Delavirdine Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 25, 2023.

Applies to delavirdine: oral tablet.

Serious side effects of delavirdine

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 side effects

• skin rash (severe) with itching

Less common side effects

• skin rash with symptoms such as fever, blistering, oral lesions, conjunctivitis, swelling, muscle aches, or joint aches

Rare side effects

• difficulty in breathing

Incidence unknown

• agitation
• back, leg, or stomach pains
• bleeding gums
• chills
• coma
• confusion
• dark urine
• decreased urine output
• depression
• difficulty breathing
• dizziness
• fatigue
• fever
• general body swelling
• headache
• hostility
• irritability
• lethargy
• loss of appetite
• muscle twitching
• nausea
• nosebleeds
• pale skin
• rapid weight gain
• seizures (convulsions)
• sore throat
• stupor
• swelling of face, ankles, or hands
• unusual tiredness or weakness
• vomiting
• yellowing of the eyes or skin

Other side effects of delavirdine

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 side effects

• body aches or pain
• cough
• diarrhea
• discouragement
• ear congestion
• fear
• 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
• nervousness
• pain, localized
• pain or tenderness around eyes and cheekbones
• runny nose
• shivering
• shortness of breath
• sneezing
• sweating
• tightness in chest
• tiredness
• trouble concentrating
• trouble sleeping
• wheezing

Less common side effects

• abdominal pain, generalized
• dryness or soreness of throat
• hoarseness
• sleeplessness
• tender, swollen glands in neck
• trouble in swallowing
• unable to sleep
• voice changes

For healthcare professionals

Applies to delavirdine: oral tablet.

General adverse events

In clinical trials with this drug alone or with other antiretroviral agents, most side effects were of mild or moderate severity. The most common drug-related side effect was skin rash.^[Ref]

Dermatologic

• Very common (10% or more): Rash (included rash, maculopapular rash, urticaria; 35.4%), rashes (up to 19.5%), grade 1 rash (erythema, pruritus; 16.7%), grade 2 rash (diffuse maculopapular rash, dry desquamation; 14.3%)
• Common (1% to 10%): Grade 3 rash (vesiculation, moist desquamation, ulceration)
• Frequency not reported: Epidermal cyst, sebaceous cyst, angioedema, dermal leukocytoclastic vasculitis, dermatitis, desquamation, diaphoresis, discolored skin, dry skin, erythema, erythema multiforme, folliculitis, fungal dermatitis, hair loss, herpes zoster/simplex, nail disorder, petechiae, non-application site pruritus, seborrhea, skin hypertrophy, skin disorder, skin nodule, Stevens-Johnson syndrome, urticaria, vesiculobullous rash, wart^[Ref]

Most drug-related rashes occurred within 1 to 3 weeks after starting therapy. In most cases, rash duration was less than 2 weeks and did not require dose reduction or discontinuation of this drug. Most patients resumed therapy after rechallenge with this drug when treatment was interrupted due to rash. The distribution of rash was primarily on the upper body and proximal arms, with decreasing severity of lesions on the neck and face, and progressively less on the remaining trunk and limbs.

Erythema multiforme and Stevens-Johnson syndrome occurred rarely in clinical trials and typically resolved when this drug was discontinued.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 20.3%)
• Common (1% to 10%): Vomiting, diarrhea, generalized abdominal pain, increased amylase
• Frequency not reported: Abdominal cramps, abdominal distention, localized abdominal pain, lip edema, bloody stool, colitis, constipation, Clostridium difficile associated diarrhea, diverticulitis, dry mouth, dyspepsia, dysphagia, enteritis (at all levels), eructation, fecal incontinence, flatulence, gagging, gastroenteritis, gastroesophageal reflux, gastrointestinal bleeding, gastrointestinal disorder, gingivitis, gum hemorrhage, increased lipase, increased saliva, mouth/tongue ulcers/inflammation, oral/enteric moniliasis, pancreatitis, rectal disorder, sialadenitis, tooth abscess, toothache, gastritis^[Ref]

Increased amylase (greater than 2 times the upper limit of normal [2 x ULN]) has been reported in up to 3.5% of patients.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 16.8%)
• Frequency not reported: Abnormal coordination, amnesia, cognitive impairment, confusion, disorientation, dizziness, hyperesthesia, hyperreflexia, hypertonia, hypesthesia, impaired concentration, migraine, neuropathy, nystagmus, paralysis, parosmia, restlessness, sleep cycle disorder, somnolence, taste perversion, tinnitus, tingling, tremor, vertigo

Other

• Very common (10% or more): Asthenia/fatigue (up to 16%)
• Common (1% to 10%): Fever, influenza syndrome, localized pain
• Frequency not reported: Abscess, chills, generalized/localized edema, infection, viral infection, malaise, Mycobacterium tuberculosis infection, increased thirst, increased serum alkaline phosphatase, increased/decreased weight, weakness, ear pain, otitis media^[Ref]

Psychiatric

• Very common (10% or more): Depressive symptoms (up to 12.6%)
• Common (1% to 10%): Anxiety, insomnia
• Frequency not reported: Agitation, change in dreams, decreased libido, emotional lability, euphoria, hallucination, manic symptoms, nervousness, paranoid symptoms

Hematologic

• Common (1% to 10%): Decreased neutrophils, decreased hemoglobin, prolonged prothrombin time, increased activated partial thromboplastin
• Frequency not reported: Adenopathy, bruising, eosinophilia, granulocytosis, leukopenia, pancytopenia, purpura, spleen disorder, thrombocytopenia
• Postmarketing reports: Hemolytic anemia^[Ref]

Decreased neutrophils (less than 750/mm3), decreased hemoglobin (less than 7 mg/dL), prolonged prothrombin time (greater than 1.5 x ULN), and increased activated partial thromboplastin (greater than 2.33 x ULN) have been reported in up to 7.6%, up to 2.9%, up to 2.4%, and up to 2.4% of patients, respectively.^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory infection, sinusitis, bronchitis, cough, pharyngitis
• Frequency not reported: Chest congestion, dyspnea, epistaxis, hiccups, laryngismus, pneumonia, rhinitis^[Ref]

Hepatic

• Common (1% to 10%): Increased ALT, increased AST, increased bilirubin, increased GGT
• Frequency not reported: Hepatomegaly, jaundice, bilirubinemia, nonspecific hepatitis
• Postmarketing reports: Hepatic failure^[Ref]

Increased ALT (greater than 5 x ULN), AST (greater than 5 x ULN), bilirubin (greater than 2.5 x ULN), and GGT (greater than 5 x ULN) have been reported in up to 5.1%, up to 3.4%, up to 2.5%, and up to 1.8% of patients, respectively.^[Ref]

Metabolic

• Common (1% to 10%): Hyperglycemia/hypoglycemia
• Frequency not reported: Alcohol intolerance, anorexia, increased/decreased appetite, hyperkalemia, hypertriglyceridemia, hyperuricemia, hypocalcemia, hyponatremia, hypophosphatemia, redistribution/accumulation of body fat

Antiretroviral therapy:

• Frequency not reported: Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"^[Ref]

Decreased or increased glucose (hypoglycemia [less than 40 mg/dL] or hyperglycemia [greater than 250 mg/dL]) has been reported in up to 1.7% of patients.^[Ref]

Cardiovascular

• Frequency not reported: Abnormal cardiac rate and rhythm, cardiac insufficiency, cardiomyopathy, hypertension, pallor, peripheral vascular disorder, postural hypotension

Renal

• Frequency not reported: Increased serum creatinine, renal calculi, renal pain
• Postmarketing reports: Acute renal failure

Genitourinary

• Frequency not reported: Amenorrhea, breast enlargement, chromaturia, epididymitis, hematuria, hemospermia, impaired urination, impotence, metrorrhagia, nocturia, polyuria, proteinuria, testicular pain, urinary tract infection, vaginal moniliasis^[Ref]

Musculoskeletal

• Frequency not reported: Arthralgia/arthritis of single and multiple joints, bone disorder, bone pain, myalgia, neck rigidity, tendon disorder, tenosynovitis, tetany, muscle cramp
• Postmarketing reports: Rhabdomyolysis^[Ref]

Ocular

• Frequency not reported: Blepharitis, blurred vision, conjunctivitis, diplopia, dry eyes, photophobia

Immunologic

• Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Hypersensitivity

• Frequency not reported: Allergic reaction

Further information

Delavirdine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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