Epzicom Side Effects
Please note - some side effects for Epzicom may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Epzicom - for the Consumer
Epzicom
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 Epzicom:
Seek medical attention right away if any of these SEVERE side effects occur when using Epzicom:Abnormal dreams; anxiety; dizziness; headache; sleeplessness.
TopSevere allergic reactions (fever; rash; tiredness; achiness; nausea; diarrhea; vomiting; stomach pain; sore throat; hives; itching; difficulty breathing; cough; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort, numbness of an arm or leg, shortness of breath, or sudden vision changes; dark urine; decreased urination; depression; exhaustion; fainting; flu-like illness; mouth ulcers; muscle pain or weakness; numbness, tingling, or pain in hands and feet; red, swollen, blistered, or peeling skin; seizures; severe dizziness; severe muscle, stomach, or chest pain or cramping; swelling; unusual or persistent tiredness; unusual weakness; yellowing of the eyes or skin.
Epzicom Side Effects - for the Professional
Epzicom
Abacavir:
Hypersensitivity Reaction:Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of Epzicom.
In one study, once-daily dosing of ZIAGEN was associated with more severe hypersensitivity reactions.
Therapy-Naive Adults:
Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a ≥5% frequency during therapy with ZIAGEN 600 mg once daily or ZIAGEN 300 mg twice daily, both in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily are listed in Table 4.
| Adverse Event |
ZIAGEN 600 mg q.d. plus EPIVIR plus Efavirenz (n = 384) |
ZIAGEN 300 mg b.i.d. plus EPIVIR plus Efavirenz (n = 386) |
| Drug hypersensitivity*† | 9% | 7% |
| Insomnia | 7% | 9% |
| Depression/Depressed mood | 7% | 7% |
| Headache/Migraine | 7% | 6% |
| Fatigue/Malaise | 6% | 8% |
| Dizziness/Vertigo | 6% | 6% |
| Nausea | 5% | 6% |
| Diarrhea* | 5% | 6% |
| Rash | 5% | 5% |
| Pyrexia | 5% | 3% |
| Abdominal pain/gastritis | 4% | 5% |
| Abnormal dreams | 4% | 5% |
| Anxiety | 3% | 5% |
| * Patients receiving ZIAGEN 600 mg once daily, experienced a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea compared with patients who received ZIAGEN 300 mg twice daily. Five percent (5%) of patients receiving ZIAGEN 600 mg once daily had severe drug hypersensitivity reactions compared with 2% of patients receiving ZIAGEN 300 mg twice daily. Two percent (2%) of patients receiving ZIAGEN 600 mg once daily had severe diarrhea while none of the patients receiving ZIAGEN 300 mg twice daily had this event. | ||
| † Study CNA30024 was a multi-center, double-blind, controlled study in which 649 HIV-1-infected, therapy-naive adults were randomized and received either ZIAGEN (300 mg twice daily), EPIVIR (150 mg twice daily), and efavirenz (600 mg once daily) or zidovudine (300 mg twice daily), EPIVIR (150 mg twice daily), and efavirenz (600 mg once daily). CNA30024 used double-blind ascertainment of suspected hypersensitivity reactions. During the blinded portion of the study, suspected hypersensitivity to abacavir was reported by investigators in 9% of 324 patients in the abacavir group and 3% of 325 patients in the zidovudine group. | ||
Laboratory Abnormalities:
Laboratory abnormalities observed in clinical studies of ZIAGEN were anemia, neutropenia, liver function test abnormalities, and elevations of CPK, blood glucose, and triglycerides. Additional laboratory abnormalities observed in clinical studies of EPIVIR were thrombocytopenia and elevated levels of bilirubin, amylase, and lipase.
The frequencies of treatment-emergent laboratory abnormalities were comparable between treatment groups in Study CNA30021.
Other Adverse Events:
In addition to adverse reactions listed above, other adverse events observed in the expanded access program for abacavir were pancreatitis and increased GGT.
Observed During Clinical Practice:
The following reactions have been identified during post-approval use of abacavir and lamivudine. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to abacavir and/or lamivudine.
Abacavir:Cardiovascular: Myocardial infarction.
Skin: Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. Because of the overlap of clinical signs and symptoms between hypersensitivity to abacavir and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be discontinued and not restarted in such cases.
There have also been reports of erythema multiforme with abacavir use.
Abacavir and Lamivudine:Body as a Whole: Redistribution/accumulation of body fat.
Digestive: Stomatitis.
Endocrine and Metabolic: Hyperglycemia.
General: Weakness.
Hemic and Lymphatic: Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly.
Hepatic and Pancreatic: Lactic acidosis and hepatic steatosis, pancreatitis, posttreatment exacerbation of hepatitis B.
Hypersensitivity: Sensitization reactions (including anaphylaxis), urticaria.
Musculoskeletal: Muscle weakness, CPK elevation, rhabdomyolysis.
Nervous: Paresthesia, peripheral neuropathy, seizures.
Respiratory: Abnormal breath sounds/wheezing.
Skin: Alopecia, erythema multiforme, Stevens-Johnson syndrome.
TopSide Effects by Body System
Hypersensitivity
Hypersensitivity reactions associated with abacavir therapy have been serious and sometimes fatal. Frequently observed signs and symptoms include, fever, skin rash (maculopapular, urticarial, or variable appearance), nausea, vomiting, diarrhea, abdominal pain, pharyngitis, malaise, fatigue, achiness, dyspnea, and cough. Abacavir should be permanently discontinued as soon as a hypersensitivity reaction is suspected. Severe or fatal hypersensitivity reactions can also occur within hours after restarting abacavir in patients who have no identified history or unrecognized symptoms of this reaction. Other symptoms of abacavir hypersensitivity have included lethargy, myolysis, edema, abnormal chest X-ray (infiltrates), paresthesia, anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, lymphadenopathy, mucous membrane lesions (conjunctivitis and stomatitis), elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia.
Stevens-Johnson syndrome and toxic epidermal necrolysis have also been reported with abacavir (alone or in combination with other drugs). Lamivudine has been associated with angioedema, urticaria, and anaphylactoid reactions.
Abacavir hypersensitivity is a clinical syndrome affecting multiple organs in two or more of the following groups:
(1) fever
(2) rash
(3) gastrointestinal
(4) constitutional
(5) respiratory
A strong predictor of hypersensitivity reaction may be the presence of human leukocyte antigen subtype B*5701 (HLA-B*5701). Analyzing past studies, patients testing positive for HLA-B*5701 had a greater risk (about 70%) of developing hypersensitivity reactions with abacavir, while patients without HLA-B*5701 had a low risk (less than 1%). Prospective screening for HLA-B*5701 may decrease the incidence of abacavir hypersensitivity reactions.
Hepatic
Hepatic side effects have included lactic acidosis, severe hepatomegaly with steatosis, including fatal cases, with the use of nucleoside analogs alone or in combination with other antiretroviral agents. Elevations in hepatic enzymes and bilirubin, and rare cases of hepatic decompensation have also been reported.
Gastrointestinal
Gastrointestinal side effects have included nausea (5%), diarrhea (5%), and abdominal pain/gastritis (4%) with abacavir/lamivudine/efavirenz therapy. Stomatitis and pancreatitis have also been reported with abacavir and/or lamivudine. Pancreatitis has been rarely reported in adults (less than 0.5%), but may be more common in pediatric patients (up to 15% in 2 limited studies) receiving lamivudine.
Dermatologic
Dermatologic side effects associated with abacavir have included rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Sweet's syndrome. Lamivudine has been associated with rash, pruritus, and alopecia.
Hematologic
Hematologic side effects have included aplastic anemia, anemia (pure red cell aplasia and severe progressive anemias), lymphadenopathy, neutropenia, splenomegaly, and thrombocytopenia with abacavir and/or lamivudine. Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen.
Metabolic
Metabolic side effects have included elevations of blood glucose, triglycerides, bilirubin, amylase, and lipase. In addition, redistribution and/or accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance has been observed in patients taking antiretroviral agents. A causal relationship has not been established. The mechanism and long-term effects of these complications have not been determined.
Nervous system
Nervous system side effects have included insomnia (7%), headache/migraine (7%), and dizziness/vertigo (6%) with abacavir/lamivudine/efavirenz combination therapy. Peripheral neuropathy, paresthesia, and seizures have been reported with abacavir and/or lamivudine.
Endocrine
Endocrine side effects associated with lamivudine have included hyperglycemia.
Other
Other side effects have included fatigue/malaise (6%), pyrexia (5%) with abacavir/lamivudine/efavirenz therapy. Weakness has also been reported with abacavir and/or lamivudine.
Musculoskeletal
Musculoskeletal side effects have included muscle weakness, CPK elevations, and rhabdomyolysis with abacavir and/or lamivudine.
Respiratory
Respiratory side effects have included abnormal breath sounds and wheezing with lamivudine.
Psychiatric
Psychiatric side effects have included depression (7%), abnormal dreams (4%), and anxiety (3%) with abacavir/lamivudine/efavirenz therapy.
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