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Rescriptor Side Effects

Generic Name: delavirdine

Note: This document contains side effect information about delavirdine. Some of the dosage forms listed on this page may not apply to the brand name Rescriptor.

In Summary

Common side effects of Rescriptor 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

Along with its needed effects, delavirdine (the active ingredient contained in Rescriptor) 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 Less common
  • Skin rash with symptoms such as fever, blistering, oral lesions, conjunctivitis, swelling, muscle aches, or joint aches
Rare
  • 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

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
  • 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
  • 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

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

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]

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]

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

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]

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]

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

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

References

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

2. "Product Information. Rescriptor (delavirdine)." Pharmacia and Upjohn, Kalamazoo, MI.

3. 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

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

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

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

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

8. Davey RT Jr, Chaitt DG, Reed GF, Freimuth WW, Herpin BR, Metcalf JA, Eastman PS, Falloon J, Kovacs JA, Polis MA, Walker RE, Masur H, Boyle J "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

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.

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