Hivid Side Effects
Please note - some side effects for Hivid 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 Hivid - for the consumer
Hivid
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 Hivid:
Seek medical attention right away if any of these SEVERE side effects occur when using Hivid:Constipation; diarrhea; fatigue; headache; itching; loss of appetite; nausea; shift in body fat to stomach and upper back; tiredness.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions; fast, shallow breathing; feeling cold; heart problems; lactic acid imbalance (slow or irregular heartbeat; dizziness; lightheadedness); liver inflammation (liver tenderness; weakness; fatigue); numbness, tingling, burning, or sharp shooting pains in arms, hands, legs, and feet; pain on swallowing; persistent or severe nausea; severe muscle pain or cramping; sores in mouth or throat; stomach pain; swelling of the hands or feet; vomiting; weakness or exhaustion.
For the professional
Hivid
Table 2 and Table 3 summarize the clinical adverse events and laboratory abnormalities, respectively, that occurred in≥1% of patients in the comparative monotherapy trial (CPCRA 002) of Hivid vs didanosine (ddI), and the comparative combination trial (ACTG 175) of zidovudine (ZDV) monotherapy vs Hivid and zidovudine combination therapy, respectively. Other studies have found a higher or lower incidence of adverse experiences depending upon disease status, generally being lower in patients with less advanced disease.
| CPCRA 002* ZDV Intolerant or Failure |
ACTG 175‡ ZDV Naive/Experienced |
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|---|---|---|---|---|
| Hivid 0.750 mg q8h |
ddI 250 mg q12h |
ZDV 200 mg q8h |
Hivid+ZDV 0.750 mg q8h +200 mg q8h |
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| n=237 | n=230 | n=619 | n=615 | |
| Body System/Adverse Event | ||||
| ||||
| Systemic | ||||
| Fatigue | 3.8 | 2.6 | 2.7 | 2.3 |
| Headache | 2.1 | 1.3 | 2.4 | 2.6 |
| Fever | 1.7 | 0.4 | 2.7 | 2.9 |
| Gastrointestinal | ||||
| Abdominal Pain | 3.0 | 7.0 | 2.3 | 1.8 |
| Oral Lesions/Stomatitis§ | 3.0 | 0.0 | 0.6 | 1.5 |
| Vomiting/Nausea§ | 3.4 | 7.0 | 4.9 | 2.1 |
| Diarrhea/Constipation§ | 2.5 | 17.4 | 2.9 | 1.0 |
| Hepatic | ||||
| Abnormal Hepatic Function | 8.9 | 7.0 | ¶ | ¶ |
| Neurological | ||||
| Convulsions | 1.3 | 2.2 | ||
| Peripheral Neuropathy# | 28.3 | 13.0 | 3.1 | 3.3 |
| Skin | ||||
| Rash/Pruritus/Urticaria | 3.4 | 3.9 | 1.8 | 1.6 |
| Metabolic and Nutrition | ||||
| Pancreatitis | 0.0 | 1.7 | 0.2 | 0.5 |
| Psychological | ||||
| Depression | 0.4 | 0.0 | 1.1 | 1.8 |
| Musculoskeletal | ||||
| Painful/Swollen Joints | 0.4 | 0.0 | 0.3 | 1.0 |
| CPCRA 002* ZDV Intolerant or Failure |
ACTG 175 ZDV Naive/Experienced |
|||
|---|---|---|---|---|
| Hivid 0.750 mg q8h n=237 |
ddI 250 mg q12h n=230 |
ZDV 200 mg q8h n=619 |
Hivid+ZDV 0.750 mg q8h +200 mg q8h n=615 |
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| Laboratory Abnormality | ||||
| Anemia (<7.5 gm/dL) | 8.4 | 7.4 | 1.8 | 3.1 |
| Leukopenia (<1500 cells/mm3) | 13.1 | 9.6 | N/A† | N/A† |
| Eosinophilia (>1000 cells/mm3 or 25%) |
2.5 | 1.7 | N/A† | N/A† |
| Neutropenia (<750 cells/mm3) | 16.9 | 11.7 | 1.9 | 4.2 |
| Thrombocytopenia (<50,000 cells/mm3) |
1.3 | 4.8 | 1.1 | 1.8 |
| CPK Elevation* (>4× ULN) | 0.8 | 0.0 | 5.8 | 5.7 |
| ALT (SGPT) (>5 × ULN) | N/A† | N/A† | 3.6 | 5.0 |
| AST (SGOT) (>5 × ULN) | 7.6 | 5.7 | 2.9 | 4.1 |
| Bilirubin (>2.5 × ULN) | 0.8 | 0.9 | 0.5 | 1.0 |
| GGT (>5 × ULN) | N/A† | N/A† | 0.5 | 1.0 |
| Amylase (>2 × ULN) | 5.1 | 3.9 | 1.0 | 1.5 |
| Hyperglycemia* (>250 mg/dL) | 0.0 | 1.7 | 0.8 | 2.0 |
Additional clinical adverse experiences associated with Hivid that occurred in <1% of patients in CPCRA 002 (at least possibly related, Grade 3 or higher), ACTG 175 (any relationship, Grade 3/4) or in other clinical studies are listed below by body system. Several of these events occurred in slightly higher rates in other studies. The incidence of adverse experiences varied in different studies, generally being lower in patients with less-advanced disease.
Body as a Whole: abnormal weight loss, asthenia, cachexia, chest tightness or pain, chills, cutaneous/allergic reaction, debilitation, difficulty moving, dry eyes/mouth, edema, facial pain or swelling, flank pain, flushing, increased sweating, lymphadenopathy, hypersensitivity reactions , malaise, night sweats, pain, pelvic/groin pain, rigors, redistribution/accumulation of body fat.
Cardiovascular: abnormal cardiac movement, arrhythmia, atrial fibrillation, cardiac failure, cardiac dysrhythmias, cardiomyopathy, heart racing, hypertension, palpitation, subarachnoid hemorrhage, syncope, tachycardia, ventricular ectopy.
Endocrine/Metabolic: abnormal triglycerides, abnormal lipase, altered serum glucose, decreased bicarbonate, diabetes mellitus, glycosuria, gout, hot flushes, hypercalcemia, hyperkalemia, hyperlipemia, hypernatremia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, increased nonprotein nitrogen, lactic acidosis.
Gastrointestinal: abdominal bloating or cramps, acute pancreatitis, anal/rectal pain, anorexia, bleeding gums, bloody or black stools, colitis, dental abscess, dry mouth, dyspepsia, dysphagia, enlarged abdomen, epigastric pain, eructation, esophageal pain, esophageal ulcers, esophagitis, flatulence, gagging with pills, gastritis, gastrointestinal hemorrhage, gingivitis, glossitis, gum disorder, heartburn, hemorrhagic pancreatitis, hemorrhoids, increased saliva, left quadrant pain, melena, mouth lesion, odynophagia, painful sore gums, painful swallowing, pancreatitis, rectal hemorrhage, rectal mass, rectal ulcers, salivary gland enlargement, sore tongue, sore throat, tongue disorder, tongue ulcer, toothache, unformed/loose stools, vomiting.
Hematologic: absolute neutrophil count alteration, anemia, epistaxis, decreased hematocrit, granulocytosis, hemoglobinemia, leukopenia, neutrophilia, platelet alteration, purpura, thrombus, unspecified hematologic toxicity, white blood cell alteration.
Hepatic: abnormal lactate dehydrogenase, bilirubinemia, cholecystitis, decreased alkaline phosphatase, hepatitis, hepatocellular damage, hepatomegaly, increased alkaline phosphatase, jaundice.
Musculoskeletal: arthralgia, arthritis, arthropathy, arthrosis, back pain, backache, bone pains/aches, bursitis, cold extremities, extremity pain, joint inflammation, leg cramps, muscle aches, muscle weakness, muscle disorder, muscle stiffness, muscle cramps, myalgia, myopathy, myositis, neck pain, rib pain, stiff neck.
Neurological: abnormal coordination, aphasia, ataxia, Bell's palsy, confusion, decreased concentration, decreased neurological function, disequilibrium, dizziness, dysphonia, facial nerve palsy, focal motor seizures, grand mal seizure, hyperkinesia, hypertonia, hypokinesia, memory loss, migraine, neuralgia, neuritis, paralysis, seizures, speech disorder, status epilepticus, stupor, tremor, twitch, vertigo.
Psychological: acute psychotic disorder, acute stress reaction, agitation, amnesia, anxiety, confusion, decreased motivation, decreased sexual desire, depersonalization, emotional lability, euphoria, hallucination, impaired concentration, insomnia, manic reaction, mood swings, nervousness, paranoid state, somnolence, suicide attempt, dementia.
Respiratory: acute nasopharyngitis, chest congestion, coughing, cyanosis, difficulty breathing, dry nasal mucosa, dyspnea, flu-like symptoms, hemoptysis, nasal discharge, pharyngitis, rales/rhonchi, respiratory distress, sinus congestion, sinus pain, sinusitis, wheezing.
Skin: acne, alopecia, bullous eruptions, carbuncle/furuncle, cellulitis, cold sore, dermatitis, dry skin, dry rash desquamation, erythematous rash, exfoliative dermatitis, finger inflammation, follicular rash, impetigo, infection, itchy rash, lip blisters/lesions, macular/papular rash, maculopapular rash, moniliasis, mucocutaneous/skin disorder, nail disorder, photosensitivity reaction, pruritic disorder, pruritus, skin disorder, skin lesions, skin fissure, skin ulcer, urticaria.
Special Senses: abnormal vision, blurred vision, burning eyes, decreased taste, decreased vision, ear pain/problem, ear blockage, eye abnormality, eye inflammation, eye itching, eye pain, eye irritation, eye redness, eye hemorrhage, fluid in ears, hearing loss, increased tears, loss of taste, mucopurulent conjunctivitis, parosmia, photophobia, smell dysfunction, taste perversion, tinnitus, unequal-sized pupils, xerophthalmia, yellow sclera.
Urogenital: abnormal renal function, acute renal failure, albuminuria, bladder pain, dysuria, frequent urination, genital lesion/ulcer, increased blood urea nitrogen, increased creatinine, micturition frequency, nocturia, painful penis sore, pain on urination, penile edema, polyuria, renal cyst, renal calculus, testicular swelling, toxic nephropathy, urinary retention, vaginal itch, vaginal ulcer, vaginal pain, vaginal/cervix disorder, vaginal discharge.
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