Applies to nelfinavir: oral tablet.
Serious side effects of Nelfinavir
Along with its needed effects, nelfinavir 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 nelfinavir:
Less common
- Anxiety
- bleeding gums
- bloating
- blood in the urine or stools
- bloody, black, tarry stools
- blurred vision
- chest pain
- chills
- coma
- confusion
- constipation
- cool, pale skin
- cough
- darkened urine
- dehydration
- dizziness
- dry mouth
- fast heartbeat
- fever
- flushed, dry skin
- fruity mouth odor
- increased hunger
- increased thirst
- increased urination
- indigestion
- joint pain, stiffness, or swelling
- loss of appetite
- nausea
- nervousness
- nightmares
- painful or difficult urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pinpoint red spots on the skin
- seizures
- shakiness
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sweating
- swelling of the feet or lower legs
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
- weight loss
Incidence not known
- Clay-colored stools
- difficulty with breathing
- drowsiness
- fainting
- headache
- irregular heartbeat
- muscle tremors
- noisy breathing
- rapid, deep breathing
- recurrent fainting
- restlessness
- skin rash
- unpleasant breath odor
- vomiting of blood
Other side effects of Nelfinavir
Some side effects of nelfinavir 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:
More common
- Diarrhea
Less common
- Acid or sour stomach
- belching
- burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
- difficulty in moving
- discouragement
- feeling sad or empty
- heartburn
- increase in body movements
- irritability
- loss of interest or pleasure
- muscle aches, cramps, pain, or stiffness
- muscular tenderness, wasting or weakness
- passing gas
- redistribution or accumulation of body fat
- sleepiness or unusual drowsiness
- trouble concentrating
- trouble sleeping
For Healthcare Professionals
Applies to nelfinavir: oral powder for reconstitution, oral tablet.
General
Most side effects were of mild severity. The most common side effect was diarrhea, which was usually of mild to moderate severity.[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (up to 20%)
Common (1% to 10%): Nausea, flatulence
Frequency not reported: Abdominal pain, dyspepsia, epigastric pain, gastrointestinal bleeding, increased amylase, mouth ulceration, pancreatitis, vomiting[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]
Common (1% to 10%): Decreased lymphocytes, decreased neutrophils, decreased hemoglobin
Frequency not reported: Anemia, leukopenia, thrombocytopenia
HIV protease inhibitor therapy:
-Frequency not reported: Increased bleeding (including spontaneous skin hematomas, hemarthrosis) in hemophiliacs[Ref]
Hepatic
Common (1% to 10%): Elevated AST, elevated ALT
Frequency not reported: Elevated GGT, abnormal liver function tests, hepatitis
Postmarketing reports: Jaundice, bilirubinemia[Ref]
Musculoskeletal
Common (1% to 10%): Elevated creatine kinase
Frequency not reported: Arthralgia, arthritis, back pain, cramps, increased creatine phosphokinase, myalgia, myasthenia, myopathy[Ref]
Dermatologic
Common (1% to 10%): Rash
Frequency not reported: Dermatitis, folliculitis, fungal dermatitis, maculopapular rash, pruritus, sweating, urticaria[Ref]
Nervous system
Frequency not reported: Dizziness, headache, hyperkinesia, migraine, paresthesia, seizures, somnolence[Ref]
Other
Frequency not reported: Accidental injury, asthenia, fever, malaise, pain[Ref]
Respiratory
Frequency not reported: Dyspnea, pharyngitis, rhinitis, sinusitis[Ref]
Cardiovascular
Postmarketing reports: QTc prolongation, torsades de pointes[Ref]
Metabolic
Frequency not reported: Anorexia, increased alkaline phosphatase, increased LDH, hyperlipidemia, hyperuricemia, hyperglycemia, hypoglycemia, dehydration, redistribution/accumulation of body fat
Postmarketing reports: Metabolic acidosis
Combination antiretroviral therapy:
-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")
HIV protease inhibitor therapy:
-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, ketoacidosis[Ref]
Psychiatric
Frequency not reported: Anxiety, depression, emotional lability, insomnia, sleep disorder, suicidal ideation[Ref]
Hypersensitivity
Frequency not reported: Allergic reaction
Postmarketing reports: Hypersensitivity reactions (including bronchospasm, moderate to severe rash, fever, edema)[Ref]
Renal
Frequency not reported: Kidney calculus[Ref]
Genitourinary
Frequency not reported: Sexual dysfunction, urine abnormality[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)
Ocular
Frequency not reported: Acute iritis, eye disorder[Ref]
