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Fortovase Side Effects

Generic Name: saquinavir

Note: This page contains information about the side effects of saquinavir. Some of the dosage forms included on this document may not apply to the brand name Fortovase.

For the Consumer

Applies to saquinavir: oral capsule, oral capsule liquid filled, oral tablet

In addition to its needed effects, some unwanted effects may be caused by saquinavir (the active ingredient contained in Fortovase). In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when taking saquinavir:

More common:
  • Chest pain
  • cough
  • fever or chills
  • 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
  • troubled 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

Severity: Minor

Some of the side effects that can occur with saquinavir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:
  • Acid or sour stomach
  • back pain
  • belching
  • bloated or full feeling
  • change in taste
  • decreased interest in sexual intercourse
  • difficulty having a bowel movement (stool)
  • discouragement
  • excess air or gas in the stomach or intestines
  • 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 Fortovase) 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

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]

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]

Hematologic

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]

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]

Hepatic

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]

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]

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]

References

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11. AIDSinfo. NIH. National Institutes of Health "Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf." ([2016 Mar 1]):

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17. von Hentig N, Muller A, Rottmann C, et al. "Pharmacokinetics of saquinavir, atazanavir and ritonavir in a boosted double-protease inhibitor twice-daily regimen." Antimicrob Agents Chemother 51 (2007): 1431-9

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21. Zorrilla CD, Van Dyke R, Bardeguez A, et al. "Clinical response and tolerability to and safety of saquinavir with low-dose ritonavir in human immunodeficiency virus type 1-infected mothers and their infants." Antimicrob Agents Chemother 51 (2007): 2208-10

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24. Martinez E, Mocroft A, GarciaViejo MA, PerezCuevas JB, Blanco JL, Mallolas J, Bianchi L, Conget I, Blanch J, Phillips A, Gatell "Risk of lipodystrophy in HIV-1-infected patients treated with protease inhibitors: a prospective cohort study." Lancet 357 (2001): 592-8

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Not all side effects for Fortovase may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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