Combination drug symptoms and conditions

I am a 60 year old male. I have been on high dose Niacin for more than 12 years. 2 years ago I started taking the combination drug, Advicor. (Lipitor and Niacin) Up until this point, there were no side affects with the Niacin other than occasional flushing. Since starting on the Advicor I have noticed a gradual weakening of muscles, and occasional joint pain. I have recently increased my exercise, thinking this was part of the aging process. I have not worked out consistently for 2 years. I have not noticed much improvement in my conditioning in the past 3 weeks, and have in fact noticed my quadriceps feel as though there is a buildup of lactic acid. I also notice my heart rate does not climb very high before my perceived exertion is above 50%. I did a fitness evaluation today at the health club I go to. The trainer mentioned that he hears the same thing from a lot of people who are on Lipitor. He went on to say, there heart rate is usually 20 bpm lower when on the drug. I am going to be talking with my physician to see about getting off Advicor and going back to just the Niacin. I will increase my exercise and more closely watch my diet. I want to thank the folks who have posted.

I have read everyone's symptoms that have written their concerns on this website and I want to recommend that you contact the U.S. Food and Drug Administration website at: www.fda.gov and it will give you all the information you need on the side effects of this drug.

Believe me, many of the symptoms you have all described are on their list under the section that I browsed through when I looked up Lisinopril/HCTZ or ZESTORETIC (the generic kind of this drug).

This what I found:

ADVERSE REACTIONS

ZESTORETIC has been evaluated for safety in 930 patients including 100 patients treated for 50 weeks or more.

In clinical trials with ZESTORETIC no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with lisinopril or hydrochlorothiazide.

The most frequent clinical adverse experiences in controlled trials (including open label extensions) with any combination of lisinopril and hydrochlorothiazide were: dizziness (7.5%), headache (5.2%), cough (3.9%), fatigue (3.7%) and orthostatic effects (3.2%) all of which were more common than in placebo-treated patients. Generally, adverse experiences were mild and transient in nature, but see WARNINGS regarding angioedema and excessive hypotension or syncope. Discontinuation of therapy due to adverse effects was required in 4.4% of patients principally because of dizziness, cough, fatigue and muscle cramps.

Adverse experiences occurring in greater than one percent of patients treated with lisinopril plus hydrochlorothiazide in controlled clinical trials are shown below.

Table Percent of Patients in Controlled Studies

(For a more detailed breakdown of this chart, pls. check the fda website)

Incidence (discontinuation)

Dizziness 7.5
Headache 5.2
Cough 3.9
Fatigue 3.7
Orthostatic Effects 3.2
Diarrhea 2.5
Nausea 2.2
Upper Respiratory Infection 2.2
Muscle Cramps 2.0
Asthenia 1.8
Paresthesia 1.5
Hypotension 1.4
Vomiting 1.4
Dyspepsia 1.3
Rash 1.2
Impotence 1.2

Clinical adverse experiences occurring in 0.3% to 1.0% of patients in controlled trials and rarer, serious, possibly drug-related events reported in marketing experience are listed below:

Body as a Whole: Chest pain, abdominal pain, syncope, chest discomfort, fever, trauma, virus infection. Cardiovascular: Palpitation, orthostatic hypotension. Digestive: Gastrointestinal cramps, dry mouth, constipation, heartburn. Musculoskeletal: Back pain, shoulder pain, knee pain, back strain, myalgia, foot pain. Nervous/Psychiatric: Decreased libido, vertigo,
depression, somnolence. Respiratory: Common cold, nasal congestion, influenza, bronchitis, pharyngeal pain, dyspnea, pulmonary congestion, chronic sinusitis, allergic rhinitis, pharyngeal discomfort. Skin: Flushing, pruritus, skin inflammation, diaphoresis, cutaneous pseudolymphoma. Special Senses: Blurred vision, tinnitus, otalgia. Urogenital: Urinary tract infection.

Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely. (See WARNINGS.)
In rare cases, intestinal angioedema has been reported in post marketing experience.

Hypotension: In clinical trials, adverse effects relating to hypotension occurred as follows: hypotension (1.4%), orthostatic hypotension (0.5%), other orthostatic effects (3.2%). In addition syncope occurred in 0.8% of patients. (See WARNINGS.)

Cough: See PRECAUTIONS - Cough.

I found this website to be helpful information in trying to find out more about the side effects I have been experiencing after taking this drug. I also wrote in to the U.S. Food and Drug Adminstration with my concerns to see what we can do to get it off the market or have it improved.

There is alot more information about the drug and its generic brand as well, but I thought this was important to put on this website. Hope this helps!

Martha