RECTIV SIDE EFFECTS
- Generic Name: nitroglycerin
- Brand Name: Rectiv
- Drug Class: Gastrointestinal Agents, Other
SIDE EFFECTS
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.
The most common adverse reaction of RECTIV (nitroglycerin) Ointment 0.4% applied to the anal canal is headache.
Headache may be recurrent following each dose. Headaches are typically of short duration and can be treated with an analgesic, e.g. acetaminophen, and are reversible upon discontinuation of treatment.
In Study REC-C-001, a double-blind, placebo-controlled trial in patients with a painful chronic anal fissure, the most frequent ( ≥ 2%) adverse reactions reported were as follows (Table 1):
Table 1: Incidence of Adverse Reactions ( ≥ 2%) in Study REC-C-001
| System Organ Class Preferred term | RECTIV N = 123 |
Placebo N =124 |
||
| Patients n (%) |
Events n |
Patients n (%) |
Events n |
|
| Nervous system disorders | ||||
| Headache | 79 (64) | 938 | 51 (41) | 225 |
| Dizziness | 6 (5) | 26 | 0 | 0 |
Hypotension
Transient episodes of light-headedness, occasionally related to blood pressure changes, also may occur. Hypotension (including orthostatic hypotension) occurs infrequently, but in some patients may be severe enough to warrant discontinuation of therapy.
Allergic Reactions
Flushing, allergic reactions and application site reactions (including drug rash and exfoliative dermatitis) have been reported rarely.
Methemoglobinemia
In rare cases, therapeutic doses of organic nitrates have caused methemoglobinemia.
SRC: NLM .