DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Nimotop (Nimodipine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse experiences were reported by 92 of 823 patients with subarachnoid hemorrhage (11.2%) who were given nimodipine. The most frequently reported adverse experience was decreased blood pressure in 4.4% of these patients. Twenty-nine of 479 (6.1%) placebo treated patients also reported adverse experiences. The events reported with a frequency greater than 1% are displayed below by dose.

DOSE q4h Number of Patients (%) Nimodipine

Sign/Symptom
0.35 mg/kg
(n=82)
30 mg
(n=71)
60 mg
(n=494)
90 mg
(n=172)
120 mg
(n=4)
Placebo
(n=479)
Decreased
  Blood Pressure

1 (1.2)

0

19 (3.8)

14 (8.1)

2 (50.0)

6 (1.2)
Abnormal Liver
  Function Test

1 (1.2)

0

2 (0.4)

1 (0.6)

0

7 (1.5)
Edema002 (0.4)2 (1.2)03 (0.6)
Diarrhea03 (4.2)03 (1.7)03 (0.6)
Rash2 (2.4)03 (0.6)2 (1.2)03 (0.6)
Headache01 (1.4)6 (1.2)001 (0.2)
Gastrointestinal
  Symptoms

2 (2.4)

0

0

2 (1.2)

0

0
Nausea1 (1.2)1 (1.4)6 (1.2)1 (0.6)00
Dyspnea1 (1.2)00000
EKG Abnormalities01 (1.4)01 (0.6)00
Tachycardia01 (1.4)0000
Bradycardia005 (1.0)1 (0.6)00
Muscle Pain/Cramp01 (1.4)1 (0.2)1 (0.6)00
Acne01 (1.4)0000
Depression01 (1.4)0000

There were no other adverse experiences reported by the patients who were given 0.35 mg/kg q4h, 30 mg q4h or 120 mg q4h. Adverse experiences with an incidence rate of less than 1% in the 60 mg q4h dose group were: hepatitis; itching; gastrointestinal hemorrhage; thrombocytopenia; anemia; palpitations; vomiting; flushing; diaphoresis; wheezing; phenytoin toxicity; lightheadedness; dizziness; rebound vasospasm; jaundice; hypertension; hematoma.

Adverse experiences with an incidence rate less than 1% in the 90 mg q4h dose group were: itching, gastrointestinal hemorrhage; thrombocytopenia; neurological deterioration; vomiting; diaphoresis; congestive heart failure; hyponatremia; decreasing platelet count; disseminated intravascular coagulation; deep vein thrombosis.

As can be seen from the table, side effects that appear related to nimodipine use based on increased incidence with higher dose or a higher rate compared to placebo control, included decreased blood pressure, edema and headaches which are known pharmacologic actions of calcium channel blockers. It must be noted, however, that SAH is frequently accompanied by alterations in consciousness which lead to an under reporting of adverse experiences. Patients who received nimodipine in clinical trials for other indications reported flushing (2.1%), headache (4.1%) and fluid retention (0.3%), typical responses to calcium channel blockers. As a calcium channel blocker, nimodipine may have the potential to exacerbate heart failure in susceptible patients or to interfere with A-V conduction, but these events were not observed.

No clinically significant effects on hematologic factors, renal or hepatic function or carbohydrate metabolism have been causally associated with oral nimodipine. Isolated cases of non-fasting elevated serum glucose levels (0.8%), elevated LDH levels (0.4%), decreased platelet counts (0.3%), elevated alkaline phosphatase levels (0.2%) and elevated SGPT levels (0.2%) have been reported rarely.



REPORTS OF SUSPECTED NIMOTOP SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Nimotop side effects / adverse reactions in 68 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-13

Patient: 68 year old male

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Suspect drug(s):
Atorvastatin
    Dosage: 1 df, 1x/day
    Administration route: Oral

Omeprazole
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Start date: 2008-12-05
    End date: 2008-12-19

Pantoprazole Sodium
    Dosage: unk
    Start date: 2008-11-18
    End date: 2008-12-05

Phenytoin Sodium

Nimotop
    Administration route: Oral

Lovenox
    Dosage: 1 df, 1x/day
    Start date: 2008-11-07
    End date: 2008-12-19

Other drugs received by patient: Tramadol HCL; Alfuzosin HCL; Polaramine; Paracetamol; Xyzal



Possible Nimotop side effects / adverse reactions in 68 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-15

Patient: 68 year old male

Reactions: Subcorneal Pustular Dermatosis, Pemphigus, Acute Generalised Exanthematous Pustulosis, Impetigo, Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Suspect drug(s):
Nimotop
    Dosage: unk
    Administration route: Oral
    Start date: 2008-12-10
    End date: 2008-12-15

Pantoprazole Sodium
    Dosage: unknown
    Administration route: Oral
    Start date: 2008-11-18
    End date: 2008-12-05

Nimotop
    Dosage: unk
    Administration route: Oral
    Start date: 2008-11-07
    End date: 2008-12-05

Omeprazole
    Dosage: unk
    Administration route: Oral
    Start date: 2008-12-05
    End date: 2008-12-19

Atorvastatin
    Dosage: 40, 1x/day
    Administration route: Oral
    Start date: 2008-11-10
    End date: 2008-12-19

Phenytoin Sodium
    Dosage: unk
    Administration route: Oral
    Indication: Convulsion
    Start date: 2008-11-07
    End date: 2008-12-19

Lovenox
    Dosage: 0.4 ml/day
    Start date: 2008-11-07
    End date: 2008-12-19

Other drugs received by patient: Tramadol HCL; Paracetamol; Ciprofloxacin; Polaramine; Corvasal; Xyzal; Alfuzosin HCL



See index of all Nimotop side effect reports >>

Drug label data at the top of this Page last updated: 2008-04-10

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014