) have been reported during postmarketing experience.

Musculoskeletal

A 45-year-old female with refractory acute myeloid leukemia was admitted to the blood and marrow transplant unit for a second attempt to induce remission with myeloablative chemotherapy of high-dose cytarabine. Two months prior, the patient's first course of induction therapy was complicated by neutropenic fever and vancomycin- resistant Enterococcus faecium (VRE) bacteremia that was treated with linezolid for 14 days. The patient was also receiving aztreonam, levofloxacin, acyclovir, amphotericin B lipid complex, and azithromycin. Once her clinical status stabilized, she was transferred from the intensive care unit (ICU) back to the blood and marrow transplant unit. After receiving 8 of 12 scheduled doses of cytarabine, the patient required readmission to the medical ICU due to a decrease in mental status, supraventricular tachycardia, and hypotension. Cultures of blood and urine samples at the time of her transfer showed VRE with intermediate resistance to linezolid. The patient, who was neutropenic at this time, was started on intravenous daptomycin 550 mg (6 mg/kg) every 24 hours.

The patient's baseline creatine phosphokinase (CPK) was 108 units/L and serum creatinine level was 0.8 mg/dL. Over the following 7 days, the patient's CPK level gradually increased, and on day 10 of daptomycin treatment, her CPK level was 996 units/L, blood urea nitrogen level (BUN) was 73 mg/dL, and serum creatinine level was 1.9 mg/dL. To evaluate for rhabdomyolysis, urine myoglobin was measured and reported at 30,890 ng/mL. Rhabdomyolysis was diagnosed based on increased CPK and urine myoglobin level in a patient with acute renal failure.

Daptomycin was discontinued and the patient was started on treatment for rhabdomyolysis. Despite aggressive hydration and diuresis, CPK and urine myoglobin levels continued to increase up to 5350 units/L and 47,166 ng/mL, respectively. Over 2 weeks, the patient's CPK and urine myoglobin levels slowly resolved. The final CPK and urine myoglobin levels measured were 3395 units/L and 451 ng/mL, respectively.

In another case, a 53-year-old African-American female with a history of hypertension, diabetes mellitus, and peripheral vascular disease was admitted to the hospital and an MRI revealed L5-S1 discitis and osteomyelitis. After an 8-week course of empirical antibiotic therapy with vancomycin and levofloxacin an open biopsy was performed. Specimens from the biopsy cultured positive for Torulopsis glabrata, VRE, and methicillin-resistant Staphylococcus aureus (MRSA) and the patient was started on daptomycin 360 mg (6 mg/kg) intravenously as a single daily dose and voriconazole 250 mg twice daily.

Ten days after the start of daptomycin therapy, the patient developed generalized muscular weakness that progressed to the point she was unable to get out of bed. The patient then developed nonoliguric acute renal failure with a serum creatinine of 27 mg/mL up from baseline of 9 mg/mL. A CPK level drawn was elevated to 21,243 units/L and was associated with elevated levels aspartate aminotransferase (AST) 375 units/L, alanine aminotransferase (ALT) 219 units/L, and lactate dehydrogenase (LDH) 666 units/L. Urinalysis was positive for hemoglobin, myoglobin, and red blood cells which conferred a diagnosis of acute renal failure secondary to daptomycin-induced rhabdomyolysis.

After daptomycin was discontinued and intravenous fluid was administered to alkalinize the urine, renal function, CPK, and liver function tests returned to baseline as well as dissipation of muscular weakness. Myoglobin, hemoglobin, and the red blood cells disappeared from urine as well.

In another similar case, a 52-year-old male with a history hepatitis C, intravenous drug abuse, idiopathic thrombocytopenia, and hyperlipidemia was admitted to the hospital and an MRI revealed findings compatible with L3-L4 discitis and osteomyelitis. He was started on vancomycin but it was discontinued after a rash developed. Daptomycin was started at 500 mg (6.5 mg/kg) intravenous as a single daily dose. The patient was also on simvastatin; however, it was discontinued prior to initiation of daptomycin therapy. After nine days into the course of daptomycin therapy, the patient developed generalized muscle weakness progressing to the point where he was unable to get out of bed. The patient's CPK rose to 20,771 units/L from a baseline of 102 units/L. AST 239 units/L and ALT 40 units/L were elevated from baseline and alkaline phosphatase was elevated to 118 units/L.

Daptomycin was discontinued and the patient was admitted to the intensive care unit for close monitoring and hydration. The patient slowly improved and recovered all muscle strength and within two weeks his enzymes returned to baseline.

Musculoskeletal side effects have included musculoskeletal and connective tissue disorders (unspecified; 29.2%), pain in extremity (9.2%), elevated creatine phosphokinase (CPK; up to 6.7%), back pain (up to 6.7%), arthralgia (up to 3.3%), limb pain (1.5%), and muscle twitching. Myalgia, myositis, muscle cramps, muscle weakness, and osteomyelitis have been reported in less than 1% of patients. In clinical studies, 0.2% of patients had symptoms of muscle pain or weakness associated with CPK elevations to greater than 4 times ULN. After discontinuation of daptomycin, CPK returned to normal within 7 to 10 days and symptoms resolved within 3 days. Myopathy with minor increases in creatine kinase has also been reported. Case reports of rhabdomyolysis with secondary acute renal failure and other reports of severe myopathy and possible hepatotoxicity were recorded with use of daptomycin therapy. Increased myoglobin and rhabdomyolysis (some cases involved patients treated concurrently with daptomycin and HMG-CoA reductase inhibitors) have been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included psychiatric disorders (unspecified; 29.2%) and anxiety (up to 5%).

Nervous system

Nervous system side effects have included nervous system disorders (unspecified; 26.7%), peripheral nervous system events (such as paresthesias, dysesthesias, and peripheral neuropathies; 9.2%), insomnia (up to 9.2%), headache (up to 6.7%), dizziness (up to 5.8%), and confusion (up to 1.7%). Vertigo, mental status change, hallucination, tinnitus, dyskinesia, and paresthesia have been reported in less than 1% of patients. Peripheral neuropathy has been reported during postmarketing experience.

Hematologic

Hematologic side effects have included blood and lymphatic system disorders (unspecified; 24.2%), anemia (up to 12.5%), eosinophilia (up to 1.7%), and increased INR (up to 1.7%). Leukocytosis, lymphadenopathy, thrombocythemia, thrombocytopenia, thrombocytosis, and prolonged prothrombin time have been reported in less than 1% of patients.

Metabolic

Metabolic side effects have included metabolism and nutrition disorders (unspecified; 21.7%), hypokalemia (up to 9.2%), hyperkalemia (up to 5%), increased blood phosphorous (2.5%), decreased appetite (up to 1.7%), and hypoglycemia (up to 1.7%). Hypomagnesemia, increased serum bicarbonate, and electrolyte disturbance have been reported in less than 1% of patients.

Cardiovascular

Cardiovascular side effects have included vascular disorders (unspecified; 17.5%), hypertension (up to 5.8%), hypotension (up to 5%), cardiac failure (up to 1.7%), and cardiac disorders (unspecified). Supraventricular arrhythmia, atrial fibrillation, atrial flutter, and cardiac arrest have been reported in less than 1% of patients.

Renal

Renal side effects have included renal and urinary disorders (unspecified; 15%), worsening creatinine clearance/decreased renal function (up to 11%), renal failure (up to 3.3%), acute renal failure (3.3%), and renal impairment (unspecified; less than 1%). Renal impairment (interstitial nephritis, toxic nephropathy, acute prerenal failure, acute or chronic renal failure, renal impairment, and renal tubular necrosis) has been reported.

Genitourinary

Genitourinary side effects have included urinary tract infections (up to 6.7%), vaginal candidiasis (1.7%), fungal urinary tract infection (less than 1%), proteinuria (less than 1%), vaginal discharge, and asymptomatic foamy urine.

Local

Local side effects have included injection site reactions (up to 5.8%), injection site erythema (2.5%), and injection site phlebitis.

Hepatic

Hepatic side effects have included abnormal liver function tests (up to 3%) and elevated alkaline phosphatase (up to 1.7%). Jaundice, increased lactate dehydrogenase, increased alanine aminotransferase, and increased aspartate aminotransferase have been reported in less than 1% of patients. Hepatobiliary disorder (unspecified) has been reported in at least 1 patient.

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity (unspecified) in less than 1% of patients. Anaphylaxis and hypersensitivity reactions (including pruritus, hives, shortness of breath, difficulty swallowing, truncal erythema, and pulmonary eosinophilia) have been reported during postmarketing experience.

Other

In phase 3 trials of community-acquired pneumonia, daptomycin was associated with a higher death rate and rate of serious cardiorespiratory adverse events than comparator drugs, due to lack of clinical efficacy.

Ocular

Ocular side effects have included eye irritation and blurred vision in less than 1% of patients.

Oncologic

Oncologic side effects have included benign and malignant neoplasms (unspecified).

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