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

Summary

Common side effects of Invirase include: abdominal distress, diarrhea, and nausea. Other side effects include: vomiting. Continue reading for a comprehensive list of adverse effects.

Applies to saquinavir: oral tablet.

Serious side effects of Invirase

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:

More common

• Chest pain
• chills
• cough
• fever
• increased amount of fat in the upper back and neck, or around the chest and stomach area
• loss of fat from the legs, arms, and face
• sneezing
• sore throat
• tightness in the chest
• trouble breathing

Less common

• Blurred vision
• cough-producing mucus
• diarrhea
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• general feeling of discomfort or illness
• headache
• increased hunger
• increased thirst
• increased urination
• joint pain
• loss of appetite
• loss of consciousness
• muscle aches and pains
• nausea
• runny nose
• shivering
• skin rash
• sore throat
• stomachache
• sweating
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness
• vomiting

Rare

• Burning or prickling sensation
• confusion
• dehydration
• dry or itchy skin

Other side effects of Invirase

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:

Less common

• Back pain
• belching
• bloated or full feeling
• change in taste
• decreased interest in sexual intercourse
• difficulty having a bowel movement
• discouragement
• excess air or gas in the stomach or bowels
• fear
• feeling sad or empty
• headache
• heartburn
• inability to have or keep an erection
• indigestion
• irritability
• lack of appetite
• loss in sexual ability, desire, drive, or performance
• loss of interest or pleasure
• mouth ulcers
• nervousness
• pain or tenderness around the eyes and cheekbones
• passing gas
• skin rash, encrusted, scaly, and oozing
• skin warts
• stomach upset, discomfort, or pain
• stuffy nose
• tiredness
• trouble concentrating
• weakness

For Healthcare Professionals

Applies to saquinavir: oral capsule, oral tablet.

General

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.^[Ref]

Gastrointestinal

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^[Ref]

Metabolic

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.^[Ref]

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)

Antiretroviral therapy:

-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^[Ref]

Hematologic

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.^[Ref]

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^[Ref]

Hepatic

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.^[Ref]

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^[Ref]

Cardiovascular

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)^[Ref]

This drug (plus ritonavir) showed a dose-dependent prolongation of the QT and PR intervals.^[Ref]

Other

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

Antiretroviral therapy:

-Frequency not reported: Increased weight^[Ref]

Respiratory

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^[Ref]

Dermatologic

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])^[Ref]

Nervous system

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^[Ref]

Psychiatric

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^[Ref]

Musculoskeletal

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^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Frequency not reported: Allergic reaction, drug fever^[Ref]

Renal

Common (1% to 10%): Increased blood creatinine

Uncommon (0.1% to 1%): Renal impairment

Frequency not reported: Nephrolithiasis, acute renal insufficiency^[Ref]

Ocular

Uncommon (0.1% to 1%): Visual impairment

Frequency not reported: Blepharitis, dry eye syndrome, eye irritation, visual disturbance, xerophthalmia, chalazion, cytomegalovirus retinitis^[Ref]

Immunologic

Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)^[Ref]

Genitourinary

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^[Ref]

Oncologic

Frequency not reported: Acute myeloid leukemia, papillomatosis, skin papilloma, tumor^[Ref]

Endocrine

Frequency not reported: Hyperprolactinemia, increased thyroid stimulating hormone^[Ref]