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Sensipar (Cinacalcet) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sensipar (Cinacalcet) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (190)
Death (19)
Disability (3)

Reports by Reaction Type

Hospitalisation (19)Death (16)Enteral Nutrition (14)Blood Parathyroid Hormone Increased (13)Nausea (12)Gastrointestinal Tube Insertion (10)Dyspnoea (9)Convulsion (9)Blood Calcium Decreased (8)Tremor (8)Fall (7)Calciphylaxis (7)

Below are a few examples of reports where side effects / adverse reactions may be related to Sensipar (Cinacalcet). For a complete list or a specific selection of reports, please use the links above.

Possible Sensipar side effects in 66 year old male

Reported by a physician from Australia on 2012-08-23

Patient: 66 year old male

Reactions: Abdominal Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Placebo
    Dosage: unk unk, qd
    Administration route: Oral
    Indication: Hyperparathyroidism Secondary
    Start date: 2012-01-17
    End date: 2012-05-08

Sensipar
    Dosage: 60 mg, unk
    Start date: 2012-05-22
    End date: 2012-06-05

Sensipar
    Dosage: 30 mg, qd
    Indication: Hyperparathyroidism Secondary
    Start date: 2012-05-08
    End date: 2012-05-21

Sensipar
    Dosage: 90 mg, unk
    Start date: 2012-06-06
    End date: 2012-07-20

Other drugs received by patient: Aspirin; Omeprazole; Prednisone TAB; Clopidegrel; Mycophenolate Mofetil (Cellcept); Tacrolimus



Possible Sensipar side effects in 68 year old female

Reported by a physician from United States on 2012-08-21

Patient: 68 year old female

Reactions: Abasia, Musculoskeletal Pain, Muscular Weakness, Rash, Tooth Disorder, Blood Parathyroid Hormone Increased

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in male

Reported by a pharmacist from United States on 2012-08-20

Patient: male

Reactions: Gastrostomy Tube Insertion, Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in 64 year old female

Reported by a physician from United States on 2012-08-14

Patient: 64 year old female

Reactions: Metastatic Neoplasm

Drug(s) suspected as cause:
Aranesp
    Dosage: unk
    Start date: 2011-12-07

Aranesp

Aranesp
    Dosage: unk
    Indication: Anaemia
    Start date: 2009-01-01

Sensipar
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-05

Other drugs received by patient: Claritin / 00413701 /; Zocor; Fluticasone Propionate; Lasix; Miralax / 00754501 /; Synthroid; Ambien; Allopurinol; Nephrocaps / 01801401 /; Wellbutrin; Tylenol (Caplet); Atacand; Nexium; Singulair; Xopenex; Coreg



Possible Sensipar side effects in

Reported by a physician from United States on 2012-08-14

Patient:

Reactions: Convulsion

Drug(s) suspected as cause:
Sensipar

Sensipar
    Indication: Product Used FOR Unknown Indication



Possible Sensipar side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 65 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Sensipar
    Dosage: unk
    Administration route: Oral
    Indication: Blood Calcium
    Start date: 2011-01-01
    End date: 2012-02-01

Sensipar
    Indication: Blood Phosphorus



Possible Sensipar side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08

Patient: female

Reactions: Anaphylactic Reaction

Drug(s) suspected as cause:
Sensipar
    Indication: Renal Failure Chronic

Sensipar
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Hyperparathyroidism Secondary



Possible Sensipar side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: female

Reactions: Anaphylactic Reaction

Drug(s) suspected as cause:
Sensipar
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Hyperparathyroidism Secondary

Sensipar
    Indication: Renal Failure Chronic



Possible Sensipar side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: female

Reactions: Neck Pain, Musculoskeletal Pain, Headache

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: female

Reactions: Eye Swelling

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient:

Reactions: Convulsion

Drug(s) suspected as cause:
Sensipar

Sensipar
    Indication: Product Used FOR Unknown Indication



Possible Sensipar side effects in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 58 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in 56 year old male

Reported by a pharmacist from United States on 2012-07-30

Patient: 56 year old male

Reactions: Constipation

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in

Reported by a pharmacist from United States on 2012-07-30

Patient:

Reactions: Gastrointestinal Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in male

Reported by a physician from United States on 2012-07-27

Patient: male

Reactions: Therapeutic Response Decreased

Drug(s) suspected as cause:
Epogen
    Dosage: 11000 iu, 3 times/wk
    Indication: Dialysis
    Start date: 2011-01-01

Epogen
    Dosage: 23100 iu, 3 times/wk

Sensipar
    Dosage: 180 mg, qd
    Indication: Hyperparathyroidism Secondary

Other drugs received by patient: Atenolol; Renvela; Hectorol; Venofer; Sertraline Hydrochloride



Possible Sensipar side effects in

Reported by a physician from United States on 2012-07-27

Patient:

Reactions: Calciphylaxis

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in

Reported by a physician from United States on 2012-07-27

Patient:

Reactions: Calciphylaxis

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in

Reported by a physician from United States on 2012-07-27

Patient:

Reactions: Calciphylaxis

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient:

Reactions: Calciphylaxis

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in 66 year old male

Reported by a physician from Australia on 2012-07-26

Patient: 66 year old male

Reactions: Abdominal Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Placebo
    Dosage: unk unk, qd
    Administration route: Oral
    Indication: Hyperparathyroidism Secondary
    Start date: 2012-01-17
    End date: 2012-05-08

Sensipar
    Dosage: 90 mg, unk
    Start date: 2012-06-06
    End date: 2012-07-20

Sensipar
    Dosage: 30 mg, qd
    Indication: Hyperparathyroidism Secondary
    Start date: 2012-05-08
    End date: 2012-05-21

Sensipar
    Dosage: 60 mg, unk
    Start date: 2012-05-22

Other drugs received by patient: Omeprazole; Prednisone; Clopidogrel; Cellcept; Aspirin; Tacrolimus



Possible Sensipar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient:

Reactions: Calciphylaxis

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient:

Reactions: Calciphylaxis

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24

Patient:

Reactions: Dysphagia

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in

Reported by a physician from United States on 2012-07-23

Patient:

Reactions: Convulsion

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: female

Reactions: Breast Mass

Drug(s) suspected as cause:
Sensipar
    Dosage: unk
    Indication: Hyperparathyroidism Secondary

Tamoxifen Citrate
    Dosage: unk



Possible Sensipar side effects in 79 year old male

Reported by a physician from United States on 2012-07-23

Patient: 79 year old male

Reactions: Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Sensipar
    Dosage: 60 mg, qd
    Start date: 2012-02-12

Sensipar
    Dosage: unk

Sensipar
    Dosage: 30 mg, qd
    Indication: Renal Failure Chronic
    Start date: 2011-04-19



Possible Sensipar side effects in 72 year old female

Reported by a physician from United States on 2012-07-20

Patient: 72 year old female

Reactions: Malaise, Nausea, Abnormal Sensation in Eye, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sensipar



Possible Sensipar side effects in

Reported by a pharmacist from United States on 2012-07-18

Patient:

Reactions: Gastrointestinal Tube Insertion

Drug(s) suspected as cause:
Sensipar
    Dosage: 60 mg, qd
    Administration route: Oral
    Indication: Renal Failure Chronic

Sensipar
    Indication: Hyperparathyroidism Secondary



Possible Sensipar side effects in

Reported by a physician from United States on 2012-07-18

Patient:

Reactions: Vomiting, Osteoporosis, Nausea, Hypocalcaemia, General Physical Health Deterioration, Bone Density Decreased, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sensipar
    Dosage: 60 mg, bid
    Indication: Hyperparathyroidism Primary

Sensipar
    Dosage: 90 mg, qd



Possible Sensipar side effects in 84 year old female

Reported by a physician from Australia on 2012-07-18

Patient: 84 year old female

Reactions: Deep Vein Thrombosis

Drug(s) suspected as cause:
Sensipar

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