Fortovase Side Effects

Generic name: saquinavir

Medically reviewed by Drugs.com. Last updated on Jan 11, 2025.

Note: This document provides detailed information about Fortovase Side Effects associated with saquinavir. Some dosage forms listed on this page may not apply specifically to the brand name Fortovase.

Applies to saquinavir: oral tablet.

Serious side effects of Fortovase

Along with its needed effects, saquinavir (the active ingredient contained in Fortovase) 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:

Other side effects of Fortovase

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:

Precautions

It is very important that your doctor check your and your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You should not take this medicine if you are also using alfuzosin (Uroxatral®), atazanavir (Reyataz®), cisapride (Propulsid®), clozapine (Clozaril®), dapsone, dasatinib (Sprycel®), haloperidol (Haldol®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), quinine, rifampin (Rifadin®), sertindole, sildenafil (Revatio®), sunitinib (Sutent®), tacrolimus (Prograf®), trazodone (Desyrel®, Oleptro®), triazolam (Halcion®), ziprasidone (Geodon®), ergotamine medicines (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®), medicine for heart rhythm problems (eg, amiodarone, bepridil, disopyramide, dofetilide, flecainide, lidocaine, propafenone, quinidine, Cordarone®, Tambocor®, Tikosyn®), medicine to lower cholesterol (eg, lovastatin, simvastatin, Advicor®, Altoprev®, Mevacor®, Simcor®, Vytorin®, Zocor®), medicine to treat an infection (eg, clarithromycin, erythromycin, halofantrine, pentamidine, Biaxin®, Nebupent®), or phenothiazine medicines (eg, chlorpromazine, thioridazine, Mellaril®, Thorazine®). Taking any of these together with this medicine may increase the chance for serious side effects.

Do not use this medicine together with rilpivirine (Edurant®). Do not switch rilpivirine to saquinavir/ritonavir without a washout period of at least 2 weeks.

This medicine may decrease the effects of some oral contraceptives (birth control pills). To keep from getting pregnant, use an additional form of birth control together with your pills, such as condoms, a diaphragm, contraceptive foam or jelly.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as PR or QT prolongation.

This medicine may increase blood sugar levels. Diabetic patients should check with their doctor if they notice a change in blood or urine sugar tests.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders, such as Graves' disease, polymyositis, and Guillain-Barré syndrome may also occur.

This medicine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area, or a loss of fat from the legs, arms, and face.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort, garlic capsules) or vitamin supplements.

For healthcare professionals

Applies to saquinavir: oral capsule, oral tablet.

General adverse events

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]

See also:

Further information

Fortovase side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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