Saquinavir Side Effects

Brand Names: Invirase, Fortovase

Please note - some side effects for Saquinavir 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).

Side Effects of Saquinavir - for the Consumer

Saquinavir Mesylate

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 Saquinavir Mesylate:

Anxiety; blurred vision; body fat changes; changes in sexual desire; constipation; diarrhea; dizziness; dry lips or skin; gas; headache; heartburn; loss of appetite; mouth sores; nausea; night sweats; sleeplessness; stomach discomfort; taste changes; tenderness or bleeding of the gums; tiredness; vomiting; warts; weight gain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; blood in the vomit or stools; chest tightness or pain; confusion; coughing up blood; dark urine; depression or thoughts of suicide; difficulty urinating; excessive thirst, hunger, or urination; fast heartbeat; fever; flu-like symptoms; itching; loss of coordination; numbness or tingling; pain in muscles or joints; reddened, blistered, or swollen skin; seizures; shortness of breath; stomach pain or tenderness; unusual bruising or bleeding; unusual vaginal discharge or odor; unusual weakness; white patches in mouth; yellowing of the skin or eyes.

Saquinavir

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 Saquinavir:

Anxiety; blurred vision; bronchitis; change in sexual ability; constipation; diarrhea; dry lips/skin; gas; headache; heartburn; loss of appetite; nausea; night sweats; sleeplessness; stomach discomfort; taste change; tiredness; vomiting; warts; weight gain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; bloody stools; body fat changes; chest pain; confusion; coughing up blood; dark urine; difficulty urinating; dizziness; excessive thirst, hunger, or urination; fast heartbeat; fever; flu-like symptoms; fruity breath odor; itching; loss of coordination; mental or mood changes; muscle pain; numbness or tingling; pneumonia; seizures; shortness of breath; slow onset of drowsiness; stomach pain or tenderness; tenderness or bleeding of gums; thoughts of hurting yourself; unusual vaginal discharge or odor; unusual weakness; white patches in mouth; yellowing of the skin or eyes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Side Effects by Body System

General

Gastrointestinal side effects have been reported the most frequently with the saquinavir soft gel capsule (SGC) formulation. The saquinavir hard gelatin capsule (HGC) formulation may have better gastrointestinal tolerance. The most common adverse effects associated with saquinavir in combination with other antiretroviral agents have included diarrhea, nausea, abdominal discomfort, and dyspepsia.

Gastrointestinal

Gastrointestinal (GI) side effects have included diarrhea (19.9%), nausea (10.6%), abdominal discomfort (8.6%), dyspepsia (8.4%), flatulence (5.7%), vomiting (2.9%), and abdominal pain (2.3%) during a noncomparative tolerability trial with saquinavir SGC and 2 or more other antiretroviral agents. Other GI side effects have included anorexia, decreased appetite, buccal mucosal ulceration, cheilitis, colic, constipation, dysphagia, esophageal ulceration, esophagitis, eructation, discolored and bloodstained feces, gastralgia, gastroesophageal reflux, gastritis, GI inflammation, gingivitis, GI ulcer, glossitis, hemorrhoids, infectious diarrhea, intestinal obstruction, melena, painful defecation, pancreatitis (including fatalities), parotid disorder, pruritus ani, pyrosis, rectal hemorrhage, salivary gland disorder, stomach upset, stomatitis, taste disturbances, toothache, and tooth disorder.

Cardiovascular

Cardiovascular side effects have rarely included chest pain, cyanosis, edema, heart murmur, heart rate disorder, heart valve disorder, hypertension, hypotension, fatal intracranial hemorrhage, peripheral vasoconstriction, stroke, syncope, thrombophlebitis, and vein distension.

Dermatologic

Dermatologic side effects have included skin rash and pruritus in 2% to 3% of patients. Less common side effects have included acne, alopecia, dermatitis, dry skin and lips, eczema, erythema, exanthema, folliculitis, furunculosis, hair changes, hot flushes, increased sweating, maculopapular rash, nail disorders, night sweats, papillomatosis, photosensitivity reaction, psoriasis, seborrheic dermatitis, skin disorder, skin nodule, skin pigment changes, skin ulceration, urticaria, verruca, and xeroderma.

Endocrine

Endocrine side effects have included increased TSH and, rarely, hyperprolactinemia.

Genitourinary

Genitourinary side effects have included enlarged prostate, epididymitis, impotence, menstrual disorder, menstrual irregularity, micturition disorder, nocturia, pelvic pain, penis disorder, renal calculus, renal colic, urinary tract bleeding, urinary tract infection, and vaginal discharge.

Hematologic

Hematologic side effects have included anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, dermal bleeding, microhemorrhages, and thrombocytopenia leading to death. Spontaneous bleeding in patients with hemophilia 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.

Hepatic

Hepatic side effects have included ascites, sclerosing cholangitis, cholelithiasis, hepatitis, hepatomegaly, hepatosplenomegaly, jaundice, liver enzyme disorder, and elevated ALT, AST, amylase, alkaline phosphatase, gamma glutamyl transpeptidase, and LDH. Severe cutaneous reactions associated with elevated liver function tests, isolated increase in transaminase, and exacerbation of chronic liver disease with Grade 4 elevated liver function tests have been reported. Although a causal relationship has not been established, there have been reports of exacerbation of chronic liver dysfunction, including portal hypertension, in patients with underlying hepatitis B or C, cirrhosis, or other underlying liver abnormalities.

Hypersensitivity

Hypersensitivity side effects have included drug fever, Stevens-Johnson syndrome, and bullous skin eruption and polyarthritis.

Immunologic

Immunologic side effects related to the resistance mechanism have included abscess, angina tonsillaris, bacterial infection, candidiasis, cellulitis, cytomegalovirus retinitis, herpes simplex, herpes zoster, influenza, lymphadenopathy, molluscum contagiosum, moniliasis, mycotic infection, staphylococcal infections, and tumor.

Metabolic

Metabolic side effects have included dehydration, appetite disturbance, hypertriglyceridemia, hyperglycemia, diabetes, hypoglycemia, hypercalcemia, hypocalcemia, hyperphosphatemia, hypophosphatemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia, hyperbilirubinemia, hyperlipidemia, weight decrease, and weight increase.

During postmarketing surveillance, the average time to onset of hyperglycemia and diabetes was 76 days; however, some events occurred as early as 4 days after the initiation of therapy.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, back pain, elevated creatine phosphokinase, leg cramps, muscle cramps, musculoskeletal pain, musculoskeletal disorders, myalgia, stiffness, tissue changes, and trauma.

Nervous system

Nervous system side effects have included headache (5%), and less commonly, ataxia, confusion, convulsions, dizziness, dysarthria, dysesthesia, extremity numbness, face numbness, facial pain, frequent bowel movements, hyperesthesia, hyperreflexia, hyporeflexia, insomnia, lightheadedness, dry mouth, myelopolyradiculoneuritis, paresis, paresthesia, peripheral neuropathy, poliomyelitis, prickly sensation, progressive multifocal leukoencephalopathy, seizures, somnolence, spasms, tremors, unconsciousness, weakness, decreased hearing, and tinnitus.

Ocular

Ocular side effects have included blepharitis, dry eye syndrome, eye irritation, visual disturbance, and xerophthalmia.

Oncologic

Oncologic side effects have rarely included acute myeloblastic leukemia.

Psychiatric

Psychiatric side effects have included agitation, amnesia, anxiety, anxiety attack, depression, euphoria, excessive dreaming, hallucination, irritability, lethargy, libido disorder, psychic disorders, psychosis, reduced intellectual ability, somnolence, speech disorder, and suicide attempt.

Renal

Renal side effects have included nephrolithiasis and acute renal insufficiency.

Respiratory

Respiratory side effects have included bronchitis, cough, dyspnea, epistaxis, hemoptysis, laryngitis, pharyngitis, pneumonia, pulmonary disease, respiratory disorder, rhinitis, sinusitis, and upper respiratory tract infection.

Other

Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving protease inhibitors. The mechanism and long-term consequences of these events are currently unknown and a causal relationship has not been established.

Other

Other side effects have included fatigue, fever, intoxication, asthenia, mucosa damage, external parasites, retrosternal pain, shivering, wasting syndrome, generalized weakness, earache, and otitis.

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