Note: This document contains side effect information about lovastatin. Some dosage forms listed on this page may not apply to the brand name Altoprev.

Applies to lovastatin: oral tablet, oral tablet extended release.

Serious side effects of Altoprev

Along with its needed effects, lovastatin (the active ingredient contained in Altoprev) 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 lovastatin:

Less common

• Bladder pain
• bloody or cloudy urine
• chest tightness
• cough
• dark urine
• difficult, burning, or painful urination
• difficulty with moving
• fever
• frequent urge to urinate
• headache
• joint pain or swelling
• lower back or side pain
• muscle ache, cramp, spasm, stiffness, pain, tenderness, or weakness
• pain or tenderness around the eyes and cheekbones
• stuffy or runny nose
• swollen joints
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• Bloating
• chills
• constipation
• diarrhea
• difficulty swallowing
• dizziness
• fast heartbeat
• general tiredness and weakness
• hives, itching, skin rash
• indigestion
• light-colored stools
• loss of appetite
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• upper right abdominal or stomach pain
• vomiting
• yellow eyes or skin

Other side effects of Altoprev

Some side effects of lovastatin 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:

Less common

• Belching
• bloated or full feeling
• blurred vision
• difficulty having a bowel movement
• dizziness
• excess air or gas in the stomach or bowels
• heartburn
• lack or loss of strength
• passing gas
• stomach discomfort, upset, or pain

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• changes to the hair or nails
• confusion
• decreased interest in sexual intercourse
• depression
• discoloration or dryness of the skin or mucous membrane
• false sense of well-being
• fear or nervousness
• feeling of constant movement of self or surroundings
• forgetfulness
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• loss of libido
• memory loss
• mood swings
• partial or slight paralysis of the face
• personality changes
• sensation of spinning
• swelling of the breasts or breast soreness in both females and males
• tremor
• trouble sleeping
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet
• white area over the eye

For Healthcare Professionals

Applies to lovastatin: oral tablet, oral tablet extended release.

Hepatic

Common (1% to 10%): Elevations in liver function tests

Frequency not reported: Hepatitis (including chronic active hepatitis), cholestatic jaundice, fatty change in the liver, cirrhosis, fulminant hepatic necrosis^[Ref]

Persistent elevations in liver function tests to three times normal values have been reported in up to 2% of patients on lovastatin in clinical trials. Overall, 1.5% of patients were withdrawn from study due to elevations in serum transaminases. While most patients remained asymptomatic with these elevations, cases of cholestatic jaundice and hepatitis have been reported.

Liver function tests should be closely monitored. Lovastatin should be discontinued in patients with persistent, significant elevations (three times the upper limit of normal) in liver function parameters.^[Ref]

Gastrointestinal

Gastrointestinal side effects are among the most common complaints in patients on lovastatin (the active ingredient contained in Altoprev) These effects tend to be mild and transient in nature and will often dissipate with continued therapy.^[Ref]

Common (1% to 10%): Flatulence, abdominal pain, diarrhea, constipation, nausea

Frequency not reported: Dyspepsia, heartburn, anorexia, vomiting

Postmarketing reports: Abdominal discomfort^[Ref]

Musculoskeletal

Frequency not reported: Elevations in creatine kinase, muscle cramps, myopathy, rhabdomyolysis, arthralgia, myalgia, tendon rupture, dermatomyositis^[Ref]

HMG-CoA reductase inhibitors (statins) have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria, and renal failure. These conditions appear to be dose related, usually occurring with doses greater than 30 mg per day. The incidence and severity of myopathy may be increased by concomitant administration of lovastatin with drugs that can cause myopathy when given alone, such as gemfibrozil and other fibrates, niacin, and potent inhibitors of CYP450 3A4 (i.e., cyclosporine, antifungal azoles, macrolide antibiotics, large amounts of grapefruit juice). Other variables associated with an increased risk of statin-induced myopathy include, advanced age, small body stature, female gender, renal and/or hepatic dysfunction, perioperative periods, hypothyroidism, diabetes mellitus, and alcoholism.

Milder forms of myotoxicity (i.e., myalgia) are commonly reported and occur in approximately 5% to 7% of patients taking a statin drug.

Patients should be instructed to report promptly symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and if markedly elevated, lovastatin should be discontinued. The value of routine monitoring of creatine kinase is not known. In some studies up to 11% of patients experienced elevations in creatine kinase while on lovastatin. In most cases these elevations were mild, transient, and not associated with clinical symptoms.

Itraconazole used concomitantly with lovastatin has led to one reported case of severe rhabdomyolysis in a 63-year-old woman. Caution should be exercised when HMG-CoA reductase inhibitors and azole antifungals are prescribed concurrently.

Exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50.^[Ref]

Hematologic

Frequency not reported: Hemolytic anemia, thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), leukopenia (These effects may be manifestations of a hypersensitivity reaction)^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Frequency not reported: Cranial nerve dysfunction, tremor, vertigo, memory loss, drowsiness, weight loss, decline in cognitive function, paresthesias, peripheral neuropathy, peripheral nerve palsy

Postmarketing reports: Asthenia, fatigue, malaise, hypoesthesia, insomnia^[Ref]

Renal

Frequency not reported: Acute renal failure secondary to rhabdomyolysis^[Ref]

Dermatologic

Frequency not reported: Rash, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura, alopecia (These effects may be manifestations of a hypersensitivity reaction)^[Ref]

Endocrine

Frequency not reported: Hypospermia, gynecomastia, thyroid dysfunction, acid maltase deficiency (the genetic disorder also referred to as Pompe's Disease), pancreatitis^[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatic, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever (including severe hyperthermia), chills, flushing, malaise, dyspnea, toxic epidermal necrolysis^[Ref]

Immunologic

Frequency not reported: Lupus-like syndrome with positive ANA and elevated ESR, polymyalgia rheumatica, vasculitis^[Ref]

Ocular

Frequency not reported: Progression of cataracts, ophthalmoplegia^[Ref]

Metabolic

Very rare (less than 0.01%): Hyperkalemia^[Ref]

Psychiatric

Frequency not reported: Decreased libido, anxiety, insomnia, depression, suicidal thoughts, delusions, paranoia, agitation, nightmares^[Ref]

Genitourinary

Frequency not reported: Erectile dysfunction, impotence, testicular pain^[Ref]

Halkin, et al report a case in which use of both lovastatin and pravastatin on different occasions in the same patient led to reversible impotence. The impotence resolved within 2 weeks after discontinuation of the HMG-CoA reductase inhibitor.^[Ref]

Oncologic

Frequency not reported: Tumor growth, hepatocellular carcinomas and adenomas. pulmonary adenomas (all in rodents)^[Ref]

Respiratory

Postmarketing reports: Interstitial lung disease