Zemplar
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Zemplar Injection
Zemplar Side Effects Center
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 is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Zemplar Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your vitamin D and calcium levels too high. Tell your doctor immediately if any of these unlikely but serious effects of too much vitamin D/calcium occur: constipation, drowsiness, dry mouth, muscle/bone/joint pain, metallic taste in mouth, weakness, vomiting.
Tell your doctor immediately if any of these rare but serious side effects of very high vitamin D levels occur: loss of appetite, unusual weight loss, eye pain/redness/sensitivity to light, severe runny nose, stomach/abdominal pain.
Tell your doctor right away if you have any serious side effects, including: dizziness, fast/irregular/pounding heartbeat, swelling hands/ankles/feet, severe mental/mood changes (e.g., agitation, confusion), easy bleeding/bruising, bloody/tarry stool, vomit that looks like coffee grounds.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Zemplar (Paricalcitol Injection Fliptop Vial)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zemplar FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Zemplar has been evaluated for safety in clinical studies in 609 CKD Stage 5 patients. In four, placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in 6.5% of 62 patients treated with Zemplar (dosage titrated as tolerated, see CLINICAL PHARMACOLOGY - Clinical Studies) and 2.0% of 51 patients treated with placebo for 1 to 3 months. Adverse events occurring in the Zemplar group at a frequency of 2% or greater and with an incidence greater than that in the placebo group, regardless of causality, are presented in the following table:
Adverse Event Incidence Rates for All Treated Patients In
All Placebo-Controlled Studies
| Adverse Event | Zemplar (n = 62) % | Placebo (n = 51) % |
| Overall | 71 | 78 |
| Cardiac Disorders | ||
| Palpitations | 3.2 | 0.0 |
| Gastrointestinal Disorders | ||
| Dry Mouth | 3.2 | 2.0 |
| Gastrointestinal Hemorrhage | 4.8 | 2.0 |
| Nausea | 12.9 | 7.8 |
| Vomiting | 8.1 | 5.9 |
| General Disorders and Administration Site Conditions | ||
| Chills | 4.8 | 2.0 |
| Edema | 6.5 | 0.0 |
| Malaise | 3.2 | 0.0 |
| Pyrexia | 4.8 | 2.0 |
| Infections and Infestations | ||
| Influenza | 4.8 | 3.9 |
| Pneumonia | 4.8 | 0.0 |
| Sepsis | 4.8 | 2.0 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Arthralgia | 4.8 | 3.9 |
A patient who reported the same medical term more than once was counted only once for that medical term.
Safety parameters (changes in mean Ca, P, Ca × P) in an open-label safety study up to 13 months in duration support the long-term safety of Zemplar in this patient population (see Clinical Studies).
Other Adverse Reactions Observed During Clinical Evaluation of Zemplar Injection (paricalcitol injection fliptop vial)
The following adverse reactions, with a causal relationship to Zemplar, occurred in < 2% of the Zemplar treated patients in the above double-blind, placebo-controlled clinical trial data set. In addition, the following also includes adverse reactions reported in Zemplar-treated patients who participated in other studies (non placebo-controlled), including double-blind, active-controlled and open-label studies:
Blood and Lymphatic System Disorders
Cardiac Disorders
Arrhythmia, atrial flutter, cardiac arrest
Ear and Labyrinth Disorders
Ear discomfort
Endocrine Disorders
Hyperparathyroidism, hypoparathyroidism
Eye Disorders
Conjunctivitis, glaucoma, ocular hyperemia
Gastrointestinal Disorders
Abdominal discomfort, constipation, diarrhea, dysphagia, gastritis, intestinal ischemia, rectal hemorrhage
General Disorders and Administration Site Conditions
Asthenia, chest discomfort, chest pain, condition aggravated, edema peripheral, fatigue, feeling abnormal, gait disturbance, injection site extravasation, injection site pain, pain, swelling, thirst
Infections and Infestations
Nasopharyngitis, upper respiratory tract infection, vaginal infection
Investigations
Aspartate aminotransferase increased, bleeding time prolonged, heart rate irregular, laboratory test abnormal, weight decreased
Metabolism and Nutrition Disorders
Decreased appetite, hypercalcemia, hyperkalemia, hyperphosphatemia, hypocalcemia
Musculoskeletal and Connective Tissue Disorders
Joint stiffness, muscle twitching, myalgia Neoplasms Benign,
Malignant and Unspecified
Breast cancer
Nervous System Disorders
Cerebrovascular accident, dizziness, dysgeusia, headache, hypoesthesia, myoclonus, paresthesia, syncope, unresponsive to stimuli
Psychiatric Disorders
Agitation, confusional state, delirium, insomnia, nervousness, restlessness
Reproductive System and Breast Disorders
Breast pain, erectile dysfunction
Respiratory, Thoracic and Mediastinal Disorders
Cough, dyspnea, orthopnea, pulmonary edema, wheezing
Skin and Subcutaneous Tissue Disorders
Alopecia, blister, hirsutism, night sweats, rash pruritic, pruritus, skin burning sensation
Vascular Disorders
Additional Adverse Events Reported During Post-marketing Experience
Allergic reactions, such as rash, urticaria, and angioedema (including laryngeal edema) have been reported.
Read the entire FDA prescribing information for Zemplar (Paricalcitol Injection Fliptop Vial) »
Additional Zemplar Injection Information
Zemplar Injection - User Reviews
Zemplar Injection User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Zemplar Injection sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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