Delavirdine Side Effects
Some side effects of delavirdine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to delavirdine: oral tablet
Along with its needed effects, delavirdine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur while taking delavirdine:More common
- Skin rash (severe) with itching
- Skin rash with symptoms such as fever, blistering, oral lesions, conjunctivitis, swelling, muscle aches, or joint aches
- Difficulty in breathing
- back, leg, or stomach pains
- bleeding gums
- dark urine
- decreased urine output
- difficulty breathing
- general body swelling
- loss of appetite
- muscle twitching
- pale skin
- rapid weight gain
- seizures (convulsions)
- sore throat
- swelling of face, ankles, or hands
- unusual tiredness or weakness
- yellowing of the eyes or skin
Some side effects of delavirdine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Body aches or pain
- ear congestion
- feeling sad or empty
- general feeling of discomfort or illness
- joint pain
- lack or loss of strength
- loss of interest or pleasure
- loss of voice
- muscle aches and pains
- nasal congestion
- pain, localized
- pain or tenderness around eyes and cheekbones
- runny nose
- shortness of breath
- tightness in chest
- trouble concentrating
- trouble sleeping
- Abdominal pain, generalized
- dryness or soreness of throat
- tender, swollen glands in neck
- trouble in swallowing
- unable to sleep
- voice changes
For Healthcare Professionals
Applies to delavirdine: oral tablet
The majority of adverse effects were mild to moderate in intensity during clinical trials with delavirdine alone or with other antiretroviral agents. Dermatologic effects, primarily rash, are the most common adverse effects observed and have occurred in approximately 18% of patients enrolled in Phase I and Phase II clinical trials assessing combination therapy with delavirdine. Rash has reportedly appeared in up to 44% of patients in other clinical trials. In Phase I and II trials, delavirdine treatment was discontinued in 4.3% of treated patients secondary to drug rash and severe rash occurred in 3.6% of patients.
Rash (typically occurring on the upper body and proximal arms) presents within 1 to 3 weeks of therapy as diffuse, maculopapular, erythematous, and often pruritic. It occurs more frequently in patients with lower CD4 counts. Dose titration does not significantly reduce the incidence of rash and, furthermore, is not recommended due to the rapid development of delavirdine resistant HIV strains when subpotent dosages are administered. Most cases resolve within 2 weeks and do not require discontinuation of delavirdine. Symptomatic treatment such as diphenhydramine or topical corticosteroids has provided relief in some cases.
Dermatologic side effects have included grade 1 rash (erythema, pruritus; 16.7%), grade 2 rash (diffuse maculopapular rash, dry desquamation; 14.3%), and grade 3 rash (vesiculation, moist desquamation, ulceration; 4.4%). During clinical trials of delavirdine with other antiretroviral agents, rashes (13.4% to 19.5%), epidermal cyst, sebaceous cyst, angioedema, dermal leukocytoclastic vasculitis, dermatitis, desquamation, diaphoresis, discolored skin, dry skin, erythema, folliculitis, fungal dermatitis, hair loss, herpes zoster or simplex, nail disorder, petechiae, non-application site pruritus, seborrhea, skin hypertrophy, skin disorder, skin nodule, urticaria, vesiculobullous rash, and wart have been reported. Erythema multiforme and Stevens-Johnson syndrome occurred rarely and typically resolved with the discontinuation of delavirdine.
Gastrointestinal side effects have included nausea (14.7% to 20.3%), vomiting (2.5% to 6.5%), diarrhea (2.4% to 5.9%), and generalized abdominal pain (2.4% to 5%) during clinical trials of delavirdine with other antiretroviral agents. Abdominal cramps, abdominal distention, localized abdominal pain, anorexia, constipation, gastritis, gastroesophageal reflux, bloody stool, colitis, increased or decreased appetite, Clostridium difficile associated diarrhea, diverticulitis, dry mouth, dyspepsia, dysphagia, all levels of enteritis, eructation, fecal incontinence, flatulence, gagging, gastroenteritis, gastrointestinal bleeding, gastrointestinal disorder, gingivitis, gum hemorrhage, increased saliva, increased thirst, ulcers or inflammation of the mouth or tongue, oral/enteric moniliasis, rectal disorder, sialadenitis, tooth abscess, toothache, and taste perversion have also been reported.
Other side effects have included asthenia/fatigue (5.3% to 16%), fever (1.6% to 7.1%), flu syndrome (2.4% to 7.3%), and localized pain (1.8% to 5.7%) during clinical trials of delavirdine with other antiretroviral agents. Abscess, chills, generalized or localized edema, infection, viral infection, lip edema, malaise, Mycobacterium tuberculosis infection, neck rigidity, ear pain, parosmia, otitis media, and tinnitus have also been reported.
Hematologic side effects have included adenopathy, bruising, eosinophilia, granulocytosis, leukopenia, pancytopenia, purpura, spleen disorder, thrombocytopenia, prolonged prothrombin time (greater than 1.5 times ULN), decreased hemoglobin (less than 7 mg/dL) and neutrophils (less than 750/mm3), and increased activated partial thromboplastin (greater than 2.33 times ULN) during clinical trials of delavirdine with other antiretroviral agents. Hemolytic anemia has been reported during postmarketing experience.
Respiratory side effects have included upper respiratory infection (4.7% to 7.6%), sinusitis (1.2% to 7.3%), bronchitis (3.5% to 6.7%), cough (3.5% to 5%), pharyngitis (1.6% to 5%), chest congestion, dyspnea, epistaxis, hiccups, laryngismus, pneumonia, and rhinitis during clinical trials of delavirdine with other antiretroviral agents.
Hepatic side effects have included increased alanine transaminase (ALT/SGPT; greater than 5 times ULN), aspartate transaminase (AST/SGOT; greater than 5 times ULN), gamma glutamyl transferase (GGT; greater than 5 times ULN), and bilirubin (greater than 2.5 times ULN), hepatomegaly, jaundice, nonspecific hepatitis, and pancreatitis during clinical trials of delavirdine with other antiretroviral agents. Hepatic failure has been reported during postmarketing experience.
Metabolic side effects have included alcohol intolerance, increased amylase (greater than 2 times ULN), bilirubinemia, hyperglycemia (greater than 250 mg/dL), hypoglycemia (less than 40 mg/dL), hyperkalemia, hypertriglyceridemia, hyperuricemia, hypocalcemia, hyponatremia, hypophosphatemia, increased lipase, increased serum alkaline phosphatase, increased serum creatinine, and increased or decreased weight during clinical trials of delavirdine with other antiretroviral agents. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy.
Psychiatric side effects have included depressive symptoms (4.9% to 12.6%), anxiety (2.4% to 6.7%), insomnia (1.2% to 5%), decreased libido, euphoria, hallucination, paranoid symptoms, nervousness, manic symptoms, and emotional lability during clinical trials of delavirdine with other antiretroviral agents.
Nervous system side effects have included headache (11.2% to 16.8%), abnormal coordination, agitation, amnesia, change in dreams, cognitive impairment, confusion, disorientation, dizziness, hyperesthesia, hyperreflexia, hypertonia, hypesthesia, impaired concentration, neuropathy, nystagmus, paralysis, restlessness, sleep cycle disorder, somnolence, tingling, tremor, vertigo, and weakness during clinical trials of delavirdine with other antiretroviral agents.
Cardiovascular side effects have included abnormal cardiac rate and rhythm, cardiac insufficiency, cardiomyopathy, hypertension, migraine, pallor, peripheral vascular disorder, and postural hypotension during clinical trials of delavirdine with other antiretroviral agents.
Renal side effects have included renal calculi and renal pain during clinical trials of delavirdine with other antiretroviral agents. Acute renal failure has been reported during postmarketing experience.
Ocular side effects have included blepharitis, blurred vision, conjunctivitis, diplopia, dry eyes, and photophobia during clinical trials of delavirdine with other antiretroviral agents.
Musculoskeletal side effects have included arthralgia or arthritis of single and multiple joints, bone disorder, bone pain, myalgia, tendon disorder, tenosynovitis, tetany, and muscle cramp during clinical trials of delavirdine with other antiretroviral agents. Rhabdomyolysis has been reported during postmarketing experience.
Genitourinary side effects have included amenorrhea, breast enlargement, epididymitis, hemospermia, impotence, metrorrhagia, testicular pain, vaginal moniliasis, hematuria, chromaturia, impaired urination, nocturia, polyuria, proteinuria, and urinary tract infection during clinical trials of delavirdine with other antiretroviral agents.
Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.
Hypersensitivity side effects have included allergic reaction during clinical trials of delavirdine with other antiretroviral agents.
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