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Adcirca (Tadalafil) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Hypotension [see Warnings and Precautions ]
  • Visual Loss [see Warnings and Precautions and Patient Counseling Information]
  • Hearing loss [see Warnings and Precautions ]
  • Priapism [see Warnings and Precautions]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tadalafil was administered to 398 patients with PAH during clinical trials worldwide. In trials of ADCIRCA, a total of 311 and 251 subjects have been treated for at least 182 days and 360 days, respectively. The overall rates of discontinuation because of an adverse event (AE) in the placebo-controlled trial were 9% for ADCIRCA 40 mg and 15% for placebo. The rates of discontinuation because of AEs, other than those related to worsening of PAH, in patients treated with ADCIRCA 40 mg was 4% compared to 5% in placebo-treated patients.

In the placebo-controlled study, the most common AEs were generally transient and mild to moderate in intensity. Table 1 presents treatment-emergent adverse events reported by ≥9% of patients in the ADCIRCA 40 mg group and occurring more frequently than with placebo.

TABLE 1: Treatment-Emergent Adverse Events Reported by ≥9% of Patients in ADCIRCA and More Frequent than Placebo by 2%
EVENT Placebo (%)
(N=82)
ADCIRCA 20 mg (%)
(N=82)
ADCIRCA 40 mg (%)
(N=79)
Headache 15 32 42
Myalgia 4 9 14
Nasopharyngitis 7 2 13
Flushing 2 6 13
Respiratory Tract Infection (Upper and Lower) 6 7 13
Pain in Extremity 2 5 11
Nausea 6 10 11
Back Pain 6 12 10
Dyspepsia 2 13 10
Nasal Congestion (Including sinus congestion) 1 0 9

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of tadalafil. These events have been chosen for inclusion either because of their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section.

Cardiovascular and cerebrovascular — Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of tadalafil without sexual activity. Others were reported to have occurred hours to days after the use of tadalafil and sexual activity. It is not possible to determine whether these events are related directly to tadalafil, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions ].

Body as a whole — Hypersensitivity reactions including urticaria, Stevens–Johnson syndrome, and exfoliative dermatitis

Nervous — Migraine, seizure and seizure recurrence, and transient global amnesia

Ophthalmologic — Visual field defect, retinal vein occlusion, and retinal artery occlusion

Otologic — Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of tadalafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions and Patient Counseling Information].

Urogenital — Priapism [see Warnings and Precautions].



REPORTS OF SUSPECTED ADCIRCA SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Adcirca side effects / adverse reactions in 75 year old female

Reported by a physician from United States on 2011-10-07

Patient: 75 year old female

Reactions: Hospitalisation, Renal Impairment

Adverse event resulted in: hospitalization

Suspect drug(s):
Adcirca

Other drugs received by patient: Pravachol; Welchol; Clonazepam; Ascorbic Acid; Urecholine



Possible Adcirca side effects / adverse reactions in 67 year old female

Reported by a physician from Japan on 2011-10-13

Patient: 67 year old female

Reactions: Organising Pneumonia, Cardiac Failure, Atrial Fibrillation, Shock

Adverse event resulted in: life threatening event

Suspect drug(s):
Adcirca

Other drugs received by patient: Aspenon; Dobutrex



Possible Adcirca side effects / adverse reactions in 82 year old male

Reported by a physician from Japan on 2011-11-07

Patient: 82 year old male

Reactions: Pyrexia, Blood Pressure Decreased, Asthenia, Decreased Appetite

Adverse event resulted in: hospitalization

Suspect drug(s):
Adcirca
    Dosage: 40 mg, daily (1/d)
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2010-09-01

Adcirca
    Dosage: 20 mg, daily (1/d)
    Administration route: Oral
    Start date: 2010-10-08

Other drugs received by patient: Diuretics; Beraprost Sodium



See index of all Adcirca side effect reports >>

Drug label data at the top of this Page last updated: 2014-04-29

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