Aliskiren Hemifumarate side effects: what 5,999 FDA adverse event reports show
Drug class
Renin inhibitor (ri)
Brand names
Tekturna
Who reports
5,999 reports · 71% serious · 744 with death outcome · 60% female
Used for
Tekturna is a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
What it is
Tekturna contains aliskiren hemifumarate, adirect renin inhibitor. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy- 2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is:
Boxed warning
FETAL TOXICITY When pregnancy is detected, discontinue Tekturna as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 300 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Affect lability | 262 | 97.3 86.3–109.8ROR 101.7 · χ² 24,215 / p <1e-300 | 94.1 EB05 84.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 107.8 · ♀ 100% (drug 60%) | no trial data cached |
| Motor dysfunction | 261 | 92.6 82.1–104.4ROR 96.7 · χ² 22,945 / p <1e-300 | 89.6 EB05 80.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 92.6 · ♀ 100% (drug 60%) | no trial data cached |
| Ocular discomfort | 232 | 76.3 67.2–86.7ROR 79.3 · χ² 16,801 / p <1e-300 | 74.2 EB05 66.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=230 · 91% clinician | no trial data cached |
| Muscle spasticity | 262 | 75.4 66.9–85.0ROR 78.8 · χ² 18,768 / p <1e-300 | 73.5 EB05 66.3 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 85.8 · ♀ 100% (drug 60%) | no trial data cached |
| Coordination abnormal | 265 | 67.2 59.7–75.7ROR 70.3 · χ² 16,897 / p <1e-300 | 65.6 EB05 59.3 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 74.0 · ♀ 99% (drug 60%) | no trial data cached |
| Generalised oedema | 220 | 63.6 55.8–72.5ROR 66.0 · χ² 13,251 / p <1e-300 | 62.1 EB05 55.5 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 56.5 · 95% clinician | no trial data cached |
| Hemiparesis | 271 | 56.5 50.2–63.5ROR 59.1 · χ² 14,483 / p <1e-300 | 55.4 EB05 50.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 49.0 · ♀ 97% (drug 60%) | no trial data cached |
| Sinus congestion | 189 | 49.5 43.0–57.0ROR 51.1 · χ² 8,812 / p <1e-300 | 48.6 EB05 43.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=189 · ♀ 100% (drug 60%) · 95% clinician | no trial data cached |
| Skin haemorrhage | 194 | 47.6 41.4–54.7ROR 49.2 · χ² 8,695 / p <1e-300 | 46.8 EB05 41.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=192 · ♀ 100% (drug 60%) · 95% clinician | no trial data cached |
| Head discomfort | 232 | 46.6 41.1–53.0ROR 48.5 · χ² 10,187 / p <1e-300 | 45.9 EB05 41.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 66.2 · 92% clinician | no trial data cached |
| Eating disorder | 264 | 43.7 38.8–49.2ROR 45.7 · χ² 10,847 / p <1e-300 | 43.0 EB05 38.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 48.5 · ♀ 99% (drug 60%) | no trial data cached |
| Respiratory tract congestion | 182 | 40.4 35.0–46.7ROR 41.7 · χ² 6,887 / p <1e-300 | 39.8 EB05 35.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 75.4 · ♀ 100% (drug 60%) · 94% clinician | no trial data cached |
| Altered state of consciousness | 227 | 37.2 32.7–42.3ROR 38.6 · χ² 7,884 / p <1e-300 | 36.7 EB05 32.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 30.3 · 93% clinician | no trial data cached |
| Sinus disorder | 198 | 35.2 30.7–40.4ROR 36.4 · χ² 6,493 / p <1e-300 | 34.8 EB05 30.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 60.1 · ♀ 98% (drug 60%) · 93% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 245 | 34.0 30.1–38.5ROR 35.4 · χ² 7,749 / p <1e-300 | 33.6 EB05 30.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 · 93% clinician | no trial data cached |
| Photophobia (light sensitivity) | 178 | 33.6 29.1–38.9ROR 34.6 · χ² 5,555 / p <1e-300 | 33.2 EB05 29.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 43.1 · 92% clinician | no trial data cached |
| Aphasia (loss of speech) | 270 | 31.4 28.0–35.3ROR 32.9 · χ² 7,866 / p <1e-300 | 31.1 EB05 28.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 30.2 · ♀ 99% (drug 60%) | no trial data cached |
| Presyncope (near-fainting) | 215 | 31.3 27.5–35.7ROR 32.5 · χ² 6,233 / p <1e-300 | 31.0 EB05 27.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 32.3 · 94% clinician | no trial data cached |
| Sneezing | 190 | 29.9 26.0–34.5ROR 30.9 · χ² 5,247 / p <1e-300 | 29.6 EB05 26.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 60.2 · ♀ 100% (drug 60%) · 95% clinician | no trial data cached |
| Diplopia (double vision) | 208 | 28.2 24.7–32.3ROR 29.2 · χ² 5,394 / p <1e-300 | 27.9 EB05 24.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 30.9 · 93% clinician | no trial data cached |
| Dysarthria (slurred speech) | 292 | 27.3 24.4–30.6ROR 28.7 · χ² 7,337 / p <1e-300 | 27.1 EB05 24.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 26.2 · ♀ 96% (drug 60%) | no trial data cached |
| Ascites | 228 | 27.3 24.0–31.0ROR 28.3 · χ² 5,713 / p <1e-300 | 27.0 EB05 24.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 · 93% clinician | no trial data cached |
| Angina pectoris | 217 | 26.5 23.2–30.2ROR 27.4 · χ² 5,263 / p <1e-300 | 26.2 EB05 23.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.2 · ♀ 83% (drug 60%) · 93% clinician | no trial data cached |
| Haematuria (blood in urine) | 217 | 22.2 19.5–25.4ROR 23.0 · χ² 4,361 / p <1e-300 | 22.1 EB05 19.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 · 93% clinician | no trial data cached |
| Abortion induced | 58 | 21.6 16.7–28.0ROR 21.8 · χ² 1,114 / p 1e-244 | 21.4 EB05 17.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 · ♀ 100% (drug 60%) | no trial data cached |
| Cystitis | 196 | 21.6 18.8–24.8ROR 22.3 · χ² 3,805 / p <1e-300 | 21.4 EB05 19.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 23.5 · ♀ 99% (drug 60%) · 94% clinician | no trial data cached |
| Blindness | 235 | 20.3 17.9–23.0ROR 21.1 · χ² 4,273 / p <1e-300 | 20.1 EB05 18.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · 93% clinician | no trial data cached |
| Cardio-respiratory arrest | 238 | 19.9 17.5–22.5ROR 20.7 · χ² 4,231 / p <1e-300 | 19.7 EB05 17.7 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 16.2 · 93% clinician | no trial data cached |
| Diabetes mellitus inadequate control | 92 | 18.2 14.9–22.4ROR 18.5 · χ² 1,476 / p <1e-300 | 18.1 EB05 15.2 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.4 · ♀ 91% (drug 60%) · 91% clinician | no trial data cached |
| Coma | 229 | 16.9 14.9–19.2ROR 17.5 · χ² 3,393 / p <1e-300 | 16.8 EB05 15.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 · 93% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 214 | 16.3 14.3–18.6ROR 16.9 · χ² 3,056 / p <1e-300 | 16.2 EB05 14.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 19.8 · 91% clinician | no trial data cached |
| Eye pain | 240 | 15.3 13.5–17.3ROR 15.8 · χ² 3,176 / p <1e-300 | 15.2 EB05 13.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.0 | no trial data cached |
| Blood pressure increased | 622 | 14.2 13.2–15.3ROR 15.8 · χ² 7,671 / p <1e-300 | 14.2 EB05 13.3 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 14.7 | no trial data cached |
| Hyperkalaemia (high potassium) | 118 | 11.9 9.9–14.2ROR 12.1 · χ² 1,160 / p 2e-254 | 11.7 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.8 · ♀ 37% (drug 60%) · 98% clinician | no trial data cached |
| Blood potassium increased | 54 | 11.7 8.9–15.2ROR 11.8 · χ² 515 / p 3e-114 | 11.4 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.7 · ♀ 40% (drug 60%) | no trial data cached |
| Blood urea increased | 56 | 11.7 9.0–15.1ROR 11.8 · χ² 534 / p 2e-118 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 9.6 · 98% clinician | no trial data cached |
| Cataract | 186 | 11.0 9.5–12.7ROR 11.3 · χ² 1,679 / p <1e-300 | 10.9 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 97% (drug 60%) | no trial data cached |
| Dysphagia (difficulty swallowing) | 296 | 11.0 9.8–12.3ROR 11.5 · χ² 2,673 / p <1e-300 | 10.9 EB05 9.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · ♀ 95% (drug 60%) | no trial data cached |
| Rhinorrhoea (runny nose) | 201 | 10.9 9.5–12.5ROR 11.3 · χ² 1,804 / p <1e-300 | 10.8 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 · ♀ 100% (drug 60%) · 91% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 264 | 10.4 9.3–11.7ROR 10.8 · χ² 2,240 / p <1e-300 | 10.3 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · 90% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nausea | 661 | 2.9 2.7–3.1ROR 3.2 · χ² 871 / p 1e-191 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · ♀ 84% (drug 60%) | no trial data cached |
| Blood pressure increased | 622 | 14.2 13.2–15.3ROR 15.8 · χ² 7,671 / p <1e-300 | 14.2 EB05 13.3 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 14.7 | no trial data cached |
| Headache | 612 | 3.4 3.2–3.7ROR 3.7 · χ² 1,076 / p 3e-236 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Fatigue (tiredness) | 611 | 2.8 2.6–3.0ROR 2.9 · χ² 705 / p 1e-155 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Fall | 590 | 6.2 5.8–6.7ROR 6.8 · χ² 2,612 / p <1e-300 | 6.2 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 90% (drug 60%) | no trial data cached |
| Asthenia (weakness) | 583 | 5.4 5.0–5.9ROR 5.9 · χ² 2,135 / p <1e-300 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 81% (drug 60%) | no trial data cached |
| Cough | 539 | 6.7 6.2–7.3ROR 7.3 · χ² 2,662 / p <1e-300 | 6.7 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 · ♀ 83% (drug 60%) | no trial data cached |
| Dizziness | 538 | 3.8 3.5–4.1ROR 4.1 · χ² 1,123 / p 2e-246 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Dyspnoea (shortness of breath) | 527 | 3.3 3.0–3.5ROR 3.5 · χ² 845 / p 4e-186 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Malaise (feeling unwell) | 524 | 4.2 3.8–4.5ROR 4.5 · χ² 1,285 / p 9e-282 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 85% (drug 60%) | no trial data cached |
| Vomiting | 467 | 3.5 3.2–3.8ROR 3.7 · χ² 843 / p 1e-185 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · ♀ 83% (drug 60%) | no trial data cached |
| Diarrhoea (diarrhea) | 460 | 2.5 2.3–2.7ROR 2.6 · χ² 426 / p 7e-95 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Pyrexia (fever) | 419 | 4.2 3.9–4.6ROR 4.5 · χ² 1,048 / p 3e-230 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 87% (drug 60%) · 93% clinician | no trial data cached |
| Cerebrovascular accident (stroke) | 405 | 8.3 7.6–9.2ROR 8.9 · χ² 2,625 / p <1e-300 | 8.3 EB05 7.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 89% (drug 60%) | no trial data cached |
| Hypertension (high blood pressure) | 346 | 5.7 5.2–6.3ROR 6.0 · χ² 1,352 / p 3e-296 | 5.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.0 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Affect lability — n=262, PRR 97.3
- Motor dysfunction — n=261, PRR 92.6
- Ocular discomfort — n=232, PRR 76.3
- Muscle spasticity — n=262, PRR 75.4
- Coordination abnormal — n=265, PRR 67.2
- Generalised oedema — n=220, PRR 63.6
- Hemiparesis — n=271, PRR 56.5
- Sinus congestion — n=189, PRR 49.5
- Skin haemorrhage — n=194, PRR 47.6
- Head discomfort — n=232, PRR 46.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Aliskiren ↔ Hyperkalaemia.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Aliskiren Hemifumarate?
In FDA FAERS, the most frequently co-reported reaction terms for Aliskiren Hemifumarate are nausea, blood pressure increased, headache, fatigue, fall, asthenia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Aliskiren Hemifumarate have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue Tekturna as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
Do FAERS signals prove that Aliskiren Hemifumarate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2, effective 20240307; matched on
openfda.generic_name.exact:"ALISKIREN HEMIFUMARATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 340 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.