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Cartia XT (Diltiazem Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies.

The following table presents the most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving diltiazem hydrochloride extended-release capsule (once-a-day dosing) product up to 360 mg with rates in placebo patients shown for comparison.

Diltiazem Hydrochloride Extended-release Capsule (once-a-day) Placebo-controlled Angina and Hypertension Trials Combined

Adverse Reactions

Diltiazem Extended-release
Capsule (once-a-day)
n=607

Placebo
n=301

Headache

5.4%

5.0%

Dizziness

3.0%

3.0%

Bradycardia

3.3%

1.3%

AV Block
       First-Degree


 3.3%
 
0.0%

Edema

2.6%

1.3%

ECG Abnormality

1.6%

1.7

Asthenia

1.8%

1.7%

In clinical trials of diltiazem hydrochloride extended-release capsules (Once A Day Dosage), diltiazem hydrochloride tablets and diltiazem hydrochloride extended-release capsules involving over 3200 patients, the most common events (i.e., greater than 1%) were edema (4.6%), headache (4.6%), dizziness (3.5%), asthenia (2.6%), first-degree AV block (2.4%), bradycardia (1.7%), flushing (1.4%), nausea (1.4%), and rash (1.2%).

In addition, the following events were reported infrequently (less than 1%) in angina or hypertension trials:

Cardiovascular: Angina, arrhythmia, AV block (second- or third-degree), bundle branch block, congestive heart failure, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.

Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor.

Gastrointestinal: Anorexia, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase (see WARNINGS, Acute Hepatic Injury ), thirst, vomiting, weight increase.

Dermatological: Petechiae, photosensitivity, pruritus, urticaria.

Other: Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties.

The following postmarketing events have been reported infrequently in patients receiving diltiazem: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), purpura, retinopathy, myopathy, and thrombocytopenia. In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients. A number of well-documented cases of generalized rash, some characterized as leukocytoclastic vasculitis, have been reported. However, a definitive cause and effect relationship between these events and diltiazem therapy is yet to be established.



REPORTS OF SUSPECTED CARTIA XT SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Cartia XT. The information is not vetted and should not be considered as verified clinical evidence.

Possible Cartia XT side effects / adverse reactions in 79 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-16

Patient: 79 year old female

Reactions: Agitation, Restless Legs Syndrome, Orthostatic Hypotension, Disorientation, Pharyngeal Oedema, Dyspepsia, Palpitations, Dizziness, Feeling of Body Temperature Change, Nervousness, Muscle Spasms, Blood Pressure Increased, Nightmare, Nausea, Hypotension, Tremor, Anxiety, Heart Rate Decreased, Diarrhoea, Arthralgia

Suspect drug(s):
Mirtazapine
    Indication: Product Used FOR Unknown Indication

Micardis
    Indication: Product Used FOR Unknown Indication

Cardura
    Indication: Product Used FOR Unknown Indication

Macrobid
    Indication: Product Used FOR Unknown Indication

Prozac
    Indication: Product Used FOR Unknown Indication

Cipro
    Indication: Product Used FOR Unknown Indication

Norvasc
    Indication: Product Used FOR Unknown Indication

Vasotec
    Indication: Product Used FOR Unknown Indication

Diovan
    Indication: Product Used FOR Unknown Indication

Diltiazem
    Indication: Product Used FOR Unknown Indication

Tiazac
    Indication: Product Used FOR Unknown Indication

Zoloft
    Indication: Product Used FOR Unknown Indication

Cymbalta
    Indication: Product Used FOR Unknown Indication

Celebrex
    Indication: Product Used FOR Unknown Indication

Fentanyl
    Indication: Product Used FOR Unknown Indication

Naproxen
    Indication: Product Used FOR Unknown Indication

Wellbutrin XL
    Indication: Product Used FOR Unknown Indication

Levaquin
    Indication: Product Used FOR Unknown Indication

Tekturna
    Indication: Product Used FOR Unknown Indication

Toprol-XL
    Indication: Product Used FOR Unknown Indication

Cartia XT
    Indication: Product Used FOR Unknown Indication

Paxil
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Effexor XR; Protonix



Possible Cartia XT side effects / adverse reactions in 82 year old female

Reported by a consumer/non-health professional from United States on 2011-11-29

Patient: 82 year old female weighing 45.5 kg (100.1 pounds)

Reactions: Fatigue, Somnolence, Asthenia

Suspect drug(s):
Cartia XT
    Dosage: 120mg per day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-02-17

Digoxin
    Dosage: .25mg per day
    Administration route: Oral
    Indication: Atrial Fibrillation



Possible Cartia XT side effects / adverse reactions in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-04-10

Patient: 49 year old female weighing 98.0 kg (215.5 pounds)

Reactions: Eyelid Oedema, Swelling Face, Drug Ineffective, Somnolence, Chest Pain, Disturbance in Attention, Dizziness, Hypertension, Asthenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Lisinopril
    Dosage: 20 mg, 1 d, unknown
    Indication: Hypertension
    Start date: 2008-03-01
    End date: 2008-03-01

Cartia XT
    Dosage: 180 mg, 1 d, oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-03-01
    End date: 2008-03-01

Effexor XR
    Dosage: 75 mg (75 mg, 1 in 1 d), oral; 150 mg, 1 in 1 d, oral; 225 mg (225 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Depression
    Start date: 2008-01-01
    End date: 2008-01-01

Effexor XR
    Dosage: 75 mg (75 mg, 1 in 1 d), oral; 150 mg, 1 in 1 d, oral; 225 mg (225 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Depression
    Start date: 2008-03-01
    End date: 2008-03-01

Effexor XR
    Dosage: 75 mg (75 mg, 1 in 1 d), oral; 150 mg, 1 in 1 d, oral; 225 mg (225 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Depression
    Start date: 2008-01-01
    End date: 2008-01-01

Other drugs received by patient: Cardira XL (Doxazosin Mesilate)



See index of all Cartia XT side effect reports >>

Drug label data at the top of this Page last updated: 2011-09-30

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