FloLipid Side Effects
Generic name: simvastatin
Medically reviewed by Drugs.com. Last updated on Dec 3, 2024.
Note: This document provides detailed information about FloLipid.
Applies to simvastatin: oral suspension, oral tablet Side Effects associated with simvastatin. Some dosage forms listed on this page may not apply specifically to the brand name FloLipid.
Applies to simvastatin: oral suspension, oral tablet.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not use simvastatin (the active ingredient contained in FloLipid) if you are also taking boceprevir (Victrelis®), cobicistat-containing products (Stribild®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), danazol (Danocrine®), gemfibrozil (Lopid®), nefazodone (Serzone®), telaprevir (Incivek®), certain antibiotics (eg, clarithromycin, daptomycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Nizoral®), or medicines to treat HIV/AIDS (eg, atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®). Using these medicines together with simvastatin may increase your risk of muscle injury and could result in kidney problems.
Chinese patients who are taking large amounts of niacin (greater than or equal to 1 gram or 1000 milligrams per day) together with this medicine may have an increased risk for muscle injury. Talk to your doctor if you are Chinese or have Chinese ancestry and take large amounts of niacin (Niacor®, Niaspan®). You may need a different dose of this medicine.
Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These may be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM). Myopathy is more common when high doses of simvastatin (eg, 80 milligrams) are used, but some people get myopathy with lower doses.
Call your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
Call your doctor right away if you get a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver damage.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have major surgery, a major injury, or you develop other serious health problems.
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 or vitamin supplements.
Serious side effects of FloLipid
Along with its needed effects, simvastatin 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 simvastatin:
More common side effects
- dizziness
- fainting
- fast or irregular heartbeat
Less common side effects
- bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chills
- cough
- dark-colored urine
- difficult, burning, or painful urination
- difficulty with breathing
- difficulty with moving
- dry mouth
- ear congestion
- fever
- flushed, dry skin
- frequent urge to urinate
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- joint pain
- loss of consciousness
- lower back or side pain
- muscle cramps, spasms, stiffness, pain, tenderness, wasting, or weakness
- nausea
- runny or stuffy nose
- sneezing
- sore throat
- stomachache
- sweating
- swelling
- swollen joints
- trouble breathing
- unexplained weight loss
- unusual tiredness or weakness
- vomiting
Incidence not known
- blistering, peeling, or loosening of the skin
- bloating
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest tightness
- constipation
- diarrhea
- difficulty with chewing, swallowing, or talking
- double vision
- drooping eyelids
- general tiredness and weakness
- indigestion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of appetite
- muscle pain or weakness
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- 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
- skin rash, hives, or itching
- sores, ulcers, or white spots in the mouth or on the lips
- unusual bleeding or bruising
- upper right abdominal or stomach pain
- weakness in the arms, hands, legs, or feet
- yellow eyes or skin
Other side effects of FloLipid
Some side effects of simvastatin 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 side effects
- acid or sour stomach
- belching
- burning feeling in the chest or stomach
- dizziness or lightheadedness
- excess air or gas in the stomach or intestines
- feeling of constant movement of self or surroundings
- full feeling
- heartburn
- lack or loss of strength
- pain or tenderness around the eyes and cheekbones
- passing gas
- sensation of spinning
- skin rash, encrusted, scaly, and oozing
- stomach discomfort, upset, or pain
- tenderness in the stomach area
- trouble sleeping
Incidence not known
- being forgetful
- depression
- discoloration of the skin
- hair loss or thinning of the hair
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
For healthcare professionals
Applies to simvastatin: oral suspension, oral tablet.
General adverse events
The more commonly reported adverse effects have included upper respiratory infection, headache, abdominal pain, constipation, and nausea.[Ref]
Musculoskeletal
- Common (1% to 10%): Myalgia
- Uncommon (0.1% to 1%): Myopathy
- Frequency not reported: Elevations in creatine kinase, myopathy, dermatomyositis, arthralgia, tendon rupture
- Postmarketing reports: Muscle cramps, myalgia, rhabdomyolysis[Ref]
This drug causes dose-related myopathy which, in rare cases maybe severe and sometimes take the form of rhabdomyolysis with or without renal failure secondary to myoglobinuria; rarely fatalities have occurred. The incidence of myopathy with the 80 mg dose has been reported as disproportionately higher than that observed at lower doses and the risk of myopathy with simvastatin 80 mg/day is greater compared with other statins with similar or greater LDL-C lowering efficacy.[Ref]
Hepatic
- Common (1% to 10%): Elevations in liver function tests
- Frequency not reported: Hepatitis (including chronic active hepatitis), cholestatic jaundice, fatty changes in the liver, cirrhosis, hepatic failure, fulminant hepatic necrosis
- Postmarketing reports: Hepatic failure, hepatitis, jaundice[Ref]
Persistent elevations in transaminases of up to 3 times the upper limit of normal (3xULN) have been reported in 1% of patients. With therapy discontinuation or interruption, transaminase levels generally returned to pretreatment levels. There have been rare postmarketing reports of hepatic failure.[Ref]
Gastrointestinal
- Common (1% to 10%): Constipation, nausea, flatulence, diarrhea, dyspepsia, abdominal pain, gastritis
- Frequency not reported: Anorexia
- Postmarketing reports: Pancreatitis, vomiting[Ref]
Hematologic
- Frequency not reported: Hemolytic anemia, thrombocytopenia, leucopenia, thrombotic thrombocytopenic purpura (TTP)
- Postmarketing reports: Anemia[Ref]
Nervous system
- Common (1% to 10%): Headache, vertigo
- Frequency not reported: Cognitive impairment, cranial nerve dysfunction, tremor, vertigo, memory loss, paraesthesias, peripheral neuropathy, peripheral nerve palsy
- Postmarketing reports: Dizziness, paresthesia, peripheral neuropathy, cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion)[Ref]
Renal
- Frequency not reported: Myoglobinuria, acute renal failure secondary to rhabdomyolysis[Ref]
Cardiovascular
- Common (1% to 10%): Angina, edema, atrial fibrillation[Ref]
Dermatologic
- Common (1% to 10%): Eczema
- Frequency not reported: Pruritic rash, erythema multiform including Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura
- Postmarketing reports: Pruritus, alopecia, a variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails)[Ref]
Hypersensitivity
- Frequency not reported: Anaphylaxis, angioedema, urticaria, fever, chills, flushing, malaise, dyspnea
- Postmarketing reports: Hypersensitivity syndrome which has included some of the follow features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme including Stevens-Johnson syndrome[Ref]
Immunologic
- Postmarketing reports: Immune-mediated necrotizing myopathy[Ref]
Ocular
- Frequency not reported: Progression of cataracts, ophthalmoplegia[Ref]
Psychiatric
- Common (1%to 10%): Insomnia
- Postmarketing reports: Depression[Ref]
Genitourinary
- Common (1% to 10%): Urinary tract infection
- Frequency not reported: Impotence, testicular pain, proteinuria
- Postmarketing reports: Erectile dysfunction[Ref]
Oncologic
- Frequency not reported: Tumor growth, liver, thyroid, lung adenomas, carcinomas[Ref]
Metabolic
- Common (1% to 10%): Diabetes mellitus
- Frequency not reported: HbA1c and fasting serum glucose levels elevations
Respiratory
- Common (1% to 10%): Respiratory tract infection, bronchitis, sinusitis
- Postmarketing reports: Interstitial lung disease
Other
- Frequency not reported: Asthenia
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Frequently asked questions
- When is the best time to take simvastatin?
- Can I drink grapefruit juice with simvastatin?
- What are the side effects of statins?
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Further information
FloLipid 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.