Persantine (Dipyridamole) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of PERSANTINE (dipyridamole USP) tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing PERSANTINE tablets and warfarin therapy to either warfarin alone or warfarin and placebo:

Table 1 Adverse Reactions Reported in 2 Heart Valve Replacement Trials

	PERSANTINE
Adverse	Tablets/	Placebo/
Reaction	Warfarin	Warfarin
Number of patients	147	170
Dizziness	13.6%	8.2%
Abdominal distress	6. 1%	3.5%
Headache	2.3%	0.0%
Rash	2.3%	1.1%

Other reactions from uncontrolled studies include diarrhea, vomiting, flushing and pruritus. In addition, angina pectoris has been reported rarely and there have been rare reports of liver dysfunction. On those uncommon occasions when adverse reactions have been persistent or intolerable, they have ceased on withdrawal of the medication.

When PERSANTINE tablets were administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone. In rare cases, increased bleeding during or after surgery has been observed.

In post-marketing reporting experience, there have been rare reports of hypersensitivity reactions (such as rash, urticaria, severe bronchospasm, and angioedema), larynx edema, fatigue, malaise, myalgia, arthritis, nausea, dyspepsia, paresthesia, hepatitis, thrombocytopenia, alopecia, cholelithiasis, hypotension, palpitation, and tachycardia.

REPORTS OF SUSPECTED PERSANTINE SIDE EFFECTS / ADVERSE REACTIONS

Possible Persantine side effects / adverse reactions in 78 year old male

Reported by a consumer/non-health professional from United States on 2012-01-19

Patient: 78 year old male

Reactions: Drug Intolerance

Suspect drug(s):
Persantine

Possible Persantine side effects / adverse reactions in 93 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-09

Patient: 93 year old female

Reactions: Gastric Haemorrhage

Adverse event resulted in: hospitalization

Suspect drug(s):
Aspirin
    Dosage: 75 mg
    Administration route: Oral
    End date: 2012-05-25

Persantine
    Dosage: 200 mg
    Administration route: Oral
    End date: 2012-05-30

Other drugs received by patient: Diphenhydramine HCL; Zopiclone

Possible Persantine side effects / adverse reactions in 57 year old male

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

Patient: 57 year old male

Reactions: Pneumonia, Lower Respiratory Tract Infection

Adverse event resulted in: life threatening event, hospitalization, disablity

Suspect drug(s):
Clozaril
    Dosage: 550 mg
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2010-03-01

Clozaril
    Administration route: Oral
    Indication: Schizoaffective Disorder
    Start date: 2005-11-02

Persantine
    Dosage: 400 mg
    Administration route: Oral

Sodium Decanoate
    Dosage: 200 mg
    Administration route: Oral

Other drugs received by patient: Aspirin; Hyoscine HBR HYT; Lactulose; Metformin Hydrochloride; Venlafaxine; Metoclopramide; Aspirin; Atorvastatin; Albuterol Sulate; Fluticasone Propionate/salmeterol; Omeprazole; Pizotifen; Senna-Mint WAF