Ziagen Side Effects
Please note - some side effects for Ziagen 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).
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For the consumer For the professional
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Side Effects of Ziagen - for the consumer
Ziagen
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 Ziagen:
Seek medical attention right away if any of these SEVERE side effects occur when using Ziagen:Exhaustion; flushing; general body discomfort; headache; joint pain; lack of energy; loss of appetite; mouth sores; muscle aches; redness of the eyes or swelling of the conjunctiva; severe muscle pain or cramping; sleeplessness; swelling; unusual weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal skin sensations; achiness; chest pain; cough; diarrhea; extreme tiredness; fainting; fever; flu-like illness; generally ill feeling; nausea; severe dizziness; shortness of breath; sore throat; stomach pain; vomiting.
Ziagen Solution
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 Ziagen Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Ziagen Solution:Exhaustion; flushing; general body discomfort; headache; joint pain; lack of energy; loss of appetite; mouth sores; muscle aches; redness of the eyes or swelling of the conjunctiva; severe muscle pain or cramping; sleeplessness; swelling; unusual weakness.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal skin sensations; achiness; chest pain; cough; diarrhea; extreme tiredness; fainting; fever; flu-like illness; generally ill feeling; nausea; severe dizziness; shortness of breath; sore throat; stomach pain; vomiting.
For the professional
Ziagen
Hypersensitivity Reaction
Serious and sometimes
fatal hypersensitivity reactions have been associated with Ziagen (abacavir sulfate). 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 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily compared with zidovudine 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily from CNA30024 are listed in Table 5.
Adverse Reaction |
Ziagen plus Lamivudine plus Efavirenz (n = 324) |
Zidovudine plus Lamivudine plus Efavirenz (n = 325) |
Dreams/sleep disorders |
10% |
10% |
Drug hypersensitivity |
9% |
<1%† |
Headaches/migraine |
7% |
11% |
Nausea |
7% |
11% |
Fatigue/malaise |
7% |
10% |
Diarrhea |
7% |
6% |
Rashes |
6% |
12% |
Abdominal pain/gastritis/ gastrointestinal signs and symptoms |
6% |
8% |
Depressive disorders |
6% |
6% |
Dizziness |
6% |
6% |
Musculoskeletal pain |
6% |
5% |
Bronchitis |
4% |
5% |
Vomiting |
2% |
9% |
* This study 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.
†Ten (3%) cases of suspected drug hypersensitivity were reclassified as not being due to abacavir following unblinding.
Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a ≥5% frequency during therapy with Ziagen 300 mg twice daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily compared with indinavir 800 mg 3 times daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily from CNA3005 are listed in Table 6.
Adverse Reaction |
Ziagen plus Lamivudine/Zidovudine (n = 262) |
Indinavir plus Lamivudine/Zidovudine (n = 264) |
Nausea |
19% |
17% |
Headache |
13% |
9% |
Malaise and fatigue |
12% |
12% |
Nausea and vomiting |
10% |
10% |
Hypersensitivity reaction |
8% |
2% |
Diarrhea |
7% |
5% |
Fever and/or chills |
6% |
3% |
Depressive disorders |
6% |
4% |
Musculoskeletal pain |
5% |
7% |
Skin rashes |
5% |
4% |
Ear/nose/throat infections |
5% |
4% |
Viral respiratory infections |
5% |
5% |
Anxiety |
5% |
3% |
Renal signs/symptoms |
<1% |
5% |
Pain (non-site-specific) |
<1% |
5% |
Five patients receiving Ziagen in Study CNA3005 experienced worsening of pre-existing depression compared to none in the indinavir arm. The background rates of pre-existing depression were similar in the 2 treatment arms.
Ziagen Once Daily versus Ziagen Twice Daily (Study CNA30021)Treatment-emergent clinical adverse reactions (rated by the investigator as at least moderate) 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 from Study CNA30021 were similar. (For hypersensitivity reactions, patients receiving Ziagen once daily showed a rate of 9% in comparison to a rate of 7% for patients receiving Ziagen twice daily.) However, patients receiving Ziagen 600 mg once daily, experienced a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea compared to 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 to 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.
Therapy-Experienced Pediatric Patients
Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a ≥5% frequency during therapy with Ziagen 8 mg/kg twice daily, lamivudine 4 mg/kg twice daily, and zidovudine 180 mg/m2 twice daily compared with lamivudine 4 mg/kg twice daily and zidovudine 180 mg/m2 twice daily from CNA3006 are listed in Table 7.
Adverse Reaction |
Ziagen plus Lamivudine plus Zidovudine (n = 102) |
Lamivudine plus Zidovudine (n = 103) |
Fever and/or chills |
9% |
7% |
Nausea and vomiting |
9% |
2% |
Skin rashes |
7% |
1% |
Ear/nose/throat infections |
5% |
1% |
Pneumonia |
4% |
5% |
Headache |
1% |
5% |
Laboratory Abnormalities
Laboratory abnormalities (Grades 3-4) in therapy-naive adults during therapy with Ziagen 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily compared with zidovudine 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily from CNA30024 are listed in Table 8.
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Grade 3/4 Laboratory Abnormalities |
Ziagen plus Lamivudine plus Efavirenz (n = 324) |
Zidovudine plus Lamivudine plus Efavirenz (n = 325) |
Elevated CPK (>4 X ULN) |
8% |
8% |
Elevated ALT (>5 X ULN) |
6% |
6% |
Elevated AST (>5 X ULN) |
6% |
5% |
Hypertriglyceridemia (>750 mg/dL) |
6% |
5% |
Hyperamylasemia (>2 X ULN) |
4% |
5% |
Neutropenia (ANC <750/mm3) |
2% |
4% |
Anemia (Hgb ≤6.9 gm/dL) |
<1% |
2% |
Thrombocytopenia (Platelets <50,000/mm3) |
1% |
<1% |
Leukopenia (WBC≤1,500/mm3) |
<1% |
2% |
ULN = Upper limit of normal.
n = Number of patients assessed.
Laboratory abnormalities in study CNA3005 are listed in Table 9.
Grade 3/4 Laboratory Abnormalities |
Number of Subjects by Treatment Group |
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Ziagen plus Lamivudine/Zidovudine (n = 262) |
Indinavir plus Lamivudine/Zidovudine (n = 264) |
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Elevated CPK (>4 x ULN) |
18 (7%) |
18 (7%) |
ALT (>5.0 x ULN) |
16 (6%) |
16 (6%) |
Neutropenia (<750/mm3) |
13 (5%) |
13 (5%) |
Hypertriglyceridemia (>750 mg/dL) |
5 (2%) |
3 (1%) |
Hyperamylasemia (>2.0 x ULN) |
5 (2%) |
1 (<1%) |
Hyperglycemia (>13.9 mmol/L) |
2 (<1%) |
2 (<1%) |
Anemia (Hgb ≤6.9 g/dL) |
0 (0%) |
3 (1%) |
ULN = Upper limit of normal.
n = Number of patients assessed.
In a study of therapy-experienced pediatric patients (CNA3006), laboratory abnormalities (anemia, neutropenia, liver function test abnormalities, and CPK elevations) were observed with similar frequencies as in a study of therapy-naive adults (CNA30024). Mild elevations of blood glucose were more frequent in pediatric patients receiving Ziagen (CNA3006) as compared to adult patients (CNA30024).
The frequencies of treatment-emergent laboratory abnormalities were comparable between treatment groups in Study CNA30021.
Other Adverse Events
In addition to adverse reactions in Tables 5, 6, 7, 8, and 9, other adverse events observed in the expanded access program were pancreatitis and increased GGT.
Observed During Clinical Practice
In addition to adverse reactions reported from clinical trials, the following events have been identified during use of abacavir in clinical practice. 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 either their seriousness, frequency of reporting, potential causal connection to abacavir, or a combination of these factors.
Body as a WholeRedistribution/accumulation of body fat.
HepaticLactic acidosis and hepatic steatosis.
SkinSuspected 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.
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Ziagen - Includes detailed dosage instructions.
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