Rescriptor Side Effects
Please note - some side effects for Rescriptor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Rescriptor - for the Consumer
Rescriptor
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rescriptor:
Seek medical attention right away if any of these SEVERE side effects occur when using Rescriptor:Bronchitis; depression; diarrhea; headache; nausea; redistribution of body fat; sleeplessness; stomach pain.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters; eye infection; fever; inflammation of the eye; mouth sores; muscle or joint pain; rash; swelling.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopRescriptor Side Effects - for the Professional
Rescriptor
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.
| 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.
| Study 21 Part II | Study 13C | ||||
|
ZDV + 3TC (n = 123) |
400 mg t.i.d. Rescriptor + ZDV (n = 123) |
400 mg t.i.d. Rescriptor + ZDV + 3TC (n = 119) |
ZDV + ddI, ddC, or 3TC (n = 172) |
400 mg t.i.d. Rescriptor + ZDV + ddI, ddC, or 3TC (n = 170) |
|
| Adverse Events |
% 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) | 1.7 (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.
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.
| Adverse Events/Toxicity Limits | Study 21 Part II | Study 13C | |||
|
ZDV + 3TC (n = 123) |
400 mg t.i.d. Rescriptor + ZDV (n = 123) |
400 mg t.i.d. Rescriptor + ZDV + 3TC (n = 119) |
ZDV + ddI, ddC, or 3TC (n = 172) |
400 mg t.i.d. Rescriptor + ZDV + ddI, ddC, or 3TC (n = 170) |
|
| % pts. | % pts. | % pts. | % pts. | % 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 × ULN |
0 | 0 | 1.7 | 2.9 | 2.4 |
|
Activated partial thromboplastin (APTT) >2.33 × ULN |
0 | 0.8 | 0 | 5.8 | 2.4 |
| Chemistry | |||||
|
Alananine aminotransferase (ALT/SGPT) >5 × ULN |
2.5 | 4.1 | 5.1 | 3.5 | 4.1 |
|
Amylase >2 × ULN |
0.8 | 2.5 | 2.6 | 3.5 | 2.9 |
|
Aspartate aminotransferase (AST/SGOT) >5 × ULN |
1.6 | 2.5 | 3.4 | 3.5 | 2.3 |
|
Bilirubin >2.5 × ULN |
0.8 | 2.5 | 1.7 | 1.2 | 0 |
|
Gamma glutamyl transferase (GGT) >5 × 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 | 0.0 |
N/A = not applicable because no predose values were obtained for patients.
TopSide Effects by Body System - for Healthcare Professionals
General
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.
Dermatologic
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, further more, 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
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
Other side effects have included headache (11.2% to 16.8%), 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
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
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
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
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.
Psychiatric
Psychiatric side effects have included depressive symptoms (4.9% to 12.6%), anxiety (2.4% to 6.7%), paranoid symptoms, nervousness, manic symptoms, and emotional lability during clinical trials of delavirdine with other antiretroviral agents.
Nervous system
Nervous system side effects have included insomnia (1.2% to 5%), abnormal coordination, agitation, amnesia, change in dreams, cognitive impairment, confusion, decreased libido, disorientation, dizziness, euphoria, hallucination, 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
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
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
Ocular side effects have included blepharitis, blurred vision, conjunctivitis, diplopia, dry eyes, and photophobia during clinical trials of delavirdine with other antiretroviral agents.
Musculoskeletal
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
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.
Hypersensitivity
Hypersensitivity side effects have included allergic reaction during clinical trials of delavirdine with other antiretroviral agents.
Other
Redistribution and 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.
TopMore Rescriptor resources
- Rescriptor Prescribing Information (FDA)
- Rescriptor Concise Consumer Information (Cerner Multum)
- Rescriptor Monograph (AHFS DI)
- Rescriptor Advanced Consumer (Micromedex) - Includes Dosage Information
- Rescriptor MedFacts Consumer Leaflet (Wolters Kluwer)
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