Aptivus Side Effects

Generic Name: tipranavir

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

Aptivus

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 Aptivus:

Cough; diarrhea; headache; nausea; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body fat changes; confusion; dark urine; depression; difficulty urinating; dizziness; excessive hunger, thirst, or urination; fast heartbeat; fever, chills, or sore throat; flu-like symptoms; fruit-like breath odor; itching; joint pain or stiffness; loss of appetite; mental or mood changes; mouth sores or ulcers; muscle pain; numbness or tingling; pale stools; red, blistered, swollen, or peeling skin; severe or persistent nausea; shortness of breath; slurred speech or one-sided weakness; stomach pain or tenderness; throat tightness; unusual bruising or bleeding; unusual drowsiness or tiredness; unusual weakness; vision changes; yellowing of the skin or eyes.

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.

Aptivus 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 Aptivus Solution:

Cough; diarrhea; headache; nausea; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body fat changes; confusion; dark urine; depression; difficulty urinating; dizziness; excessive hunger, thirst, or urination; fast heartbeat; fever, chills, or sore throat; flu-like symptoms; fruit-like breath odor; itching; joint pain or stiffness; loss of appetite; mental or mood changes; mouth sores or ulcers; muscle pain; numbness or tingling; pale stools; red, blistered, swollen, or peeling skin; severe or persistent nausea; slurred speech or one-sided weakness; stomach pain or tenderness; throat tightness; unusual bruising or bleeding; unusual drowsiness or tiredness; unusual weakness; vision changes; yellowing of the skin or eyes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Side Effects by Body System - for Healthcare Professionals

General

The most frequent adverse effects reported in clinical trials with tipranavir-ritonavir were diarrhea, nausea, fatigue, headache, vomiting, pyrexia, and abdominal pain. Treatment was discontinued due to side effects in 13.3% of patients in the tipranavir-ritonavir arm and 10.8% of patients in the comparator arm. The side effects reported below are from clinical trials with tipranavir 500 mg-ritonavir 200 mg twice daily plus an optimized background regimen.

Dermatologic

Dermatologic side effects have included rash (3.1%), and exanthem and pruritus in less than 2% of subjects. Rash (including urticarial rash, maculopapular rash, and possible photosensitivity) has been reported in 8% of males and 10% of females receiving tipranavir-ritonavir. Rash in conjunction with joint pain or stiffness, throat tightness, and generalized pruritus and cases of severe rash with myalgia, fever, erythema, desquamation, and mucosal erosions have been reported.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (15%), nausea (8.5%), vomiting (5.9%), abdominal pain (4.4%), and upper abdominal pain (1.5%). Abdominal distension, dyspepsia, flatulence, gastroesophageal reflux disease, and pancreatitis have been reported in less than 2% of subjects.

Hematologic

Hematologic side effects have included anemia (3.3%), neutropenia (2%), thrombocytopenia (less than 2%), and decreases in white blood cell counts (Grade 3: 5.4%; Grade 4: 0.3%).

Hematologic side effects associated with protease inhibitors have included spontaneous bleeding in patients with hemophilia A and B. In many of the reported cases, treatment with protease inhibitors was continued or restarted and some patients required additional factor VIII. A causal relationship between protease inhibitor therapy and these episodes has not been established.

Hepatic

Hepatic disorders have included hepatitis, hepatic failure, hyperbilirubinemia, cytolytic hepatitis, toxic hepatitis, hepatic steatosis, increased hepatic transaminases, and abnormal liver function tests in less than 2% of subjects. At least one case of porphyria cutanea tarda has been reported.

Hypersensitivity

Hypersensitivity reactions (not specified) have been reported in less than 2% of subjects.

Immunologic

Immunologic side effects have included reactivation of herpes simplex and varicella zoster in less than 2% of subjects.

Metabolic

Metabolic side effects have included decreased weight (3.1%) and lipase elevations, anorexia, decreased appetite, dehydration, diabetes mellitus, facial wasting, hyperglycemia, mitochondrial toxicity, lipoatrophy, lipohypertrophy, and acquired lipodystrophy in less than 2% of subjects. Laboratory abnormalities reported in patients in 48-week trials have included amylase elevations (Grade 3: greater than 2.5 times ULN, 5.7%; Grade 4: greater than 5 times ULN, 0.3%), ALT elevations (Grade 2: 2.5 to 5 times ULN, 14.9%; Grade 3: 5 to 10 times ULN, 5.6%; Grade 4: greater than 10 times ULN, 4.1%), AST elevations (Grade 2: 2.5 to 5 times ULN, 9.9%; Grade 3: 5 to 10 times ULN, 4.5%; Grade 4: greater than 10 times ULN, 1.6%), ALT and/or AST elevations (Grade 2 to 4: greater than 2.5 times ULN, 26%), cholesterol elevations (Grade 2: 300 to 400 mg/dL, 15.6%; Grade 3: 400 to 500 mg/dL, 3.3%; Grade 4: greater than 500 mg/dL, 0.9%), and triglyceride elevations (Grade 2: 400 to 750 mg/dL, 35.9%; Grade 3: 750 to 1200 mg/dL; 16.9%, Grade 4: greater than 1200 mg/dL, 8%). In 96-week clinical trials, 32.1% of patients developed Grade 2 to 4 ALT and/or AST elevations.

Musculoskeletal

Musculoskeletal side effects have included myalgia (2.3%) and muscle cramps (less than 2%).

Nervous system

Nervous system side effects have included headache (5.2%), and dizziness, peripheral neuropathy, and somnolence in less than 2% of patients. Other side effects have included fatal and nonfatal intracranial hemorrhage when coadministered with 200 mg of ritonavir. Cerebrovascular accident has also been reported.

Other

Other side effects have included pyrexia (7.5%), fatigue (5.7%), asthenia (1.5%), influenza-like illness (less than 2%), malaise (less than 2%), and sepsis.

Psychiatric

Psychiatric side effects have included depression (2%), insomnia (1.7%), and sleep disorder (less than 2%).

Respiratory

Respiratory side effects have included bronchitis (2.9%), dyspnea (3.1%), cough (0.8%), nasopharyngitis, upper respiratory tract infection, and pneumonia.

Renal

Renal side effects have included renal insufficiency in less than 2% of patients.

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.