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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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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.
TopSevere 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.
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 (ie, ACTG grade 1 or 2) intensity. The most frequently reported drug-related adverse event (ie, 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 Grade† | Rescriptor 400 mg TID (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 epideral 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%) | |
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 | ||||
|---|---|---|---|---|---|
| Adverse Events | ZDV + 3TC (N = 123) |
400 mg tid Rescriptor + ZDV (N = 123) |
400 mg tid Rescriptor + ZDV + 3TC (N = 119) |
ZDV + ddI, ddC, or 3TC (N = 172) |
400 mg tid Rescriptor + ZDV + ddI, ddC or 3TC (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) | 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) |
Other adverse events that occurred in patients receiving Rescriptor (in combination treatment) in all phase II and III studies, and 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.
| Study 21 Part II | Study 13C | |||||
|---|---|---|---|---|---|---|
| Adverse Events | Toxicity Limit | ZDV + 3TC N = 123 |
400 mg tid Rescriptor + ZDV N = 123 |
400 mg tid Rescriptor + ZDV + 3TC N = 119 |
ZDV + ddI, ddC or 3TC N = 172 |
400 mg tid Rescriptor + ZDV + ddI, ddC or 3TC N = 170 |
| % pts. | % pts. | % pts. | % pts. | % pts. | ||
| N/A = not applicable because no predose values were obtained for patients | ||||||
| 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 |
More resources:
Rescriptor - Includes detailed dosage instructions.
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