Cubicin Side Effects
Generic name: daptomycin
Note: This document contains side effect information about daptomycin. Some of the dosage forms listed on this page may not apply to the brand name Cubicin.
Some side effects of Cubicin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to daptomycin: intravenous powder for solution
Along with its needed effects, daptomycin (the active ingredient contained in Cubicin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking daptomycin:More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- rapid weight gain
- tingling of the hands or feet
- unusual weight gain or loss
- Abdominal or stomach pain
- black, tarry stools
- bladder pain
- bloody or cloudy urine
- blurred vision
- chest pain or discomfort
- decreased frequency or amount of urine
- decreased urine output
- difficult or labored breathing
- difficult, burning, or painful urination
- dilated neck veins
- dry mouth
- extreme fatigue
- faintness or lightheadedness when getting up suddenly from a lying or sitting position
- fast heartbeat
- frequent urge to urinate
- increased blood pressure
- increased thirst
- irregular breathing
- irregular heartbeat
- itching in the genital or other skin areas
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- loss of appetite
- lower back or side pain
- mood changes
- muscle pain or cramps
- muscle twitching
- numbness or tingling in the hands, feet, or lips
- pale skin
- pounding in the ears
- rapid weight gain
- rapid, shallow breathing
- shortness of breath
- slow or fast heartbeat
- sore throat
- swelling of the face, fingers, ankles, or hands
- tightness in the chest
- troubled breathing with exertion
- unusual bleeding or bruising
- usual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weight gain
- Bleeding gums
- blood in the urine or stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- clay-colored stools
- dark urine
- difficulty with moving
- eye pain
- feeling of warmth
- feeling unusually cold
- general feeling of illness
- increase in bone pain
- joint pain, stiffness, or swelling
- loss of appetite
- mood or mental changes
- muscle aching or cramping
- muscle spasms (tetany) or twitching
- no blood pressure or pulse
- pain in the joints
- pinpoint red spots on the skin
- rapid or irregular heartbeat
- redness of the face, neck, arms, and occasionally, upper chest
- redness of the skin
- redness, blistering, peeling, or loosening of the skin
- skin rash, encrusted, scaly and oozing
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stopping of heart
- swelling of the eyelids, face, lips, hands, or feet
- swollen glands
- swollen joints
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- troubled breathing or swallowing
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- unpleasant breath odor
- unusual bleeding or bruising
- vomiting of blood
- yellow eyes or skin
- Abdominal or stomach cramps
- abdominal or stomach tenderness
- diarrhea, watery and severe, which may also be bloody
- difficulty with swallowing
- dry cough
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- unusual weight loss
Some side effects of daptomycin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- diarrhea, mild
- difficulty having a bowel movement (stool)
- back pain
- blurred vision
- cold sweats
- cool, pale skin
- decreased appetite
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased urination
- itching of the vagina or outside genitals
- lack or loss of strength
- limb pain
- pain during sexual intercourse
- skin rash
- slurred speech
- thick, white, curd-like vaginal discharge without odor or with mild odor
- trouble sleeping
- unable to sleep
- unexplained weight loss
- Acid or sour stomach
- bad, unusual, or unpleasant (after) taste
- change in taste
- continuing ringing or buzzing or other unexplained noise in the ears
- excess air or gas in the stomach or intestines
- feeling of constant movement of self or surroundings
- full feeling
- hearing loss
- pain or discomfort in the chest, upper stomach, or throat
- passing gas
- pressure in the stomach
- red, sore eyes
- seeing, hearing, or feeling things that are not there
- sensation of spinning
- sore mouth or tongue
- swelling of the abdominal or stomach area
- swelling or inflammation of the mouth
- white patches in the mouth or on the tongue
For Healthcare Professionals
Applies to daptomycin: intravenous powder for injection
Most adverse events reported in clinical trials were mild to moderate in intensity. In phase 3 complicated skin and skin structure infection trials, daptomycin (the active ingredient contained in Cubicin) 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 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 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.
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 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.
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 (the active ingredient contained in Cubicin) 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 side effects have included psychiatric disorders (unspecified; 29.2%) and anxiety (up to 5%).
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 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 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 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 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 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 side effects have included injection site reactions (up to 5.8%), injection site erythema (2.5%), and injection site phlebitis.
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 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.
In phase 3 trials of community-acquired pneumonia, daptomycin (the active ingredient contained in Cubicin) was associated with a higher death rate and rate of serious cardiorespiratory adverse events than comparator drugs, due to lack of clinical efficacy.
Ocular side effects have included eye irritation and blurred vision in less than 1% of patients.
Oncologic side effects have included benign and malignant neoplasms (unspecified).
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