Note: This document contains side effect information about saquinavir. Some of the dosage forms listed on this page may not apply to the brand name Invirase.
Common side effects of Invirase include: abdominal distress, diarrhea, and nausea. Other side effects include: vomiting. See below for a comprehensive list of adverse effects.
Applies to saquinavir: oral capsule, oral tablet
Along with its needed effects, saquinavir (the active ingredient contained in Invirase) 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 immediately if any of the following side effects occur while taking saquinavir:
Some side effects of saquinavir 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:
Applies to saquinavir: oral capsule, oral tablet
Nausea, vomiting, diarrhea, fatigue, flatulence, and abdominal pain have been reported the most frequently with this drug (plus ritonavir). Additional side effects have been reported during postmarketing experience that were similar to those observed in clinical trials with saquinavir (the active ingredient contained in Invirase) mesylate and saquinavir soft gel capsules alone or in combination with ritonavir.
Very common (10% or more): Nausea, diarrhea
Common (1% to 10%): Vomiting, abdominal distension, abdominal pain, upper abdominal pain, constipation, dry mouth, dyspepsia, eructation, flatulence, lip dry, loose stools, increased blood amylase
Uncommon (0.1% to 1%): Pancreatitis
Frequency not reported: Abdominal discomfort, ascites, bucca mucosa ulceration, dysphagia, gastritis, gastrointestinal (GI) hemorrhage, intestinal obstruction, cheilitis, frequent bowel movements, discolored feces, bloodstained feces, gastralgia, GI inflammation, gingivitis, GI ulcer, glossitis, hemorrhoids, melena, painful defecation, parotid disorder, rectal hemorrhage, salivary gland disorder, stomatitis, tooth disorder, abdominal colic, esophageal ulceration, esophagitis, gastroesophageal reflux, infectious diarrhea, pruritus ani, pyrosis, stomach upset, toothache
Very common (10% or more): Increased blood cholesterol, increased blood triglycerides, increased low-density lipoprotein
Common (1% to 10%): Diabetes mellitus/hyperglycemia, anorexia, increased appetite
Uncommon (0.1% to 1%): Decreased appetite
Frequency not reported: Dehydration, hypertriglyceridemia, increased alkaline phosphatase, increased LDH, hypoglycemia, hyperlipidemia, appetite disturbance, increased blood glucose, decreased blood glucose, hypercalcemia, hypocalcemia, hyperphosphatemia, hypophosphatemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia
Postmarketing reports: Ketoacidosis, metabolic abnormalities (e.g., hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperlactatemia)
-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), increased blood lipid levels, increased glucose levels
Protease inhibitor therapy:
-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, diabetic ketoacidosis
Diabetes mellitus/hyperglycemia was sometimes associated with ketoacidosis during postmarketing experience.
Redistribution/accumulation of body fat has been reported with antiretroviral therapy; causality has not been established.
Very common (10% or more): Decreased platelet count
Common (1% to 10%): Anemia, decreased hemoglobin, decreased lymphocyte count, decreased WBC count
Uncommon (0.1% to 1%): Neutropenia
Frequency not reported: Hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia, splenomegaly, dermal bleeding, microhemorrhages
Protease inhibitor therapy:
-Frequency not reported: Increased bleeding (including spontaneous skin hematomas, hemarthrosis) in hemophiliacs
Increased bleeding (including spontaneous skin hematomas and hemarthrosis) in patients with hemophilia type A and B has been associated with protease inhibitors. In many of the reported cases, treatment with protease inhibitors was continued or restarted and some patients required additional factor VIII. A causal relationship between protease inhibitor therapy and these episodes has not been established.
Very common (10% or more): Elevated ALT, elevated AST
Common (1% to 10%): Increased blood bilirubin
Uncommon (0.1% to 1%): Hepatitis, jaundice
Frequency not reported: Chronic active hepatitis, hepatomegaly, hyperbilirubinemia, portal hypertension, elevated GGT, hepatosplenomegaly, severe cutaneous reaction associated with increased liver function tests, increased transaminase levels, exacerbation of chronic liver disease with grade 4 elevated liver function tests, worsening liver disease, severe hepatocellular toxicity (presenting as increased hepatic transaminases), sclerosing cholangitis, cholelithiasis, liver enzyme disorder
There have been reports of worsening liver disease in patients with underlying hepatitis B or C, cirrhosis, chronic alcoholism, and/or other underlying liver abnormalities.
Severe hepatocellular toxicity (which presented as increased hepatic transaminases) occurred in healthy subjects exposed to this drug (plus ritonavir) and rifampin. Transaminases increased up to more than 20-fold the upper limit of normal in some patients and were associated with GI symptoms (including abdominal pain, gastritis, nausea, vomiting). Clinical symptoms resolved and hepatic transaminases returned to normal after all 3 drugs were stopped.
Rare (less than 0.1%): Second or third degree atrioventricular block
Frequency not reported: QT interval prolongation, PR interval prolongation, heart murmur, hypertension, hypotension, thrombophlebitis, vasoconstriction/peripheral vasoconstriction, cyanosis, heart rate disorder, heart valve disorder, vein distension
Postmarketing reports: Torsades de pointes (rarely)
This drug (plus ritonavir) showed a dose-dependent prolongation of the QT and PR intervals.
Common (1% to 10%): Fatigue, fever/pyrexia, asthenia/weakness, increased fat tissue, malaise
Uncommon (0.1% to 1%): Mucosal ulceration
Frequency not reported: Chest pain, edema, wasting syndrome, intoxication, increased weight, mucosal damage, retrosternal pain, shivering, generalized weakness, earache, ear pressure, otitis, abscess, bacterial infection, candidiasis, herpes simplex, herpes zoster, mycotic infection, staphylococcal infections, decreased weight, external parasites, cellulitis, molluscum contagiosum, moniliasis
-Frequency not reported: Increased weight
Common (1% to 10%): Pneumonia, bronchitis, influenza, sinusitis, dyspnea
Frequency not reported: Cough, epistaxis, hemoptysis, laryngitis, pharyngitis, respiratory disorder, rhinitis, upper respiratory tract infection, angina tonsillaris, pulmonary disease
Common (1% to 10%): Acquired lipodystrophy, rash, pruritus, dry skin, eczema, alopecia, lipoatrophy
Uncommon (0.1% to 1%): Stevens-Johnson syndrome, bullous dermatitis
Frequency not reported: Acne, drug eruption, erythema, severe cutaneous reaction associated with increased liver function tests, increased sweating, urticaria, dermatitis, bullous dermatitis skin eruption (including with polyarthritis), folliculitis, furunculosis, hair changes, hot flushes, maculopapular rash, photosensitivity reaction, seborrheic dermatitis, skin disorder, skin nodule, skin pigment changes, skin ulceration, verruca, xeroderma, exanthema, nail disorders, night sweats, psoriasis
Postmarketing reports: Lipodystrophy (including loss of peripheral and facial subcutaneous fat, increased intraabdominal and visceral fat, breast hypertrophy, dorsocervical fat accumulation [buffalo hump])
Common (1% to 10%): Headache, paresthesia, peripheral neuropathy, dizziness, dysgeusia/taste alteration
Uncommon (0.1% to 1%): Somnolence, convulsions
Frequency not reported: Abnormal coordination, hypoesthesia, intracranial hemorrhage (sometimes leading to death), tremor, loss of consciousness, syncope, tinnitus, dysarthria, dysesthesia, ataxia, extremity numbness, face numbness, facial pain, hyperesthesia, hyperreflexia, hyporeflexia, lethargy, lightheadedness, paresis, poliomyelitis, progressive multifocal leukoencephalopathy, seizures, spasms, decreased hearing, stroke, myelopolyradiculoneuritis, prickly sensation
Common (1% to 10%): Decreased libido, sleep disorder
Frequency not reported: Anxiety/anxiety attack, confusion/confusional state, depression, insomnia, libido disorder, psychotic disorder/psychosis, suicide attempt, agitation, amnesia, euphoria, excessive dreaming, hallucination, irritability, overdose effect, psychic disorders, reduced intellectual ability, speech disorder
Common (1% to 10%): Back pain, muscle spasms
Frequency not reported: Arthralgia, myalgia, polyarthritis, elevated blood creatine phosphokinase, arthritis, muscle cramps, musculoskeletal pain, musculoskeletal disorders, stiffness, tissue changes, trauma, leg cramps
Combination antiretroviral therapy:
-Frequency not reported: Osteonecrosis
Protease inhibitor therapy:
-Rare (less than 0.1%): Rhabdomyolysis
-Frequency not reported: Increased creatine phosphokinase, myalgia, myositis
Common (1% to 10%): Hypersensitivity
Frequency not reported: Allergic reaction, drug fever
Common (1% to 10%): Increased blood creatinine
Uncommon (0.1% to 1%): Renal impairment
Frequency not reported: Nephrolithiasis, acute renal insufficiency
Uncommon (0.1% to 1%): Visual impairment
Frequency not reported: Blepharitis, dry eye syndrome, eye irritation, visual disturbance, xerophthalmia, chalazion, cytomegalovirus retinitis
Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)
Frequency not reported: Enlarged prostate, pelvic pain, vaginal discharge, micturition disorder, urinary tract infection, epididymitis, impotence, menstrual disorder, menstrual irregularity, nocturia, penis disorder, renal calculus, renal colic, urinary tract bleeding
Frequency not reported: Acute myeloid leukemia, papillomatosis, skin papilloma, tumor
Frequency not reported: Hyperprolactinemia, increased thyroid stimulating hormone
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Invirase