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Delavirdine Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 4, 2021.

Summary

Commonly reported side effects of delavirdine include: skin rash and nausea. Other side effects include: diarrhea, fatigue, headache, increased serum alanine aminotransferase, and increased serum aspartate aminotransferase. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to delavirdine: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • A burning, numbness, or tingling feeling that is not normal.
  • Not able to pass urine or change in how much urine is passed.
  • Feeling confused.
  • Change in balance.
  • A heartbeat that does not feel normal.
  • Hallucinations (seeing or hearing things that are not there).
  • Memory problems or loss.
  • Mood changes.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Pale skin.
  • Any unexplained bruising or bleeding.
  • Feeling very tired or weak.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Change in body fat.
  • Severe diarrhea.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Not able to control eye movements.
  • Muscle or joint pain.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Upset stomach or throwing up.
  • Diarrhea.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to delavirdine: oral tablet

General

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

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]

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]

Metabolic

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]

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]

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

More about delavirdine

Patient resources

Other brands

Rescriptor

Related treatment guides

References

1. "Product Information. Rescriptor (delavirdine)." Pharmacia and Upjohn (2001):

2. Bellman PC "Clinical experience with adding delavirdine to combination therapy in patients in whom multiple antiretroviral treatment including protease inhibitors has failed." AIDS 12 (1998): 1333-40

3. Conway B "Initial therapy with protease inhibitor-sparing regimens: Evaluation of nevirapine and delavirdine." Clin Infect Dis 30 (2000): s130-4

4. Perry CM, Scott LJ "Delavirdine - A review of its use in HIV infection." Drugs 60 (2000): 1411-44

5. Barreto J, Warnke D, Temesgen Z "Antiretroviral drugs." J Clin Pharmacol 47 (2007): 1570-9

6. Davey RT Jr, Kovacs JA, Metcalf JA, Boyle J, Chaitt DG, Eastman PS, Freimuth WW, Falloon J, Herpin BR, Masur H, Polis MA, Reed GF, Walker RE "Randomized, controlled phase I/II, trial of combination therapy with delavirdine (U-90152S) and conventional nucleosides in huma immunodeficiency virus type 1-infected patients." Antimicrob Agents Chemother 40 (1996): 1657-64

7. Coleman RL, Holtzer CD "Use of nonnucleoside reverse-transcriptase inhibitors." Am J Health Syst Pharm 55 (1998): 283-7

8. Moyle G "The emerging roles of non-nucleoside reverse transcriptase inhibitors in antiretroviral therapy." Drugs 61 (2001): 19-26

Further information

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.