Fortovase Side Effects

Generic name: saquinavir

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 Fortovase.

Some side effects of Fortovase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to saquinavir: oral capsule, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking saquinavir (the active ingredient contained in Fortovase) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking saquinavir and call your doctor at once if you have a serious side effect such as:

• increased thirst or urination, excessive hunger, fruity breath odor;

• cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath;

• fever, chills, body aches, flu symptoms, mouth and throat ulcers;

• any type of infection, skin infection, or open sores;

• rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

• diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

• swelling in your neck or throat (enlarged thyroid);

• muscle weakness, tired feeling, trouble speaking or swallowing, joint or muscle pain, feeling short of breath;

• weakness or prickly feeling in your fingers or toes;

• problems with walking, breathing, speech, swallowing, or eye movement; or

• severe lower back pain, loss of bladder or bowel control.

Less serious side effects of saquinavir may include:

• mild nausea, vomiting, stomach pain;

• tired feeling; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to saquinavir: oral capsule, oral tablet

General

Gastrointestinal disorders (such as nausea, vomiting, and diarrhea) have been reported the most frequently. Additional side effects have been reported during postmarketing experience that are 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.

Gastrointestinal

Nausea, diarrhea, vomiting, abdominal pain, and constipation were reported during a trial with saquinavir (the active ingredient contained in Fortovase) soft gel capsules in combination with ritonavir.

Very common (10% or more): Nausea (10.8%)
Common (1% to 10%): Diarrhea (8.1%), vomiting (7.4%), abdominal pain (6.1%), constipation (2%)
Frequency not reported: Abdominal discomfort, anorexia, dyspepsia, dysphagia, eructation, flatulence, gastritis, gastrointestinal hemorrhage, intestinal obstruction, dry mouth, mucosal ulceration, pancreatitis, decreased appetite, cheilitis, abdominal colic, constipation, esophageal ulceration, esophagitis, frequent bowel movements, discolored and bloodstained feces, gastralgia, gastroesophageal reflux, gastrointestinal inflammation, gingivitis, gastrointestinal ulcer, glossitis, hemorrhoids, infectious diarrhea, melena, painful defecation, parotid disorder, right and left upper quadrant abdominal pain, pruritus ani, pyrosis, rectal hemorrhage, salivary gland disorder, stomach upset, stomatitis, taste alteration, toothache, tooth disorder

Other

Common (1% to 10%): Fatigue (6.1%), fever (3.4%)
Frequency not reported: Ascites, asthenia, chest pain, edema, lethargy, wasting syndrome, intoxication, mucosa damage, external parasites, retrosternal pain, shivering, generalized weakness, earache, ear pressure, otitis, abscess, bacterial infection, candidiasis, cellulitis, herpes simplex, herpes zoster, molluscum contagiosum, moniliasis, mycotic infection, staphylococcal infections

Fatigue and fever were reported during a trial with saquinavir soft gel capsules in combination with ritonavir.

Metabolic

Common (1% to 10%): Lipodystrophy (5.4%), diabetes mellitus/hyperglycemia (2.7%)
Frequency not reported: Dehydration, increased or decreased appetite, hypertriglyceridemia, increased weight, raised amylase, increased alkaline phosphatase, raised LDH, hypoglycemia, hypercalcemia, hypocalcemia, hyperphosphatemia, hypophosphatemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia, hyperlipidemia, weight decrease, elevated cholesterol and/or triglyceride levels, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, breast enlargement, and "cushingoid appearance")
Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, diabetic ketoacidosis

Lipodystrophy and diabetes mellitus/hyperglycemia were reported during a trial with saquinavir soft gel capsules in combination with ritonavir.

Elevated cholesterol and/or triglyceride levels have been reported with saquinavir in combination with ritonavir.

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.

The mechanism and long-term consequences of body fat redistribution/accumulation are currently unknown and a causal relationship has not been established.

Respiratory

Pneumonia, bronchitis, influenza, and sinusitis were reported during a trial with saquinavir (the active ingredient contained in Fortovase) soft gel capsules in combination with ritonavir.

Common (1% to 10%): Pneumonia (5.4%), bronchitis (2.7%), influenza (2.7%), sinusitis (2.7%)
Frequency not reported: Cough, dyspnea, epistaxis, hemoptysis, laryngitis, pharyngitis, pulmonary disease, respiratory disorder, rhinitis, upper respiratory tract infection, angina tonsillaris

Dermatologic

Rash, pruritus, dry lips/skin, and eczema were reported during a trial with saquinavir (the active ingredient contained in Fortovase) soft gel capsules in combination with ritonavir.

Common (1% to 10%): Rash (3.4%), pruritus (3.4%), dry lips/skin (2%), eczema (2%)
Frequency not reported: Acne, alopecia, bullous dermatitis, drug eruption, erythema, severe cutaneous reaction associated with increased liver function tests, Stevens-Johnson syndrome, increased sweating, urticaria, dermatitis, exanthema, folliculitis, furunculosis, hair changes, hot flushes, maculopapular rash, nail disorders, night sweats, photosensitivity reaction, psoriasis, seborrheic dermatitis, skin disorder, skin nodule, skin pigment changes, skin ulceration, verruca, xeroderma

Musculoskeletal

Back pain was reported during a trial with saquinavir (the active ingredient contained in Fortovase) soft gel capsules in combination with ritonavir.

Common (1% to 10%): Back pain (2%)
Frequency not reported: Arthralgia, muscle spasms, myalgia, polyarthritis, elevated blood creatine phosphokinase, arthritis, leg cramps, muscle cramps, musculoskeletal pain, musculoskeletal disorders, stiffness, tissue changes, trauma

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, peripheral vasoconstriction, cyanosis, heart rate disorder, heart valve disorder, stroke, vein distension
Postmarketing reports: Torsades de pointes (rarely)

Saquinavir plus ritonavir show a dose-dependent prolongation of the QT and PR intervals.

Hematologic

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.

Frequency not reported: Anemia, hemolytic anemia, leukopenia, lymphadenopathy, neutropenia, pancytopenia, thrombocytopenia, splenomegaly, dermal bleeding, microhemorrhages, spontaneous bleeding (in patients with hemophilia A and B)

Hepatic

Frequency not reported: Chronic active hepatitis, hepatitis, hepatomegaly, hyperbilirubinemia, jaundice, portal hypertension, elevated ALT, elevated AST, elevated gamma glutamyl transpeptidase, sclerosing cholangitis, cholelithiasis, hepatosplenomegaly, liver enzyme disorder, severe cutaneous reactions associated with elevated liver function tests, isolated increase in transaminase, exacerbation of chronic liver disease with Grade 4 elevated liver function tests, worsening liver disease

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.

Hypersensitivity

Frequency not reported: Allergic reaction, drug fever, Stevens-Johnson syndrome, bullous skin eruption with polyarthritis

Immunologic

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

Nervous system

Frequency not reported: Headache, confusion, convulsions, abnormal coordination, dizziness, dysgeusia, hypoesthesia, insomnia, intracranial hemorrhage leading to death, tremors, unconsciousness, paresthesia, peripheral neuropathy, somnolence, sleep disorder, syncope, tinnitus, dysarthria, dysesthesia, ataxia, extremity numbness, face numbness, facial pain, hyperesthesia, hyperreflexia, hyporeflexia, lightheadedness, myelopolyradiculoneuritis, paresis, poliomyelitis, prickly sensation, progressive multifocal leukoencephalopathy, seizures, spasms, weakness, decreased hearing

Psychiatric

Frequency not reported: Anxiety, depression, libido disorder, psychotic disorder, suicide attempt, agitation, amnesia, anxiety attack, euphoria, excessive dreaming, hallucination, irritability, lethargy, overdose effect, psychic disorders, psychosis, reduced intellectual ability, somnolence, speech disorder

Genitourinary

Frequency not reported: 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, vaginal discharge

Ocular

Frequency not reported: Visual impairment, chalazion, blepharitis, dry eye syndrome, eye irritation, visual disturbance, xerophthalmia, cytomegalovirus retinitis

Oncologic

Frequency not reported: Acute myeloid leukemia, papillomatosis, tumor

Renal

Frequency not reported: Nephrolithiasis, acute renal insufficiency

Endocrine

Rare (less than 0.1%): Hyperprolactinemia
Frequency not reported: Increased TSH

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