Generic Name: amlodipine (am LOE di peen)
Brand Names: Norvasc
What is amlodipine?
Amlodipine is a calcium channel blocker that dilates (widens) blood vessels and improves blood flow.
Amlodipine is also used to treat
high blood pressure(hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.
Amlodipine is for use in adults and children who are at least 6 years old.
Important information
Before taking amlodipine, tell your doctor if you have congestive heart failure or liver disease.
Drinking alcohol can further lower your blood pressure and may increase certain side effects of amlodipine.
If you are being treated for high blood pressure, keep using amlodipine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
Amlodipine is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.
Tell your doctor about all other heart or blood pressure medications you are taking.
Your chest pain may become worse when you first start taking amlodipine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.
Before taking this medicine
You should not take amlodipine if you are allergic to it.
To make sure amlodipine is safe for you, tell your doctor if you have:
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Amlodipine can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.
Amlodipine is not approved for use by anyone younger than 6 years old.
How should I take amlodipine?
Take amlodipine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
You may take amlodipine with or without food. Take the medicine at the same time each day.
Your blood pressure will need to be checked often.
Your chest pain may become worse when you first start taking amlodipine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.
If you are being treated for high blood pressure, keep using amlodipine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.
Your hypertension or heart condition may be treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or stop taking any of your medications without your doctor's advice. This is especially important if you also take nitroglycerin.
Amlodipine is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.
Store at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include rapid heartbeats, redness or warmth in your arms or legs, or fainting.
What should I avoid while taking amlodipine?
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Amlodipine side effects
Get emergency medical help if you have signs of an allergic reaction to amlodipine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, when you first start taking amlodipine, your angina may get worse or you could have a heart attack. Seek emergency medical attention or call your doctor right away if you have symptoms such as:chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.
Call your doctor at once if you have:
pounding heartbeats or fluttering in your chest;
worsening chest pain;
swelling in your feet or ankles;
severe drowsiness; or
a light-headed feeling, like you might pass out.
Common amlodipine side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect amlodipine?
Tell your doctor about all your current medicines and any you start or stop using, especially:
nitroglycerin;
simvastatin (Zocor, Simcor, Vytorin); or
any other heart or blood pressure medications.
This list is not complete. Other drugs may interact with amlodipine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use amlodipine only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Amlodipine Side Effects
In Summary
Commonly reported side effects of amlodipine include: edema. Other side effects include: fatigue, palpitations, and flushing. See below for a comprehensive list of adverse effects.
For the Consumer
Along with its needed effects, amlodipine 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 amlodipine:
More Common
- Swelling of the ankles or feet
Less Common
- Difficult or labored breathing
- dizziness
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- redness of the face, neck, arms, and occasionally, upper chest
- shortness of breath
- tightness in the chest
- wheezing
Rare
- Black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- chills
- cold and clammy skin
- cold sweats
- confusion
- dark yellow urine
- cough
- diarrhea
- dilated neck veins
- dizziness or lightheadedness when getting up from a lying or sitting position
- extra heartbeats
- extreme fatigue
- fainting
- fever
- itching of the skin
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- numbness and tingling of the face, fingers, or toes
- pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
- painful or difficult urination
- pale, bluish-colored, or cold hands or feet
- pinpoint red or purple spots on the skin
- red, irritated eyes
- redness of the face, neck, arms, and occasionally, upper chest
- redness, soreness or itching skin
- shakiness in the legs, arms, hands, or feet
- slow or irregular heartbeat
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sores, welting, or blisters
- sudden sweating
- sweating
- swelling of the face, fingers, feet, or lower legs
- swollen glands
- trembling or shaking of the hands or feet
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- weak or absent pulses in the legs
- weakness in the arms, hands, legs, or feet
- weight gain
- yellow eyes or skin
Incidence Not Known
- Abdominal or stomach pain
- clay-colored stools
- diarrhea
- headache
- loss of appetite
- nausea
- rash
- unpleasant breath odor
- vomiting of blood
- yellow eyes or skin
Some side effects of amlodipine 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
- Acid or sour stomach
- belching
- heartburn
- indigestion
- lack or loss of strength
- muscle cramps
- sleepiness or unusual drowsiness
- stomach discomfort, upset, or pain
Rare
- Abnormal dreams
- anxiety
- back pain
- bad unusual or unpleasant (after) taste
- bleeding gums
- blistering, crusting, irritation, itching, or reddening of the skin
- bloating
- bloody nose
- burning feeling in the chest or stomach
- burning while urinating
- burning, dry, or itching eyes
- change in color of the treated skin
- change in sense of smell
- change in taste
- changes in vision
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- cracked, dry, or scaly skin
- decreased sexual performance or desire
- depression
- difficulty with moving
- difficulty with swallowing
- discharge, excessive tearing
- double vision
- dry mouth
- dryness of the skin
- excess air or gas in the stomach or intestines
- excessive muscle tone
- eye pain
- feeling of constant movement of self or surroundings
- feeling of unreality
- feeling unusually cold
- flushed, dry skin
- fruit-like breath odor
- full feeling
- general feeling of discomfort or illness
- hair loss or thinning of the hair
- headache, severe and throbbing
- hearing loss
- hyperventilation
- increased appetite
- increased hunger
- increased sweating
- increased thirst
- increased urge to urinate during the night
- increased urination
- irritability
- irritation in the mouth
- lack of feeling or emotion
- loose stools
- loss of memory
- muscle pains or stiffness
- muscle tension or tightness
- muscle weakness
- nervousness
- pain
- pains in the stomach, side, or abdomen, possibly radiating to the back
- passing gas
- problems with memory
- redness and swelling of the gums
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- restlessness
- runny nose
- seeing double
- sensation of spinning
- sense of detachment from self or body
- shakiness and unsteady walk
- shivering
- sleeplessness
- sneezing
- stuffy nose
- sweating
- swollen joints
- tenderness in the stomach area
- thirst
- trouble in holding or releasing urine
- trouble sleeping
- twitching
- unable to sleep
- uncaring
- unexplained weight loss
- unsteadiness, trembling, or other problems with muscle control or coordination
- waking to urinate at night
- weight loss
Incidence Not Known
- Swelling of the breasts or breast soreness in both females and males
For Healthcare Professionals
Applies to amlodipine: oral tablet, oral tablet disintegrating
General
The most commonly reported side effects include headache,
edema, rash, fatigue, and dizziness.
[Ref]
Cardiovascular
Edema occurred in 14.6% of female patients given this drug compared to 5.6% of male patients, and was more likely to occur in patients given the 10 mg dose (compared to the 5 and 2.5 mg doses).
[Ref]
Very common (10% or more): Edema (up to 14.6%)
Very rare (less than 0.01%): Myocardial infarction, arrhythmia (including bradycardia, ventricular
tachycardia, atrial fibrillation),
vasculitis, cardiac failure, pulse irregularity, extrasystoles, hot flush
Frequency not reported: Tachycardia, peripheral ischemia, postural hypotension
[Ref]
Nervous system
Common (1% to 10%): Somnolence, dizziness, headache
Uncommon (0.1% to 1%): Tremor, taste perversion/dysgeusia,
syncope, hypoesthesia, paresthesia
Frequency not reported: Extrapyramidal syndrome, postural dizziness,
vertigo[Ref]
Headache occurred commonly during clinical trials, especially at the beginning of treatment.
Extrapyramidal syndrome may be associated with this drug.
[Ref]
Gastrointestinal
Uncommon (0.1% to 1%): Vomiting,
dyspepsia, altered bowel habits (including diarrhea and constipation), dry mouth
Dermatologic
Common (1% to 10%): Flushing
Other
Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%):
Tinnitus, asthenia, pain, malaise
Frequency not reported: Rigors, thirst
[Ref]
Genitourinary
Very rare (less than 0.01%):
Dysuria, polyuria
Musculoskeletal
Uncommon (0.1% to 1%): Arthralgia, myalgia, muscle cramps, back pain
Very rare (less than 0.01%): Muscle weakness
Frequency not reported: Arthrosis, twitching
[Ref]
Psychiatric
Uncommon (0.1% to 1%):
Insomnia, mood changes (including anxiety), depression
Rare (0.01% to 0.1%): Confusion
Frequency not reported: Abnormal dreams, depersonalization, nervousness, apathy, agitation
[Ref]
Respiratory
Uncommon (0.1% to 1%):
Dyspnea, rhinitis
Very rare (less than 0.01%): Cough
Frequency not reported: Epistaxis
[Ref]
Ocular
Uncommon (0.1% to 1%): Visual disturbance (including diplopia)
Very rare (less than 0.01%): Abnormal visual accommodation, xerophthalmia
Metabolic
Uncommon (0.1% to 1%): Weight increase/decrease
Very rare (less than 0.01%): Hyperglycemia, increased appetite
Frequency not reported: Anorexia
[Ref]
Hematologic
Uncommon (0.1% to 1%): Purpura
Endocrine
Uncommon (0.1% to 1%): Gynecomastia
[Ref]
Hepatic
Very rare (less than 0.01%): Hepatitis,
jaundice, hepatic enzymes increased
[Ref]
Increased hepatic enzymes were mostly consistent with cholestasis.
Some cases of hepatitis, jaundice, and/or hepatic enzyme elevations were severe enough to require hospitalization; however, the association with this drug was uncertain in most cases.
[Ref]
Hypersensitivity
References
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. "Product Information. Norvasc (amlodipine)." Pfizer US Pharmaceuticals, New York, NY.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the
FDA.
