"Current prevention strategies have reduced the incidence of HIV worldwide, but that decline has slowed in recent years. We need new prevention strategies if we are to realize President Obama's goal of an AIDS-free generation. Targeting people who"...
Hivid Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Hivid in Detail - Patient Information: Side Effects
Stop using zalcitabine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these other serious side effects:
- liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, and fast or uneven heart rate;
- pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
- peripheral neuropathy - numbness, tingling, or pain in your hands or feet;
- easy bruising or bleeding, unusual weakness, pale skin;
- white patches or sores inside your mouth or on your lips;
- seizure (convulsions);
- fever, chills, body aches, flu symptoms; or
- any other signs of new infection.
Less serious side effects may be more likely to occur, such as:
- mild nausea, vomiting, stomach pain, diarrhea, constipation;
- headache, tired feeling;
- skin rash; or
- changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Read the entire detailed patient monograph for Hivid (Zalcitabine) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Hivid FDA Prescribing Information: Side Effects
Tables 2 and 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 (zalcitabine) vs didanosine (ddI), and the comparative combination trial (ACTG 175) of zidovudine (ZDV) monotherapy vs HIVID (zalcitabine) 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.
Table 2. Percentage of Patients With Clinical Adverse Experience
≥ Grade 3*† in ≥ 1% of Patients Receiving HIVID (zalcitabine)
|CPCRA 002* ZDV Intolerantor Failure||ACTG 175‡ ZDV Naive/Experienced|
|HIVID 0.750 mg q8h
|ddI 250 mg q12h
|ZDV 200 mg q8h
|HIVID + ZDV 0.750 mg q8h + 200 mg q8h
|Body System/Adverse Event|
|Abnormal Hepatic Function||8.9||7.0|||||||||
|Metabolic and Nutrition|
|* Grade 2 Adverse Events possibly or probably
related to treatment or unassessable were included if study drug dosage
was changed or interrupted.
† Grade 3 severity: event possible hospitalization.
Grade 4 severity: completely disabling, unable to care for self, requiring active medical intervention, probable hospitalization or hospice care.
‡ All relationships.
§ Adverse experiences were combined to form this category.
|| See Table 3.
¶ CPCRA 002 included patients who were dose-adjusted for Grade 2 events; ACTG 175 required dose adjustment for Grade 2 peripheral neuropathy but recorded only Grade 3 events.
Table 3. Percentage of Patients With Laboratory Abnormalities
- Protocol Grade 3/4
|CPCRA 002* ZDV Intolerant or Failure||ACTG 175 ZDV Naive/Experienced|
|HIVID 0.750 mg q8h
|ddI 250 mg q12h
|ZDV 200 mg q8h
|HIVID (zalcitabine) +ZDV
0.750 mg q8h+200 mg q8h
|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 x ULN)||0.8||0.0||5.8||5.7|
|ALT (SGPT) (>5 x ULN)||N/A||N/A||3.6||5.0|
|AST (SGOT) (>5 x ULN)||7.6||5.7||2.9||4.1|
|Bilirubin (>2.5 x ULN)||0.8||0.9||0.5||1.0|
|GGT (>5 x ULN)||N/A||N/A||0.5||1.0|
|Amylase (>2 x ULN)||5.1||3.9||1.0||1.5|
|Hyperglycemia* (>250 mg/dL)||0.0||1.7||0.8||2.0|
|*Grade 3 or higher reported for CPCRA 002.
N/A Not available.
Additional clinical adverse experiences associated with HIVID (zalcitabine) 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 (see WARNINGS), malaise, night sweats, pain, pelvic/groin pain, rigors, redistribution/accumulation of body fat (see PRECAUTIONS: Fat Redistribution).
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.
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.
Read the entire FDA prescribing information for Hivid (Zalcitabine) »
Additional Hivid Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get breaking medical news.