Orthostatic symptoms and conditions

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

A few weeks ago I reported many of the side effects so many of you have reported on. After several blood tests with my endocronologist, results came back normal. I have now been off Singulair for about five weeks and have noted only one improvement thus far: less headaches (especially after drinking alcohol--that being defined as one or two beers/glasses of wine. I think this has to do with less constriction of blood vessels in the brain).

I'm returning to my cardiologist next week. I'm thinking I may have what is called Postural Orthostatic Tachycardia Syndrome which can be described as a periodic low blood pressure disease that causes dizziness, faintness, ect. Many other symptoms of this disease have been mentioned on this site (including Shy-Drager Syndrome which is most scary). Doctors don't really know what brings on Pots but one suspicion is viral/bacterial or drug induced...jury is completely out on this, however).

Most notable is a sudden change in bp after stooping and standing up--bp drops, palpitations begin, extreme fatigue generally follows.

A table tilt test should help with the diagnosis.

Question: Are any of you familiar with Pots and/or have any of you experienced similar symptoms?

Thanks.

Fortuna

I have to say that I am stunned, and curious, about the numerous claims of weight gain induced by Toprol XL. I have been taking 100 mg once a day for the past 9 months and I havent gained an ounce- I am 5'6" and I weigh 110 lbs. I have Postural Orthostatic Tachycardia Syndrome and this medicine has improved my life dramatically. I cant say enough good things about it. I am shocked to read these postings.