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Rescriptor

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Rescriptor

Rescriptor

Rescriptor Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rescriptor (delavirdine mesylate) is an antiviral medication used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. Common side effects include nausea, diarrhea, headache, tiredness, changes in body fat, or worsening of a previous medical condition (such as an old infection).

The recommended dosage for Rescriptor Tablets is 400 mg (four 100-mg or two 200-mg tablets) 3 times daily. Rescriptor should be used in combination with other antiretroviral therapy. Rescriptor may interact with sildenafil, St. John's wort, blood thinners, cholesterol medications, antibiotics, heart or blood pressure medications, heart rhythm medicines, medications to prevent organ transplant rejection, other HIV medicines, sedatives, seizure medications, steroids, or stomach medications. Tell your doctor all medications and supplements you use. During pregnancy Rescriptor should be used only if prescribed. HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. This drug may be part of that treatment; consult your doctor. It is unknown if this drug passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Rescriptor (delavirdine mesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Rescriptor in Detail - Patient Information: Side Effects

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 serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may include:

  • mild nausea, vomiting, stomach pain, or bloating;
  • diarrhea or constipation;
  • headache, mood changes;
  • blurred vision;
  • cough, stuffy nose;
  • muscle or joint pain;
  • sleep problems (insomnia), unusual dreams;
  • tired feeling, trouble concentrating; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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.

Read the entire detailed patient monograph for Rescriptor (Delavirdine Mesylate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Rescriptor Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, diarrhea, headache, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression), signs of liver problems (such as persistent nausea, vomiting, stomach/abdominal pain, severe tiredness, yellowing eyes/skin, dark urine).

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

Delavirdine can commonly cause a rash that is usually not serious. A rash may occur within 1 to 3 weeks after you start delavirdine treatment. It appears mainly on the upper body and arms, but may also appear on the neck and face. After consultation with the doctor, most people can continue taking delavirdine and treat the rash if it is not severe. Non-serious rashes usually last less than 2 weeks. However, a severe rash or a rash with signs of a severe reaction requires immediate medical attention. Signs of a severe reaction that usually appear within the first 3 days of a serious rash include: fever, blisters, mouth sores, eye redness/swelling, swelling in other areas of the body, or muscle/joint pain. Since you may not be able to tell a common rash apart from a rare rash that could be a sign of a severe reaction, always seek immediate medical attention if you develop any rash or any of these symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Rescriptor (Delavirdine Mesylate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rescriptor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The safety of RESCRIPTOR Tablets alone and in combination with other therapies has been studied in approximately 6,000 patients receiving RESCRIPTOR. The majority of adverse events were of mild or moderate (i.e., ACTG Grade 1 or 2) intensity. The most frequently reported drug-related adverse event (i.e., events considered by the investigator to be related to the blinded study medication or events with an unknown or missing causal relationship to the blinded medication) among patients receiving RESCRIPTOR was skin rash (see Table 8 and PRECAUTIONS: Skin Rash).

Table 8: Percent of Patients With Treatment-Emergent Rash in Pivotal Trials (Studies 21 Part II and 13C)a

Percent of Patients With: Description of Rash Gradeb RESCRIPTOR 400 mg t.i.d.
(n = 412)
Control Group Patients
(n = 295)
Grade 1 rash Erythema, pruritus 69 (16.7%) 35 (11.9%)
Grade 2 rash Diffuse maculopapular rash, dry desquamation 59 (14.3%) 17 (5.8%)
Grade 3 rash Vesiculation, moist desquamation, ulceration 18 (4.4%) 0 (0.0%)
Grade 4 rash Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, necrosis requiring surgery, exfoliative dermatitis 0 (0.0%) 0 (0.0%)
Rash of any grade   146 (35.4%) 52 (17.6%)
Treatment discontinuation as a result of rash   13 (3.2%) 1 (0.3%)
a Includes events reported regardless of causality.
b ACTG Toxicity Grading System; includes events reported as “rash,” “maculopapular rash,” and “urticaria.”

Adverse events of moderate to severe intensity reported by at least 5% of evaluable patients in any treatment group in the pivotal trials, which includes patients receiving RESCRIPTOR in combination with zidovudine and/or lamivudine in Study 21 Part II for up to 98 weeks and in combination with zidovudine and either lamivudine, didanosine, or zalcitabine in Study 13C for up to 72 weeks are summarized in Table 9.

Table 9: Treatment-Emergent Events Regardless of Causality, of Moderate-to-Severe or Life-Threatening Intensity Reported by at Least 5% of Evaluablea Patients in Any Treatment Group

Adverse Events Study 21 Part II Study 13C
Zidovudine + Lamivudine
(n = 123)
400 mg t.i.d. RESCRIPTOR + Zidovudine
(n = 123)
400 mg t.i.d. RESCRIPTOR + Zidovudine + Lamivudine
(n = 119)
Zidovudine + Didanosine, Zalcitabine, or Lamivudine
(n = 172)
400 mg t.i.d. RESCRIPTOR + Zidovudine + Didanosine, Zalcitabine, or Lamivudine
(n = 170)
% of pts. (n) % of pts. (n) % of pts. (n) % of pts. (n) % of pts. (n)
Body as a Whole
Abdominal pain, generalized 2.4 (3) 3.3 (4) 5.0 (6) 17 (3) 2.4 (4)
Asthenia/fatigue 16.3 (20) 15.4 (19) 16.0 (19) 8.1 (14) 5.3 (9)
Fever 2.4 (3) 1.6 (2) 3.4 (4) 6.4 (11) 7.1 (12)
Flu syndrome 4.9 (6) 7.3 (9) 5.0 (6) 5.2 (9) 2.4 (4)
Headache 14.6 (18) 12.2 (15) 16.8 (20) 12.8 (22) 11.2 (19)
Localized pain 4.9 (6) 5.7 (7) 5.0 (6) 2.9 (5) 1.8 (3)
Digestive
Diarrhea 8.1 (10) 2.4 (3) 4.2 (5) 8.1 (14) 5.9 (10)
Nausea 17.1 (21) 20.3 (25) 16.8 (20) 9.3 (16) 14.7 (25)
Vomiting 8.9 (11) 4.9 (6) 2.5 (3) 4.1 (7) 6.5 (11)
Nervous
Anxiety 1.6 (2) 2.4 (3) 6.7 (8) 4.1 (7) 3.5 (6)
Depressive symptoms 6.5 (8) 4.9 (6) 12.6 (15) 3.5 (6) 5.9 (10)
Insomnia 4.9 (6) 4.9 (6) 5.0 (6) 2.9 (5) 1.2 (2)
Respiratory
Bronchitis 4.1 (5) 6.5 (8) 6.7 (8) 3.5 (6) 3.5 (6)
Cough 9.8 (12) 4.1 (5) 5.0 (6) 5.2 (9) 3.5 (6)
Pharyngitis 6.5 (8) 1.6 (2) 5.0 (6) 4.1 (7) 3.5 (6)
Sinusitis 8.9 (11) 7.3 (9) 5.0 (6) 2.3 (4) 1.2 (2)
Upper respiratory infection 11.4 (14) 6.5 (8) 7.6 (9) 8.7 (15) 4.7 (8)
Skin
Rashes 3.3 (4) 19.5 (24) 13.4 (16) 7.6 (13) 18.8 (32)
aEvaluable patients in Study 21 Part II were those who received at least 1 dose of study medication and returned for at least 1 clinic study visit. Evaluable patients in Study 13C were those who received at least 1 dose of study medication.

Other Adverse Events in Phase II/III Studies: Other adverse events that occurred in patients receiving RESCRIPTOR (in combination treatment) in all Phase II and III studies, considered possibly related to treatment, and of at least ACTG Grade 2 in intensity are listed below by body system.

Body as a Whole: Abdominal cramps, abdominal distention, abdominal pain (localized), abscess, allergic reaction, chills, edema (generalized or localized), epidermal cyst, fever, infection, infection viral, lip edema, malaise, Mycobacterium tuberculosis infection, neck rigidity, sebaceous cyst, and redistribution/accumulation of body fat (see PRECAUTIONS: Fat Redistribution).

Cardiovascular System: Abnormal cardiac rate and rhythm, cardiac insufficiency, cardiomyopathy, hypertension, migraine, pallor, peripheral vascular disorder, and postural hypotension.

Digestive System: Anorexia, bloody stool, colitis, constipation, decreased appetite, diarrhea (Clostridium difficile), diverticulitis, dry mouth, dyspepsia, dysphagia, enteritis at all levels, eructation, fecal incontinence, flatulence, gagging, gastroenteritis, gastroesophageal reflux, gastrointestinal bleeding, gastrointestinal disorder, gingivitis, gum hemorrhage, hepatomegaly, increased appetite, increased saliva, increased thirst, jaundice, mouth or tongue inflammation or ulcers, nonspecific hepatitis, oral/enteric moniliasis, pancreatitis, rectal disorder, sialadenitis, tooth abscess, and toothache.

Hemic and Lymphatic System: Adenopathy, bruising, eosinophilia, granulocytosis, leukopenia, pancytopenia, purpura, spleen disorder, thrombocytopenia, and prolonged prothrombin time.

Metabolic and Nutritional Disorders: Alcohol intolerance, amylase increased, bilirubinemia, hyperglycemia, hyperkalemia, hypertriglyceridemia, hyperuricemia, hypocalcemia, hyponatremia, hypophosphatemia, increased AST (SGOT), increased gamma glutamyl transpeptidase, increased lipase, increased serum alkaline phosphatase, increased serum creatinine, and weight increase or decrease.

Musculoskeletal System: Arthralgia or arthritis of single and multiple joints, bone disorder, bone pain, myalgia, tendon disorder, tenosynovitis, tetany, and vertigo.

Nervous System: Abnormal coordination, agitation, amnesia, change in dreams, cognitive impairment, confusion, decreased libido, disorientation, dizziness, emotional lability, euphoria, hallucination, hyperesthesia, hyperreflexia, hypertonia, hypesthesia, impaired concentration, manic symptoms, muscle cramp, nervousness, neuropathy, nystagmus, paralysis, paranoid symptoms, restlessness, sleep cycle disorder, somnolence, tingling, tremor, vertigo, and weakness.

Respiratory System: Chest congestion, dyspnea, epistaxis, hiccups, laryngismus, pneumonia, and rhinitis.

Skin and Appendages: Angioedema, dermal leukocytoclastic vasculitis, dermatitis, desquamation, diaphoresis, discolored skin, dry skin, erythema, erythema multiforme, folliculitis, fungal dermatitis, hair loss, herpes zoster or simplex, nail disorder, petechiae, non-application site pruritus, seborrhea, skin hypertrophy, skin disorder, skin nodule, Stevens-Johnson syndrome, urticaria, vesiculobullous rash, and wart.

Special Senses: Blepharitis, blurred vision, conjunctivitis, diplopia, dry eyes, ear pain, parosmia, otitis media, photophobia, taste perversion, and tinnitus.

Urogenital System: Amenorrhea, breast enlargement, calculi of the kidney, chromaturia, epididymitis, hematuria, hemospermia, impaired urination, impotence, kidney pain, metrorrhagia, nocturia, polyuria, proteinuria, testicular pain, urinary tract infection, and vaginal moniliasis.

Postmarketing Experience

Adverse event terms reported from postmarketing surveillance that were not reported in the Phase II and III trials are presented below.

Digestive System: Hepatic failure.

Hemic and Lymphatic System: Hemolytic anemia.

Musculoskeletal System: Rhabdomyolysis.

Urogenital System: Acute kidney failure.

Laboratory Abnormalities

Marked laboratory abnormalities observed in at least 2% of patients during Studies 21 Part II and 13C are summarized in Table 10. Marked laboratory abnormalities are defined as any Grade 3 or 4 abnormality found in patients at any time during study.

Table 10:Marked Laboratory Abnormalities Reported by ≥ 2% of Patients

Adverse Events/Toxicity Limits Study 21 Part II Study 13C
Zidovudine + Lamivudine
(n =123) % pts.
400 mg t.i.d. RESCRIPTOR + Zidovudine
(n =123) % pts.
400 mg t.i.d. RESCRIPTOR + Zidovudine + Lamivudine
(n = 119) % pts.
Zidovudine + Didanosine, Zalcitabine, or Lamivudine
(n = 172) % pts.
400 mg t.i.d. RESCRIPTOR + Zidovudine + Didanosine, Zalcitabine, or Lamivudine
(n = 170) % pts.
Hematology
Hemoglobin < 7 mg/dL 4.1 2.5 0.9 1.7 2.9
Neutrophils < 750/mm³ 5.7 4.9 3.4 10.4 7.6
Prothrombin time (PT) > 1.5 x ULN 0 0 1.7 2.9 2.4
Activated partial thromboplastin (APTT) > 2.33 x ULN 0 0.8 0 5.8 2.4
Chemistry
Alananine aminotransferase (ALT/SGPT) > 5 x ULN 2.5 4.1 5.1 3.5 4.1
Amylase > 2 x ULN 0.8 2.5 2.6 3.5 2.9
Aspartate aminotransferase (AST/SGOT) > 5 x ULN 1.6 2.5 3.4 3.5 2.3
Bilirubin > 2.5 x ULN 0.8 2.5 1.7 1.2 0
Gamma glutamyl transferase (GGT) > 5 x ULN N/A N/A N/A 4.1 1.8
Glucose (hypo/hyperglycemia) < 40 mg/dL > 250 mg/dL 4.1 0.8 1.7 1.2 0
N/A = not applicable because no predose values were obtained for patients.

Read the entire FDA prescribing information for Rescriptor (Delavirdine Mesylate) »

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Rescriptor - User Reviews

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