Duactin Side effects

• Side effects of Duactin in details
• Duactin contraindications
• Duactin reviews

What are the possible side effects of Duactin?

Get emergency medical help if you have signs of an allergic reaction to Duactin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, when you first start taking Duactin, 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 Duactin side effects may include:

• dizziness;

• feeling tired;

• stomach pain, nausea; or

• flushing (warmth, redness, or tingly feeling).

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.

Side effects of Duactin in details

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Duactin has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with Duactin was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with Duactin were of mild or moderate severity. In controlled clinical trials directly comparing Duactin (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of Duactin because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below. The incidence (%) of side effects that occurred in a dose related manner are as follows:

Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with Duactin treatment as shown in the following table:

The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:

Cardiovascular

arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis.

Central And Peripheral Nervous System

hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.

Gastrointestinal

anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.

General

allergic reaction, asthenia, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.

Musculoskeletal System

arthralgia, arthrosis, muscle cramps,These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.

What is the most important information I should know about Duactin?

• Duactin may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Duactin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Duactin may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
• If you are taking Duactin for angina, it will not relieve the pain of an acute attack if it is taken at the time of an acute attack. It prevents or reduces the number of angina attacks only if you take it on regular schedule.
• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
• While you are using Duactin, it is important to brush and floss your teeth carefully to reduce swelling and tenderness of your gums.
• Although rare, Duactin has been known to increase chest pain and increase the risk of a heart attack, especially in patients with severe heart disease.
• Lab tests, including blood pressure checks, may be performed while you use Duactin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Duactin with caution in the ELDERLY; they may be more sensitive to its effects.
• Duactin should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Duactin while you are pregnant. It is not known if Duactin is found in breast milk. Do not breast-feed while taking Duactin.

Duactin contraindications

Before taking Duactin, 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 Duactin.

If you are being treated for high blood pressure, keep using this medication 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.

Duactin 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 Duactin or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

References

1. European Chemicals Agency - ECHA. "3,5-Pyridinedicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
2. HSDB. "AMLODIPINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
3. NCIt. "Amlodipine: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology