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Livalo (Pitavastatin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Livalo (Pitavastatin) 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 (14)
Life Threatening Events (18)
Disability (9)

Reports by Reaction Type

Rhabdomyolysis (28)Myalgia (21)Blood Creatine Phosphokinase Increased (17)Back Pain (12)Pain in Extremity (10)Liver Disorder (9)Alanine Aminotransferase Increased (9)Arthralgia (9)Aspartate Aminotransferase Increased (9)Hepatic Function Abnormal (8)Interstitial Lung Disease (8)Pneumonia (8)

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

Possible Livalo side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-22

Patient:

Reactions: Liver Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Amaryl
    Administration route: Oral

Aspirin
    Administration route: Oral

Januvia
    Administration route: Oral

Livalo
    Administration route: Oral

Miglitol
    Administration route: Oral

Mucosta
    Administration route: Oral

Pitavastatin Calcium
    Administration route: Oral

Plavix
    Administration route: Oral



Possible Livalo side effects in 75 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 75 year old female

Reactions: Myalgia, Nasopharyngitis, Pharyngeal Haemorrhage, Blood Cholesterol Increased, Dizziness, Blood Triglycerides Increased, Hypoaesthesia, Epistaxis

Drug(s) suspected as cause:
Effient
    Dosage: 5 mg;1x;po
    Administration route: Oral
    Indication: Coronary Artery Disease

Livalo
    Dosage: 2 mg;1x;po
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2012-04-10

Other drugs received by patient: Aspirin



Possible Livalo side effects in 87 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 87 year old female, weighing 55.8 kg (122.7 pounds)

Reactions: Abdominal Pain, Back Pain, Vomiting, Haemoptysis, Nausea, Neck Pain

Drug(s) suspected as cause:
Livalo

Other drugs received by patient: Metoprolol Tartrate; Hydrochlorothiazide; Janumet; Glimepiride; Lotrel; Synthroid



Possible Livalo side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 67 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Nervous System Disorder, Headache, Muscle Tightness, Muscle Spasms

Drug(s) suspected as cause:
Livalo



Possible Livalo side effects in 68 year old female

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

Patient: 68 year old female, weighing 63.2 kg (139.0 pounds)

Reactions: Blood Pressure Increased, Back Pain, Asthma, Dyspnoea, Cardiac Stress Test Abnormal, Hypotension, Constipation, Chest X-RAY Abnormal, Anxiety, Catheterisation Cardiac, Hypopnoea, Chest Pain, Oral Disorder, Pleural Effusion, Depression

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Livalo

Other drugs received by patient: Lisinopril; Clonidine HCL; Aspirin; Fosamax; Allegra-D 12 Hour; Vitamin-Mineral Compound TAB; Premarin; Fish OIL; Fexofenadine HCL; ...; Zolpidem Tartrate; Nitroglycerin; Fluticasone Propionate; Albuterol Sulfate; Vitamin D; Synthroid; Pneumococcal Vaccine; Atenolol



Possible Livalo side effects in 61 year old female

Reported by a physician from Japan on 2012-08-02

Patient: 61 year old female, weighing 47.0 kg (103.4 pounds)

Reactions: Extranodal Marginal Zone B-Cell Lymphoma (Malt Type), Helicobacter Infection

Drug(s) suspected as cause:
Livalo

Other drugs received by patient: Calcium W / Magnesium / Vitamin D; Investigational Drug; Colonel; Laxoberon; Magnesium Oxide



Possible Livalo side effects in 64 year old male

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

Patient: 64 year old male, weighing 102.1 kg (224.5 pounds)

Reactions: Myalgia, Haematochezia, Back Pain, Abasia, Condition Aggravated, Colitis

Drug(s) suspected as cause:
Livalo

Other drugs received by patient: Onglyza; Fenofibrate; Welchol; Lovaza



Possible Livalo side effects in 67 year old male

Reported by a physician from Japan on 2012-08-02

Patient: 67 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Drug-Induced Liver Injury, Pyrexia, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Allegra
    Dosage: 60 mg; bid; po
    Administration route: Oral
    End date: 2012-05-25

Disopyramide
    Dosage: 150 mg; 1x';po
    Administration route: Oral
    Start date: 2006-08-01

Famotidine
    Dosage: 20 mg; bid; po
    Administration route: Oral
    Start date: 2006-08-01

Livalo
    Indication: Dyslipidaemia

Mucodyne (Carbocisteine)
    Dosage: 500 mg; tid; po
    Administration route: Oral
    End date: 2012-05-25

Norvasc
    Dosage: 5 mg; 1x; po
    Administration route: Oral
    Start date: 2006-08-01

Shakuyakukanzoto (Shakuyakukanzoto)
    Dosage: 5 gm; bid; po
    Administration route: Oral
    End date: 2012-05-25

Ticlopidine Hydrochloride
    Dosage: 100 mg; bid; po
    Administration route: Oral
    Start date: 2006-08-01

Other drugs received by patient: Aspirin



Possible Livalo side effects in 63 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-02

Patient: 63 year old male

Reactions: Alanine Aminotransferase Increased, Muscular Weakness, Joint Stiffness

Drug(s) suspected as cause:
Livalo

Other drugs received by patient: Bisoprolol W / Hydrochlorothiazide / 01166101 /; Ibuprofen



Possible Livalo side effects in 55 year old male

Reported by a pharmacist from Japan on 2012-08-02

Patient: 55 year old male, weighing 99.6 kg (219.1 pounds)

Reactions: Blood Urea Increased, Rhabdomyolysis, Blood Creatinine Increased, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Livalo
    Dosage: 1 mg;1x;po
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2012-04-11
    End date: 2012-07-01

Nesina
    Dosage: 25 mg;1x;po
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-04-12
    End date: 2012-06-29

Plavix
    Dosage: 75 ng;1x;po
    Administration route: Oral
    Indication: Acute Myocardial Infarction
    Start date: 2012-04-10
    End date: 2012-06-09

Other drugs received by patient: Bisoprolol Fumarate; Exforge; Aspirin; Lansoprazole



Possible Livalo side effects in 68 year old female

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

Patient: 68 year old female, weighing 63.2 kg (139.0 pounds)

Reactions: Back Pain, Blood Pressure Increased, Asthma, Pneumonia, Pain in Extremity, Headache, Coronary Arterial Stent Insertion, Constipation, Anxiety, Fatigue, Hypopnoea, Oral Disorder, Pleural Effusion, Depression, Asthenia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Livalo

Other drugs received by patient: Pneumococcal Vaccine; Premarin; Fish OIL; Zolpidem Tartrate; Nitroglycerin; Aspirin; Vitamin-Mineral Compound TAB; Atenolol; Fexofenadine HCL; Vitamin D; Synthroid; Clonidine; Lisinopril; Fosamax; Advair; Albuterol Sulfate; Allegra-D 12 Hour



Possible Livalo side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Ambien CR

Amoxicillin
    Dosage: 0.5, qd

Arthrotec
    Administration route: Oral

Biaxin

Cefzil

Lipitor
    Administration route: Oral

Livalo

Lortab

Oxacillin Sodium

PCE

Pravachol

Provigil

Sulfamethoxazole

Ultram

Zetia
    Administration route: Oral

Zocor
    Administration route: Oral



Possible Livalo side effects in 76 year old female

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

Patient: 76 year old female

Reactions: Parkinson's Disease

Drug(s) suspected as cause:
Livalo
    Dosage: for a long time
    Administration route: Oral

Orencia
    Start date: 2012-04-24



Possible Livalo side effects in 76 year old female

Reported by a physician from Japan on 2012-07-30

Patient: 76 year old female

Reactions: Parkinson's Disease

Drug(s) suspected as cause:
Livalo
    Dosage: for a long time
    Administration route: Oral

Orencia
    Start date: 2012-04-24



Possible Livalo side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: male, weighing 77.1 kg (169.6 pounds)

Reactions: Myalgia, Arthralgia, Tendon Rupture, Insomnia, NO Therapeutic Response, Rotator Cuff Syndrome, Gait Disturbance, Fall, Neuralgia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Livalo



Possible Livalo side effects in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: 69 year old male

Reactions: Wrong Technique in Drug Usage Process, Stent Placement, Post Procedural Haemorrhage, Large Intestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Livalo
    Dosage: 0.5 df; po, 2 mg; po
    Administration route: Oral
    Start date: 2011-10-01
    End date: 2011-12-01

Livalo
    Dosage: 0.5 df; po, 2 mg; po
    Administration route: Oral
    Start date: 2011-12-01

Other drugs received by patient: Uloric; Aricept; Toprol-XL; Coumadin; Plavix; Aspirin; Lovenox



Possible Livalo side effects in 64 year old male

Reported by a physician from Japan on 2012-07-17

Patient: 64 year old male

Reactions: Nightmare, Contusion, Haemorrhage, Pain in Extremity, Delirium

Drug(s) suspected as cause:
Allopurinol
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Hyperuricaemia
    Start date: 2010-05-28

Livalo
    Dosage: once a day
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-02-23

Loxonin
    Dosage: unk
    Administration route: Oral
    Indication: Pain
    Start date: 2011-01-28

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    Indication: Intervertebral Disc Protrusion
    Start date: 2010-12-03
    End date: 2012-05-24

Rezaltas
    Dosage: once a day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-04-21

Selbex
    Dosage: unk
    Administration route: Oral
    Indication: Gastric Mucosal Lesion
    Start date: 2010-06-03

Other drugs received by patient: Trichlormethiazide; Maglax



Possible Livalo side effects in 67 year old male

Reported by a physician from Japan on 2012-07-12

Patient: 67 year old male

Reactions: Hepatic Function Abnormal, C-Reactive Protein Increased, Gamma-Glutamyltransferase Increased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Allegra
    Dosage: po
    Administration route: Oral

Disopyramide
    Dosage: 150 mg; 1x; po
    Administration route: Oral
    Start date: 2006-08-01

Famotidine
    Dosage: po
    Administration route: Oral
    Start date: 2006-08-01

Livalo
    Dosage: 1 mg; 1x; po, 4 mg; 1x; po, 1 mg; 1x; po
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2012-05-15
    End date: 2012-05-18

Livalo
    Dosage: 1 mg; 1x; po, 4 mg; 1x; po, 1 mg; 1x; po
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2012-05-18

Livalo
    Dosage: 1 mg; 1x; po, 4 mg; 1x; po, 1 mg; 1x; po
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2006-08-01
    End date: 2012-05-14

Mucodyne (Carbocisteine)
    Dosage: 500 mg; tid; po
    Administration route: Oral

Nasonex
    Dosage: nas

Norvasc
    Dosage: 5 mg; 1x; po
    Administration route: Oral
    Start date: 2006-08-01

Shakuyakukanzoto (Shakuyakukanzoto)
    Dosage: po
    Administration route: Oral

Ticlopidine HCL
    Dosage: 100 mg; 1x; po
    Administration route: Oral
    Start date: 2006-08-01



Possible Livalo side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: 69 year old female

Reactions: Asthma, Headache, Constipation, Chest X-RAY Abnormal, Fatigue, Chest Pain, Pleural Effusion, Back Pain, Blood Pressure Increased, Pneumonia, Dyspnoea, Pain in Extremity, Anxiety, Hypopnoea, Oral Disorder, Feeling Abnormal, Asthenia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Livalo

Other drugs received by patient: .; Pneumococcal Vaccine



Possible Livalo side effects in 51 year old female

Reported by a physician from Japan on 2012-06-29

Patient: 51 year old female, weighing 57.0 kg (125.4 pounds)

Reactions: Myalgia, Blood Urine Present, Joint Swelling, Arthralgia, Proteinuria, Microscopic Polyangiitis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Livalo
    Dosage: 2 mg;1x;po
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2011-07-20
    End date: 2011-08-01

Zetia
    Dosage: 10 mg;1x;po
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 2011-12-01
    End date: 2012-01-01



Possible Livalo side effects in 76 year old female

Reported by a physician on 2012-06-29

Patient: 76 year old female

Reactions: Blood Creatine Phosphokinase Increased

Drug(s) suspected as cause:
Livalo



Possible Livalo side effects in 48 year old female

Reported by a pharmacist from Japan on 2012-06-29

Patient: 48 year old female

Reactions: Myalgia, Blood Creatine Phosphokinase Increased, Myoglobin Blood Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Livalo



Possible Livalo side effects in 76 year old female

Reported by a physician from Japan on 2012-06-26

Patient: 76 year old female

Reactions: Parkinsonism

Drug(s) suspected as cause:
Livalo
    Dosage: for a long time
    Administration route: Oral

Orencia
    Start date: 2012-04-24



Possible Livalo side effects in female

Reported by a physician from United States on 2012-06-26

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Ambien CR
    Dosage: unk

Amoxicillin
    Dosage: 0.5 unk, 1x/day

Arthrotec
    Dosage: unk
    Administration route: Oral

Biaxin
    Dosage: unk

Cefzil
    Dosage: unk

Lipitor
    Dosage: unk
    Administration route: Oral

Livalo
    Dosage: unk

Lortab
    Dosage: unk

Oxacillin Sodium
    Dosage: unk

PCE
    Dosage: unk

Pravachol
    Dosage: unk

Provigil
    Dosage: unk

Sulfamethoxazole
    Dosage: unk

Ultram
    Dosage: unk

Zetia
    Dosage: unk

Zocor
    Dosage: unk



Possible Livalo side effects in 69 year old male

Reported by a physician from Japan on 2012-06-26

Patient: 69 year old male

Reactions: Blood Lactate Dehydrogenase Increased, Aspartate Aminotransferase Increased

Drug(s) suspected as cause:
Livalo
    Administration route: Oral

Metformin HCL
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2012-01-30
    End date: 2012-03-21

Other drugs received by patient: Novorapid; Licorice



Possible Livalo side effects in 48 year old female

Reported by a pharmacist from Japan on 2012-06-22

Patient: 48 year old female

Reactions: Myalgia, Blood Creatine Phosphokinase Increased, Myoglobin Blood Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Livalo



Possible Livalo side effects in 75 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-21

Patient: 75 year old female

Reactions: Myalgia

Drug(s) suspected as cause:
Livalo



Possible Livalo side effects in 75 year old female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: 75 year old female

Reactions: Nasopharyngitis, Pharyngeal Haemorrhage, Hypoaesthesia, Epistaxis

Drug(s) suspected as cause:
Livalo

Other drugs received by patient: Aspirin; Effient



Possible Livalo side effects in 69 year old male

Reported by a consumer/non-health professional from Germany on 2012-06-19

Patient: 69 year old male

Reactions: Aspartate Aminotransferase Increased, Blood Lactate Dehydrogenase Increased

Drug(s) suspected as cause:
Livalo
    Administration route: Oral

Metformin HCL
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2012-01-30
    End date: 2012-03-21

Other drugs received by patient: Novorapid; Licorice



Possible Livalo side effects in 42 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-15

Patient: 42 year old male

Reactions: Agranulocytosis, IGA Nephropathy, Blood Pressure Decreased, Septic Shock, Abdominal Pain Upper

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Atelec (Cilnidipine)
    Dosage: 10 mg (5 mg,2 in 1 d) per oral
    Administration route: Oral
    End date: 2012-04-18

Candesartan Cilexetil
    Dosage: 4 mg (4 mg,1 in 1 d) per oral
    Administration route: Oral
    End date: 2012-04-18

Feburic ((febuxostat)
    Dosage: 10 mg (10 mg,1 in 1 d) per oral
    Administration route: Oral
    Start date: 2012-01-26
    End date: 2012-04-18

Lansoprazole
    Dosage: 30 mg (30 mg,1 in 1 d) per oral
    Administration route: Oral
    Start date: 2012-03-08
    End date: 2012-04-18

Livalo
    Dosage: 2 mg (2 mg,1 in 1 d) per oral
    Administration route: Oral
    End date: 2012-04-18

Onelfa (Alfacalcidol)
    Dosage: 0.5 mcg (0.5 mcg,1 in 1 d) per oral
    Administration route: Oral
    Start date: 2012-03-08
    End date: 2012-04-18

Prednisolone
    Dosage: 20 mg (20 mg,1 in 1 d) per oral ; 17.5 (17.5 mg,1 in 1 d) per oral ; 15 mg (15 mg,1 in 1 d) per oral
    Administration route: Oral

Prednisolone
    Dosage: 20 mg (20 mg,1 in 1 d) per oral ; 17.5 (17.5 mg,1 in 1 d) per oral ; 15 mg (15 mg,1 in 1 d) per oral
    Administration route: Oral
    End date: 2012-04-18

Prednisolone Sodium Succinate INJ
    Dosage: 500 mg (500 mg,1 d) injection ; 500 mg (500 mg,1 d) injection ; 500 mg (500 mg,1 d) injection
    Start date: 2012-03-08

Prednisolone Sodium Succinate INJ
    Dosage: 500 mg (500 mg,1 d) injection ; 500 mg (500 mg,1 d) injection ; 500 mg (500 mg,1 d) injection

Prednisolone Sodium Succinate INJ
    Dosage: 500 mg (500 mg,1 d) injection ; 500 mg (500 mg,1 d) injection ; 500 mg (500 mg,1 d) injection

Sulfamethoxazole and Trimethoprim
    Dosage: 2 tab. (1 tab.,2 in 1 d) per oral
    Administration route: Oral
    Start date: 2012-03-08
    End date: 2012-04-18

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